Logo
Registered Members Login:
   
Forgotten Your Details? Click Here To Recover +
Welcome to ShareScene - Talk Shares And Take Stock With Australia's Sharemarket Community - New Here? Click To Register >

Important Notice For All Members - ShareScene Is Moving

3 Pages (Click to Jump) V   1 2 3 >

Frogster
Posted on: Dec 8 2018, 10:13 AM


Group: Member
Posts: 517

This is now a moot point - and I'm not sure if you're saying you don't think they got an RTF or if you're saying we should simply move on from questioning if they did or didn't - but if it's the former, then in my reading of it I don't think they actually stated they didn't get an RTF.

As you have quoted below, they stated that "no major outstanding issues....would lead or need to lead to a refusal to file". To me this still leaves room for a minor issue (or issues) which could, and perhaps did, lead to an RTF.

The reason the point is moot is because they have clearly also stated they have now "provided answers to each individual question to satisfy these latest regulatory requests", and I don't think there's any room for interpreting that in any other way than to understand they have answered whatever questions the FDA had and, making an implicit assumption support by this and other statements, things are rolling again.

My best guess is that they:

- got an RTF on minor issues only
- answered the issues quickly
- refiled, and we're now in the 2nd validation period

I cannot see another way that CUV statements and actions around this issue fit with my understanding of FDA processes.

I think, come an assumed filing acceptance and PDUFA date, all this will become a minor historical hiccup, and just another example of the sometimes frustrating lack of precision and explicit clarity that CUV communications bring. Less than perfect clarity from CUV is nothing new to any of us who've been around here for a while. If we get an FDA approval within the next 10-12 months, I expect I'll be happy with the result even if I've had a few grumbles along the way about how we got there.
  Forum: By Share Code

Frogster
Posted on: Nov 26 2018, 09:38 AM


Group: Member
Posts: 517

The incidence of inherited porphyrias in Europe (2012) by George Elder, Pauline Harper, Michael Badminton, Sverre Sandberg & Jean-Charles Deybach put the number, based on incidence, at 286.
  Forum: By Share Code

Frogster
Posted on: Nov 21 2018, 03:18 PM


Group: Member
Posts: 517

Well, what is there to say about the AGM 2018?

Not much of any great note. I don’t think I really learnt very much new, neither good nor bad. We know CUV is a company that doesn’t hype itself, and that was on display in spades. We’ve seen before that PW’s style and M.O. is one of caution. No Elon Musk type hype from this guy, ever, in my expectation. That’s neither good nor bad I guess, it’s just the way it is, and it’ll never change.

In no particular order:

Aspects of the presentation were historic in nature, and struck me as a new way of presenting old information. I guess there will always be an element of this in an AGM presentation. Regarding forward looking stuff, PW was very limited in his commentary. He cited confidentiality arrangements, and really gave no “update” on key issues of NICE or the FDA. I didn’t get the sense this was for any negative reason, but rather due to an abundance of caution.

If last years AGM saw an expansion of detail on expected milestones, timelines and events, then this year saw a reversion to the default position of saying as little as possible. I’m note sure if that was due to being a little burnt by the things they “missed” doing in the last year, or whether it was due to the current hiatus with the FDA putting everything in hold. A bit of both probably. If it wasn’t already obvious that the last newsletter, which saw PW answer minimally some key questions we’ve had (i.e. where’s the OTC gone?), then it became very clear that was done to head those questions off at the pass prior to today.

Vitiligo: some reasonable time was spent on this. CUV103 was announced as being almost ready AGAIN. How many consecutive AGMs is that now? 3? 4? 5? They must surely have some insight on the data by now, and to keep mentioning it must suggest the data is good (to me at least). It seems obvious they are just waiting for the time to be “right” before revealing. When is “right”? FDA progress on EPP is my guess.

Brief presentation by Blijdorp. He talked a bit about his long running history with CUV, about his belief that people make the difference in companies, and why he spent up big to take his stake. As per his section in the A.R., this seemed to be another stage is introducing him to us. It did nothing to reduce the view that he’s being lined up as the next Chair after Stan finally retreats from the stage. As a very successful businessman Blijdorp is due respect. His reserved, unflashy presentation style appears similar to that of PW.

Prof Minder from Tremli said a few words. She’s administered over 1,300 implants. To her patients, and in her professional view, the product works, and has only minor side effects. Nice to hear first hand what we already have read from many locations. In fact, I’m sure I could hear a low level background chant of along the lines of “safe and effective” being piped over the PA throughout proceedings.

Japan/Australia in EPP was presented as having the same pipeline status as the US. Does that mean an application has been lodged? Sorry, not clear on that.

On the disclosure question below, there are two different things in play. PW mentioned that the company will continue to report quarterly cash flows (the 4C), even though we know they now probably don’t have to. He also stated separately that the frequency of reporting safety data under the Post Authorisation safety protocols to the EMA drops from every 6m to every 12m. Two very different things obviously.

Much flasher location than last year, and particularly the year before. I don’t know that there were many more attendees than previous years. Maybe a few, but not that many. Flashy ceiling to floor screen on the stage, but not helpful to have annotations and translations lost at the bottom of if by the back of the head of the person in front of you.

Overall, if you didn’t make the trip over, you didn’t miss much. Nothing major new bad. Nothing major new good. FDA is the only real game in town, and there’s nothing new to add to that just now.

  Forum: By Share Code

Frogster
Posted on: Nov 19 2018, 09:24 AM


Group: Member
Posts: 517

I believe a number of the usual suspects will be attending.
Regarding Q&A, the allocated time has never been a limiting factor. Historically not all that many questions have been asked - perhaps up to 8 or 9 - and some might suggest not all that many have been answered either.
In the context of significantly more comms effort this year, it will be interesting to see if they take a more generous, engaged approach to the answers this year.
  Forum: By Share Code

Frogster
Posted on: Nov 16 2018, 03:11 PM


Group: Member
Posts: 517

Didn't he say early Christmas present for 2019? It wouldn't rule out early 2019, but I'm pretty sure those were his words.
  Forum: By Share Code

Frogster
Posted on: Nov 14 2018, 03:43 PM


Group: Member
Posts: 517

Thanks so much for posting.

He seemed to be smiling alot more than he usually does at the AGM.
  Forum: By Share Code

Frogster
Posted on: Nov 12 2018, 03:01 PM


Group: Member
Posts: 517

Is the Walnut paid too much? A rather simplistic analysis, but for what it's worth:

https://simplywall.st/stocks/au/pharmaceuti...stay-motivated/
  Forum: By Share Code

Frogster
Posted on: Nov 5 2018, 02:16 PM


Group: Member
Posts: 517

Also, hopeful NICE will engage in a managed access scheme and the delay in the OTC product line was due to issues at a supplier - now hopeful of launch in the New Year.

Furthermore, some defence of the Chairman against those who were critical of his comment that the further FDA questions were antcipated before the NDA.
  Forum: By Share Code

Frogster
Posted on: Oct 30 2018, 06:58 PM


Group: Member
Posts: 517

I've been on the road these last few weeks, and not been following in detail (probably just as well). Have they actually said they've submitted the extra info, or have they only said fda hasn't commented on time lines? I know this was the case when they announced the initial delay (throw shade at the fda, but hide from the fact a large part is 100% down to them) but I wasn't aware that the first stage to solution (to answer the query) had been reached. I sure hope it has!
  Forum: By Share Code

Frogster
Posted on: Oct 15 2018, 07:35 PM


Group: Member
Posts: 517

Probably just 10 of us checking in 9,000 times each.
  Forum: By Share Code

Frogster
Posted on: Oct 12 2018, 07:39 AM


Group: Member
Posts: 517

Anyone who owns CUV shares is entitled to attend. Doesn't matter how many or how few. It's a bit more murky for CLVLY and UR9 holders. Some have (I believe) been denied entry previously, and CUV has not enterred into a dialogue (as far as I know) about how to arrange entry for these holders. I suppose a CUV holder might be able to nominate someone as proxy to vote their shares (or perhaps just 1 of their shares). I don't know if being a proxy also entitles you to ask questions.
In the past they have never been recorded, broadcast or transmitted. Doubtful that will change - you have to be in the room.
  Forum: By Share Code

Frogster
Posted on: Oct 12 2018, 07:16 AM


Group: Member
Posts: 517

Wouldn't it be handy if the answers to those extra 2 questions and resultant acceptance of the NDA coincided with the AGM where we might just be asked to vote on the NEXT performance rights plan?
  Forum: By Share Code

Frogster
Posted on: Oct 4 2018, 02:32 PM


Group: Member
Posts: 517

Clearly Lagoda has sold a bunch of shares on the market, but this announcement also highlights that Richard Bayles has left Lagoda and, seemingly, taken a bunch of accounts (Brown Brothers, JPM, State Street, US Trust, Wells Fargo) with him.
It looks like he might have gone to Oppenheimer, and presumably they will now be managing these shares instead.

Lagoda loosing the mandate to run these funds looks to be a bigger factor in them ceasing to be a substantial holder rather than quantum of the listed disposals (which I only added up by eye).
  Forum: By Share Code

Frogster
Posted on: Sep 26 2018, 10:30 PM


Group: Member
Posts: 517

$40 share price (or more) might be possible in that time frame with positive fda news, 2nd indication, good cuv103 results, asx200 etc. etc., but I don't expect we'll be seeing A$94m annual revenues and A$76m earnings in a reporting period that closes 9 months from now. I'm very excited by what's finally going on, but I'm trying to keep some realism about how the business is likely to progress. Remember this is CUV. Between hares and tortoises, they have a very hard shell.
  Forum: By Share Code

Frogster
Posted on: Sep 26 2018, 09:49 PM


Group: Member
Posts: 517

I'm not sure what you mean by 1,200 "confirmed patients".
If you mean patients being continually treated today, that sounds pretty high to me.

In the recent 4E and the NDA submission announcement from 25/6/18 they pointed out the data set submitted to the FDA (i.e. pretty much everything the know about the drug) encompassed "nearly 6,700 afamelanotide doses administered to more than 800 patients" and in more recent presentations they've been talking about >7,900 doses and >975 patients in 34 clinical trials.

Of these 800-975, this includes many from trials in regions which are not currently reimbursing the product and it's not all patients in trials for EPP alone. I don't think CUV has given an official number of current EPP patients, but if revenue is circa A$26m annually (FY17-18), and approx treatment cost E70k*1.62 then that equates to a current patient population well below 1,200. A few hundred at present it would seem. Sure, we can hope for growth here, but it will take time.

I'm not saying there isn't the prospect of strong growth over coming years, especially with a US approval, but I think we're quite some way from A$94m revenue on European EPP alone.
Totally agree with the growth drivers you've listed thereafter.
  Forum: By Share Code

Frogster
Posted on: Sep 22 2018, 05:28 PM


Group: Member
Posts: 517

Maybe they'll correct "Clivucel" too rolleyes.gif .
  Forum: By Share Code

Frogster
Posted on: Sep 22 2018, 03:08 PM


Group: Member
Posts: 517

From yesterday:

https://scrip.pharmaintelligence.informa.co...n-Drug-Scenesse

It won't let me start a free trial for some reason. Can anyone else access the interview and share it here?

Damn. Beaten by odi01.
  Forum: By Share Code

Frogster
Posted on: Sep 21 2018, 04:11 PM


Group: Member
Posts: 517

A casual 576,000 shares traded for the day, with another 540,000 still (currently) showing on the bid.
A happy weekend to one and all longs.
  Forum: By Share Code

Frogster
Posted on: Sep 21 2018, 04:05 PM


Group: Member
Posts: 517

Interesting post close market depth!
I guess this is a pre ASX300 inclusion thing.
Will be interesting to see how the post close auction pans out.
  Forum: By Share Code

Frogster
Posted on: Sep 20 2018, 10:03 AM


Group: Member
Posts: 517

PW emerges.
Attached File(s)
Attached File  02024364.pdf ( 1.73MB ) Number of downloads: 146

 
  Forum: By Share Code

Frogster
Posted on: Sep 11 2018, 07:42 AM


Group: Member
Posts: 517

39,328 share trade at 18.462 showing on CHI-X already today. I wonder if that's a hangover from yesterday, or genuinely from today.
  Forum: By Share Code

Frogster
Posted on: Sep 10 2018, 01:53 PM


Group: Member
Posts: 517

At the current share price our mkt cap is bigger than 6 companies currently in the ASX200.
Just saying.....
  Forum: By Share Code

Frogster
Posted on: Sep 8 2018, 07:41 AM


Group: Member
Posts: 517

Hi Peter. Welcome to Sharescene. That must be the most liked first post ever on this forum!
Thanks very much for your research on CUV - it's very much appreciated.


  Forum: By Share Code

Frogster
Posted on: Sep 5 2018, 07:31 PM


Group: Member
Posts: 517

I've just been putting together some similar thoughts to you Mauricinho. I was typing this whilst you posted your view:
I've been trying to get my head around where we are in the application process, and I must say I've now worn a nice neat circle in my carpet.

On 23/8 CUV88 posted the following link:

https://www.fda.gov/downloads/AboutFDA/Cent...s/UCM218757.pdf

This is an FDA desk reference guide (a 59 page summary) to the CDER process for reviewing NDAs dated Sept 2014. It's a few years old, but I can't find any updated process so let's assume it's current. It highlights all the dates by which FDA actions must take place, and what those actions mean.

The bulk of what's relevant today is between p17 and p21, though Appendix A is also very useful. Points to note:


1) Preliminary FDA decision on Priority/Standard review designation is made by Day 14 after application receipt. (Appendix A)

2) Priority/Standard review designation is confirmed at the Filing Review which will take place by Day 45 for Standard review or by Day 30 for Priority review. (Appendix A & p17)

3) At the Filing Meeting there are 3 potential decisions (p20):

a. File the application (no major omissions or deficiencies, minor issues may exist)

b. Potentially RTF the application (correctable deficiencies exist, if they are fixed by Day 60, the application is filed)

c. RTF (deficiencies cannot be rectified readily)

4) For filed (accepted) Priority reviews a "Filing Notification" letter will be issued by Day 60, along with a "No Filing Issues Identified" letter by Day 60, or a "Filing Issues Identified" letter between Day 60 and Day 74. (p21)

5) For filed (accepted) Standard reviews a "Filing Notification" letter will be issued by Day 74 along with a "No Filing Issues Identified" letter or the "Filing Issues Identified" letter. (p21)

6) "Program" Review Timelines for filed applications will be submitted by Day 74 i.e. FDA communicates ongoing timelines promptly. (Appendix A & Section 3.3)

7) - If an RTF decision is taken at the Filing Meeting, an RTF letter will be issued within 60 days. An RTF ends the review process. The NDA will have to be resubmitted with deficiencies addressed and will be considered a new application, or they can be "filed over protest". (p20)

So, what does all this mean about where Clinuvel is in the application process? If we consider that Clinuvel has made a single NDA application on 22 June, then the FDA will have made its Priority review decision at the Filing Meeting held within 30 days of that. If CUV is telling us no Priority Review decision has been made, then I cannot see how that can be the case for a "still live" NDA made on 22 June. There appears to be no process "pause" button, no "extension" process which can push back the Priority Review decision. It seems that at this stage the 22 June application is either filed, or it is not. If it is not, then CUV has had an RTF letter, which it would have had by Day 60 – 2 weeks ago (Continuous Disclosure anyone?). If we've had an RTF letter, then that application is dead - apart from if they've filed under protest, but then a Priority Review decision would've been made - and another application will have to be made.

If it is filed, then CUV would've been informed by the FDA of its review status either way.

So, the only thing to me that makes sense is that they've had an RTF letter and will need to resubmit the entire NDA with corrected deficiencies. If no resubmission has yet occurred, then of course no further timelines can possibly have been provided by the FDA. If a resubmission has occurred, then the timelines are known. I don't think we currently have an NDA in front of the FDA.

If this is the case, then it's at best a pretty disingenuous release today. At worst it's highly misleading.
  Forum: By Share Code

Frogster
Posted on: Sep 5 2018, 02:55 PM


Group: Member
Posts: 517

So, this is frustrating as all hell. So many, as usual, unanswered questions.

-Is it a formal RTF or not? We don't know.
-Or, has the application in fact been validated? Not clear, but it would appear not.
-Has the review "clock" started yet? Subject to the above my guess is no.
-How can this happen after such long-term intimate FDA contact? Well, apart from incomptence somewhere in "our" process I guess it's hard to say.

I get that the FDA might not have shared timelines to the PR decision once the inadeqacies are covered, but there is no acceptable excuse for not sharing with us timelines to submitting the relevant data. Heads should roll, but of course they won't since they like carrots but seem to be fresh out of sticks. Where is Wolgen in all this? It seems like he's terrified of putting his name to anything other than "Newsletters" these days - he's always putting up someone else to make the commentary. Very odd.

Having said all that, "product manufacturing information" and "details from the Europen post-authorisation use of Scenesse" sound, hopefully, easier to address than questions around efficacy or safety.

It's a bump in the road, but hopefully not a Blues Brothers style incomplete freeway.
  Forum: By Share Code

Frogster
Posted on: Sep 5 2018, 12:12 PM


Group: Member
Posts: 517

"Through diligence and integrity we advance and serve the people."
Is this becoming another countdown clock?
  Forum: By Share Code

Frogster
Posted on: Aug 31 2018, 05:07 PM


Group: Member
Posts: 517

Well, what a nice way to head into the weekend.
RC, if you still read this board, drop me an email at frogsterfrogsterfrogster@gmail.com please.
  Forum: By Share Code

Frogster
Posted on: Aug 30 2018, 10:09 AM


Group: Member
Posts: 517

You might be right ultimately - there's certainly no compelling operational reason to stay domiciled here. If our speculation about Blijdorp becoming chair is correct then 3 of 4 known directors themselves would be domiciled outside of Australia. Personally I'd expect any exit to be staged. I'm not sure CUV will ever be paying a fully fraked div anyway!
  Forum: By Share Code

Frogster
Posted on: Aug 30 2018, 09:49 AM


Group: Member
Posts: 517

Indicators from Clinuvel? Yes, most assuredly. See the post by Investek a page or so back, quoting the preliminary financial report.

What we now know is that a succesful listing on an overseas exchange is a bonus trigger for the CFO, with an execution date of 30/6/2019. If that date isn't met, then of course his bonus terms might be rolled over, but at the same time it hints something could happen in fairly short order.
Any NASDAQ listing would surely have ownership rights, and voting rights too in all probability. What would be the point of it otherwise? There'd be no real change from the current status quo otherwise. A NASDAQ listing would not neccesarily mean the CUV listing would disappear - dual listings are nothing unusual. I'd expect each shareholder would be given the option to keep current holdings/convert as they so desire. The paperwork would be trivial to the share registrars.

There could be a NASDAQ listing with no capital raise, but to me that would be a missed opportunity. From a post I made just over a year ago:

**********
https://listingcenter.nasdaq.com/assets/initialguide.pdf

Page 6 in here (from Jan 2017) suggests we'd fail to meet the criteria for the top tier NASDAQ Global Select Market, but p8 and p9 suggest we meet the Market Value Standard criteria for the second tier NASDAQ Global Market or the third tier NASDAQ Capital Market. Depending on the FY results in a few weeks, we might also meet the Income Standard for both these tiers very very soon. So, NASDAQ might work.

As we've discussed on here before (what seems like years ago.....), the following scenario once again looks plausible.

If management were able to go to the US as:

a) a cash generative, debt free, profitable company, with
b) a product already approved in the EU, and
c) a US NDA/approval for EPP in place/pending, looking for a
d) US listing alongside a capital raise, to fund
e) phase 3 US vitiligo trials, supported by
f) strong CUV103 trial results

then it could be a compelling story. As an aside, in just checking my notes from the last AGM, PW was asked about the possibility of a US listing. His answer suggested this was likely only if true corporate value was not reflected in the share price.
**********


List on NASDAQ and raise funds for phase 3 vitiligo trials is quite likely in my view. We still wouldn't meet the listing criteria for the Global Select Market (1 more year and we probably would), but I think we'd qualify on the Global Market and Capital Market tiers as of now.
  Forum: By Share Code

Frogster
Posted on: Aug 29 2018, 07:13 PM


Group: Member
Posts: 517

Totally.
Plenty of institutional fund investment mandates require that investments are only made in dividend paying shares.
  Forum: By Share Code

Frogster
Posted on: Aug 29 2018, 05:43 PM


Group: Member
Posts: 517

Interesting that there is, for the first time, an introduction to the remuneration report by the chair of the remuneration committee - Mr
Blijdorp. The text is below.

I wonder why they might do this? Is it an attempt to "introduce" him and his thinking to us ahead of Stan steping down within the year? It strikes me as unusual to go into his thinking in as much detail as they have without some objective behind it. Blijdorp for Chairman seems quite likely to me.
In terms of content, it's interesting that he likes companies he's involved in to have up to 20% of equity in executive management hands. Also he want PW to stick around through to 2021. Also, he hopes to announce a new contract for PW before year end.
I think that means we can expect PW to be offered another chunky share package at the AGM.



INTRODUCTION BY THE CHAIR OF THE REMUNERATION COMMITTEEChairman of the Remuneration Committee: Mr Willem Blijdorp
“I regard my duties as Chairman of the Remuneration Committee as paramount to the wellbeing and longevity of the CLINUVEL group. From the current position of the Company it is imperative for me and my fellow Board members to look ahead and plan for the next few years for the Company to grow and thrive further.
In providing the objectives of the Remuneration Committee and its approach to executive remuneration, I briefly share my professional background and outlook which has taken me where I am professionally today.
As Chair of the Dutch-publicly listed B&S International, a global leader in trading and logistics, I am used to operating in markets which are often tested by changing legislation, new tariffs and where pressure on pricing is experienced. To navigate these challenges, I have always chosen the most successful leadership teams based on a set of fixed criteria. In my opinion, company executives need to demonstrate strong leadership skills, have an ability to roll up their sleeves, and be able to articulate to the Board of
Directors periodically their realistic vision for the company for the years ahead.
Above all, I regard the success of a company as a direct reflection of the intelligence, insistence and integrity of the management teams. In this sense, the key management personnel and the company executives can make or break a company, seldom its services or products, and it is the daily quality of the managerial decisions made by the top people at the helm which matter, nothing less in my books.
In addition, I want to see in the executive management in all companies with which I involve myself to have a sizable ownership by executive management – in cases up to 20% – to make sure that their objectives are aligned with the 80% owned by other shareholders. This approach has provided me and my shareholders the success I enjoy today, and as Chairman of the Remuneration Committee I am supporting the same criterion when it comes to CLINUVEL’s leadership team.
In line with the objectives set by CLINUVEL’s Board of Directors, the task of the Remuneration Committee, as explained in greater detail in this Remuneration Report is to:
1. secure the services of excelling management;
2. align the key performance indicators of executive management with those objectives set for the group of companies;
3. evaluate the performance of executive management against
a) internal performance criterion;
b) international benchmarks in context of this sector;
4. strive for business continuation and sustainability through retention of staff.

I use this very approach also to assess the attitude and performance of the CLINUVEL key management personnel and its company executives with an eye to grow the Group in the coming period. In July 2018, I invested significant sums of my own capital in CLINUVEL, I have a clear interest to continue the success story of this biotechnology venture.
In all the conglomerate of business enterprises I lead, my motto has remained simple: “people work for people”, and this holds true for Dr Wolgen and the team around him. In order to succeed in markets where great challenges are expected and met, you need in business execution what I call “eccentric leadership”. In Dr Wolgen we have this and it needs to continue for another three years, through to 2021, to meet all CLINUVEL’s objectives. While I am certain others could do the job, in my position as Head of the Remuneration Committee, I wish to see continuity for the next term, focus to be sustained, meaning zero distraction from the end game.
What is said about the CEO also goes for the steady and reliable financial management by the CFO in overseeing the Group of six companies globally and containing the Company’s management of costs. The profitability of CLINUVEL is largely owed to the work of Mr Keamy, hence our strong wish to prolong the CFO-CEO axis.
Lastly, we have agreed that the Acting CSO, Dr Wright, will remain as key management personnel while training and providing a basis for succession planning of the next generation of scientific management.
Overall, as Chair of the Remuneration Committee I make a periodic assessment of the operations of the Group. In this sense, I do wish to see continuation and no disruption to the CLINUVEL business to maintain enterprise value at a time where the US market beckons, European distribution grows, new products advance, and the growth of managerial talent is taking place under the leadership of the Managing Director.
Since initially attending a CLINUVEL shareholder meeting in Melbourne in early 2006 I have witnessed – first from distance, and since 2015 as a Board member – how this Company has plotted and manoeuvred around buoys along its voyage.
At multiple cross-roads the Board of Directors has had the choice to intervene or take a more passive attitude towards top management when it came to decisions such as opting to license out the lead technology, sell it off early, or retain it to develop it to today’s success. Other key decisions involved, for example, the financial management of the Group, whether to make larger investments in R&D, pursue multiple indications at the same time with one or several technologies, and raise more capital. As a Non-Executive Board member I have an advisory role but am personally more in favour of steadily building the Company and staying in control of our own destiny. While I try to share my strategic vision with current management of CLINUVEL I stay away from imposing too strong views, however I am extremely content with the way we perform.
The quality of CLINUVEL’s decisions rested on the depth of analyses of the executive management teams giving me and my fellow Board members the confidence that CLINUVEL would navigate and sail around obstacles to make the Company profitable and sustainable. This is the place where we are today.
As Chair of the Remuneration Committee I focus on corporate results and the Company’s ability to meet the short- and mid-term objectives that are within management’s reach.
The short-term objectives are found in the key performance indicators (KPIs) set for all personnel, and in more specific terms in those of the other executive Key Management Personnel including the CEO. Several of these KPI’s are commercially confidential in nature in an attempt to stay ahead of possible competitors, other indicators are more tailored to general business objectives. The mid-term objectives are directly related to the Group’s objectives to achieve profitability and sustainability, and are captured in Business Generation Incentives.
In my view, the current successes of CLINUVEL are assigned to the vision, leadership and execution of the current management team headed by our CEO and CFO who are responsible for the financial discipline which has led to today’s profitability.
The Company’s mid-term vision is found back in its “2020 CUV Strategy” explained in the 2017 AGM presentation and it provides this Committee with a framework for the corporate objectives for the foreseeable future. Accordingly, these objectives are reflected in the remuneration packages of the Managing Director, CFO, Acting CSO and in the future of other executive Key Management Personnel to be recruited.
In arriving at the executive remuneration packages, we strive to provide overall incentives that secure continuation and no disruption of the business at this critical stage of CLINUVEL. The Committee assesses the criticality of CLINUVEL’s business operations based on the following corporate milestones:
1. US regulatory clearance for SCENESSE®
2. US market entry & distribution of SCENESSE®
3. Continuing successful distribution of SCENESSE® throughout the Europe Union
4. Establishing a European business unit by March 2019 (post-Brexit)
5. New product development of
a) VLRX001, CUV9900
b) complementary OTC
6. Expansion of the CLINUVEL Group.
As the Chair of the Board of Directors Mr McLiesh stated earlier this year in his ‘Chair Letter’, our immediate task is to finalise a new employment agreement with the Managing Director. I hope to be able to report on these agreements by the end of this calendar year.
Herewith, I recommend CLINUVEL’s shareholders the remuneration incentives offered to the key management personnel.”
  Forum: By Share Code

Frogster
Posted on: Aug 14 2018, 02:12 PM


Group: Member
Posts: 517

Over the years of being long CUV I've often wondered just how significant our collective tendancy to masochism is.
I guess it's a spectrum.
biggrin.gif .
  Forum: By Share Code

Frogster
Posted on: Aug 11 2018, 03:41 PM


Group: Member
Posts: 517

By Farmazutical, from March:

New indication:
I agree with Uho who recently posted on GG that, logically,
the new orphan indication for Scenesse could be XP.
There is no cure for the condition and absolute sun avoidance
is one of the ways to live with XP. Although there are a few known cases
of XP in Fitzpatrick 5 it’s predominantly a condition that affects
lighter skin types. The pathology is different but there are many
similarities with porphyria. Scenesse’s DNA repairing, anti-inflammatory
and melanogenetic properties could very well
alleviate many of the symptoms in XP.

Clinuvel stated recently, that they are seeking regulatory
approval for EPP in Australia and Japan in H2 2018 following
submission of the NDA in the US.

Prevalence of EPP is the same in Japan as in most Western countries.
With a population of 127 million people we can expect <500 EPP patients
in Japan.

XP, however, has a prevalence of 1:20.000 in Japan resulting in
more than 6000 XP cases in that country alone. It makes sense to approach
Japan for EPP with the scope of gaining a label extension approval
for XP shortly after.


Kudos to Farma and Uho. Looks like you could well be right.
  Forum: By Share Code

Frogster
Posted on: Aug 9 2018, 02:37 PM


Group: Member
Posts: 517

I guess we'll get to see just how much real intent there is to pay more heed to the patient voice. There's been alot of talk about it. Let's hope the practice and reality stacks up.
  Forum: By Share Code

Frogster
Posted on: Aug 9 2018, 07:08 AM


Group: Member
Posts: 517

I hope it makes them feel a whole lot better as I can't see it helps the appeal process very much.
  Forum: By Share Code

Frogster
Posted on: Jul 27 2018, 09:59 AM


Group: Member
Posts: 517

http://www.clinuvel.com/investors/news/announcements

Newsletter out.
Not terribly exciting content.
:FDA application......it was a big dossier.....well done all
:Pharmacovigilance.....implant design was important to control distribution channels
:Brexit.....we don't want to have to move from the UK
:Expansion.....product line underway. No substantial detail on launch of new product line (July looking less and less likely!), CUV103 results expected sometime (really?? been expected for about 4 years now!!!), US vitiligo trial depends on US EPP review.
  Forum: By Share Code

Frogster
Posted on: Jul 26 2018, 01:52 PM


Group: Member
Posts: 517

We're probably all expecting Clinuvel will announce record quarterly receipts from customers in the next few working days via the 4C quarterly report for entities subject to Listing Rule 4.7B. Does anyone know for sure that they will do this?

By this, I mean release a 4C. I'm certainly expecting the receipts would be a record, but I'm not sure they'll have to release the document.

ASX Listing rule 4.7B is basically a rule that applies to companies with similar cash flow characteristics to oil or mining exploration companies, before they become oil or mining production companies. i.e. the rule provides for enhanced cash flow reporting whilst entities are consumers rather than generators of cash. When companies have changed the nature of their operation to become cash generative, the need to report a 4C drops away.

ASX listing rule Guidance Note 23 (p8, link below) states:
"As a general rule, ASX usually likes to see at least 4 consecutive quarters of positive net operating cash flows before it will lift the requirement for an entity to provide quarterly cash flow reports under Listing Rule 4.7B. To that end:

an entity whose last 4 quarterly reports have all reported positive net operating cash flows will not usually be required by ASX to continue any further quarterly cash flow reports;"

So, as we know, CUV has been net cash generative for the last 4 consecutive reported quarters (bet they squeezed things real hard last quarter to make this happen) and may no longer have the requirement to issue a 4C. The decision to lift the requirement does not appear to be an automatic right, but rather the ASX has the discretion to ask for more 4Cs if it sees fit. Their reporting calender on the Financial Overview page on the website still lists a Q2 4C as due no later than 31 July, but they're usually pretty slack in keeping this page up to date and accurate. I've asked them (CUV) for clarification but as we know they don't often like to engage with us on these matters.


So, I wouldn't be surprised to NOT see a 4C this month, and that means the next results due would be H1 figures due by end August. Of course, before then, we may yet see an announcement on the fabled new product line (states as "expected to be announced in July 2018 following the completion of the NDA submission", and of course we can hope for validation of the NDA on 22 August (4 weeks yesterday).


So let's wait and see what happens, but some advance clarification would be nice. Essentially, if no 4C emerges by close on Tuesday it's not neccesarily a cause for panic!


P.S. Kudos to the member on here who sparked me into looking this up.


https://www.asx.com.au/documents/rules/gn23_appendix_4c.pdf
  Forum: By Share Code

Frogster
Posted on: Jul 7 2018, 02:23 PM


Group: Member
Posts: 517

I'm not sure I'm any more qualified to comment here than anyone else, but I've been involved in a few block trades over the years and my speculation on what's happened is as follows:

-block trades are used to shift sizeable positions with minimal market impact. Imagine trying to sell 1.3m CUV on the market! That would be a LOT of average trading volumes days and would doubtless have a substantial negative impact on the price of a very thinly traded stock. The 10% discount to market is what the seller has accepted to mitigate the very real chance that selling piecemeal would drive the stock significantly lower. I don't think the $10 would have been agreed long ago and that this was a long planned trade between 2 known parties, I just think it nicely fits the current interests of both parties. On balance Lagoda has judged it's interests are better served by selling at -10% in one hit rather than being every share on the sell side for a solid 65+ days or trading.


-block trades are usually negotiated at arms length. It's more usual for the buyer to know who the seller is (cause the shares can only come from a holder in size, but anyone can be the buyer) than vice versa. That doesn't mean the seller would never know who the buyer is, but in my experience they may well not. It's not clear to me if this was done through a service like Centrpoint as described by Johnny H, or if it would have been put together the old fashioned way, through networks and contacts. I would speculate the latter, and I wouldn't be surprised if Lagoda got in touch with Stan or the Walnut directly and asked if they knew of any party interested in buying in size......and as it happens it appears they did.


-Why sell now from Lagoda's POV? Obvioulsy could be very many reasons, but I think MrDax is probably right that a big speculative overweight position taken out years ago has just been getting bigger and bigger as the stock has climbed from the $2ish they started buying at to the $11ish of today. A PM has to managed their risk profile, so why not unload a huge heap of risk and lock in a great profit? I don't know what their average cost price was, and I'd guess they're not in a free carry position for their remaining holding, but they have enormously derisked their position. If you are a sizeable holder of stock, you've got to have an exit strategy, and I wonder if the NDA was a pre identified trigger for Lagoda to rebalance. Will be interesting to see if they keep hold of the smaller stake, or if they want to seel a few more.

-the trade was concluded in a closed period, but it was started before the period began. Blijdorp was given permission to conclude a trade in the closed period by applying to do so on 28/6/18. I don't think he knows FDA approval will be given - if he did that would surely be insider trading and for the same reason he probably doesn't have even provisional year end financial data - but clearly has a positive expecation for the company for years to come. I find that very comforting.

So, overall, my speculation is something along the following lines happened: NDA was submitted. Lagoda recognised that as a trigger to rebalance, lock in a profit and derisk. They called Stan to ask if he knew anyone interested in buying a block. Stan said let me check....he asked PW.....who said "Hey, I just might......give us a few days....." After a few days PW replied to Lagoda "Yup....we've got you a counterparty who'll take 1.4m at $9." Lagoda squeezed them up to $10....and the paperowk was finallised in the closed period with CUV ethics committee approval. My guess would be that Lagoda only found out who the buyer was later......but they don't care cause a Director spending that much of his own cash is a tremendous signal for a stock that they still have a big exposure to.
So, that's my speculation....it's a story that for me fits....but I guess we'll never know the facts.
  Forum: By Share Code

Frogster
Posted on: Jul 6 2018, 03:18 PM


Group: Member
Posts: 517

That is very good to hear!
  Forum: By Share Code

Frogster
Posted on: Jul 4 2018, 03:22 PM


Group: Member
Posts: 517

Yep. And to think they started buying in size at A$2 (or thereabouts).
I wonder if we'll see the other side of the trade. That would be fascinating.
  Forum: By Share Code

Frogster
Posted on: Jun 25 2018, 06:44 PM


Group: Member
Posts: 517

Thank you mrdax. I'm on my phone and doing that myself was just too hard.
  Forum: By Share Code

Frogster
Posted on: Jun 25 2018, 06:17 PM


Group: Member
Posts: 517

Royco, search my past posts for data on how long its taken in the past for performance rights shares to be issued after meeting a performance condition. From memory its been between a week and a couple of months. There's nothing sinister or unusual in the fact that its not been announced yet.
  Forum: By Share Code

Frogster
Posted on: Jun 25 2018, 10:36 AM


Group: Member
Posts: 517

Congratulations to management.

They have variously come in for lots of criticism from many of us, myself included, and they sure have deserved much of it. Having said that, they have today announced something pretty remarkable. One thing we have never criticised them for is their tenacity. That's on show today in spades.

Whilst there's still a long and challenging path ahead, today is a good day.

Well done Dr Wolgen and team.
  Forum: By Share Code

Frogster
Posted on: Jun 25 2018, 09:55 AM


Group: Member
Posts: 517

Duplicate. Tooooooo sloooooooowwwwww.
Attached File(s)
Attached File  43w0mgrl4csb10_1_.pdf ( 373.73K ) Number of downloads: 37

 
  Forum: By Share Code

Frogster
Posted on: Jun 24 2018, 02:13 PM


Group: Member
Posts: 517

Remember that 924,974 number is the total of performance rights that he holds. They convert to shares on a variety of milestones.

The single biggest one is the SUBMISSION (Seeva) of the marketing application to the FDA. It's a pretty sweet hurdle. Submission only. Not triggered by actual approval or anything commercially important like that.

This is Performance Condition 4 of the scheme that was put to shareholders at the 2014 AGM. You can read the exact phrasing in the AGM explanatory notes. The scheme was renewed at a more recent AGM (last year?). Triggering PC4 nets PW 624,975 shares.

Stan will get 25k shares, same for Brenda and Elie would've got 17.5k.

I'm not sure what the specific events are that'll get Wolgen his remaining 299,999. Strange number that.
  Forum: By Share Code

Frogster
Posted on: Jun 24 2018, 12:33 PM


Group: Member
Posts: 517

He wont be getting 5m shares. It's something like 624k shares from memory on submission of the NDA.
3 of the other directors will get a much lower number of shares on submission.
Some of the management will get shares on approval of the application, but the quatum hasn't been published.
There's a huge difference between a trading halt around a capital raising, and the issuance if shares to action an approved reward scheme. I'd be surprised if you ever get a halt for the latter.

If share issuance is involved in this event, it's a secondary item to the regulatory submission.
  Forum: By Share Code

Frogster
Posted on: Jun 23 2018, 04:34 PM


Group: Member
Posts: 517

I found myself wondering in the middle of last night why trade would be halted in Australia and Germany but not in the US?
We know CUV hasn't always dotted every i and crossed every t, but to forget to request a halt would surely be beyond the pale.
Anyway, I did some digging and found the following. It's not that enlightening about the core issue, but it answers some questions I had.

- Clinuvel trades OTC in the US as a Level 1 ADR. It's not an exchange listed security.

- The ADR agreement between Clinuvel and BNY Mellon makes no mention of Trading Halts and how they should be handled.

- According to this page, OTC traded products are regulated by the SEC and FINRA and only they can halt or suspend trading in stocks (I think Johnny H mentioned this a few days back) https://www.otcmarkets.com/learn/faqs

- According to this SEC pdf, https://www.sec.gov/investor/alerts/tradingsuspensions.pdf the SEC will only suspend trading to protect investors and the public interest when there are questions around things like failing to file periodic reports, allegations of insider trading and accuracy of finanial reporting. So, a regulatory submission wouldn't get the SEC to raise an eyebrow.

- According to FINRA, as per this page, http://www.finra.org/industry/faq-otcbb-fr...d-questions#700 FINRA will halt trading of an OTC ADR if trading in the foreign exchange is halted for "public interest concerns" but "FINRA will not impose a trading and quotation halt if the Foreign Regulatory Halt was imposed solely for material news, a regulatory filing deficiency, or operational reasons". So material or operational news will not be enough for FINRA to halt trading on CUV ADRs.

This all tells us nothing about what the underlying reason for the Aus trading halt is, other than to say it's probably material news. What is does suggest is that each exchange/body has appropriately applied it's own differing rules, and that there's no failing by CUV in this.

Personally I think the news in question is simply that the NDA is finally lodged and that some kind of timing issue meant they couldn't announce to the ASX on Friday. I'm imagining a scenario where the submission was completed late Thursday US time, and confirmation wasn't received till Friday in the US, which was too late to publish when the ASX was open. For some reason they thought the news might leak, so they chose the halt to be certain trading wasn't misinformed. If it was something like an RTF, surely an instant ASX release would have been required, in the same way that they were very swift to inform recently of the unhelpful developments at NICE. I guess we'll find out soon enough.

GLTA.
  Forum: By Share Code

Frogster
Posted on: Jun 22 2018, 01:41 PM


Group: Member
Posts: 517

Something along those lines makes sense to me.
  Forum: By Share Code

Frogster
Posted on: Jun 22 2018, 01:28 PM


Group: Member
Posts: 517

Is anyone else feeling a little distracted from whatever else they should be doing today?
  Forum: By Share Code

Frogster
Posted on: Jun 22 2018, 10:12 AM


Group: Member
Posts: 517

Yes, it's re "regulatory submission"


Attached File(s)
Attached File  43vz4mf92z60zj_6_.pdf ( 235.37K ) Number of downloads: 163

 
  Forum: By Share Code

Frogster
Posted on: Jun 22 2018, 10:07 AM


Group: Member
Posts: 517

Ooooh.
Trading Halt.
  Forum: By Share Code

Frogster
Posted on: Jun 21 2018, 12:56 PM


Group: Member
Posts: 517

Lol.
Demonstrable protection from the shell too!
  Forum: By Share Code

Frogster
Posted on: Jun 21 2018, 12:40 PM


Group: Member
Posts: 517

I'm imagining Frilly is infact still on the scene, only he's been reassigned.
He's no longer the frontman.
He's delivering the NDA to the FDA. On foot. One page at a time. And eating a few along the way. Probably.
  Forum: By Share Code

Frogster
Posted on: Jun 17 2018, 12:50 PM


Group: Member
Posts: 517

Not sure this update (or rehash) from Friday has been posted here:

https://simplywall.st/stocks/au/pharmaceuti...limited-asxcuv/

and their company report:


https://simplywall.st/stocks/au/pharmaceuti...utm_source=post

This includes a DCF derived target price A$54.61.

I'm not a subscriber to Simply Wall St and I haven't looked at their assumptions in detail but the target price sure is worth thinking about.
  Forum: By Share Code

Frogster
Posted on: Jun 15 2018, 04:45 PM


Group: Member
Posts: 517

That high?In that case I'm doubling up first thing Monday! rolleyes.gif
  Forum: By Share Code

Frogster
Posted on: Jun 15 2018, 04:17 PM


Group: Member
Posts: 517

10 trading days left till the end of June.
Will they/won't they submit within their latest deadline?
Fingers crossed they finally mange it.
  Forum: By Share Code

Frogster
Posted on: Jun 4 2018, 06:00 PM


Group: Member
Posts: 517

Funny? Yes.................but it's Clinuvel.
As to the revenue trigger, I think you might be assuming that all group revenues are made under the EMA, and I don't think that's the case. Special access schemes are not included under the umbrella of the EMA.

Revenues listed under the "Sales reimbursements" P&L line item are the revenues from the Swiss and Italian special access schemes which have been running for some time (though the Italian SAS ended in 31/8/16).
Those listed under "Commercial sales" are those made under the EMA approval (to the Netherlands, Germany, Austria and, since 1/9/2016, Italy), and these have only been generated since the first commercial sale was announced on 21 June 2016.
  Forum: By Share Code

Frogster
Posted on: Jun 4 2018, 11:56 AM


Group: Member
Posts: 517

Minus Sinus, I don't think this means they have changed the terms of the award for Directors. I believe what this shows is that Directors will get their big slug of shares on submission of the dossier as before, but that executives and other staff will get some shares when approval is granted. They've combined in this list the conditions attached to different schemes pertaining to different levels of function, and not all conditions apply to all schemes. That's why condition B says "not attached to Non-Executive Directors" i.e. it's not a condition that applies to their award.
My guess is that this share issuance is triggered by condition E or F.
The recent regulatory update stated Vallaurix is "working to establish an appropriate formulation of afamelanotide", so it could be that.
As for the 10m figure, the trigger is EURO 10m, not A$. In 16/17 commercial sales, which I'd interpret as those made under the EMA approval (as opposed to under other special access schemes), were A$11.9m which is approximately Euro 7.7m. With growth into the current season that Euro 10m hurdle could now have been breached but I'm not sure it previoulsy would have been.
  Forum: By Share Code

Frogster
Posted on: May 29 2018, 09:23 PM


Group: Member
Posts: 517

http://www.clinuvel.com/social-media/subq/such-tweet-sorrow

Are anyone's ears burning?
  Forum: By Share Code

Frogster
Posted on: May 29 2018, 04:35 PM


Group: Member
Posts: 517

Hi Stan,
Could you give us that in German, Swahili, or perhaps Latin please?
TYVM.
  Forum: By Share Code

Frogster
Posted on: May 25 2018, 11:54 AM


Group: Member
Posts: 517

Clinuvel promised 3 scientific communiques in April and May.
Only 1 published so far. May is obviously not over yet, but it's cutting it a bit fine.
I wonder if they will be delayed along with/because of the NDA and topical launch?
  Forum: By Share Code

Frogster
Posted on: May 17 2018, 12:15 PM


Group: Member
Posts: 517

http://www.aspecthuntley.com.au/docserver/...&popup=true

Lagoda must have thought so too.

Turns out they've been selling in dribs and drabs since November 2017.

Who's doing the buying?

German retail spruiked by Mr Homm?
New insto?

Interesting times.
  Forum: By Share Code

Frogster
Posted on: May 16 2018, 12:33 PM


Group: Member
Posts: 517

p41 of the AGM slides indicates Q3 Asian "Launch CLINUVEL skincare solutions 2 distribution channels" which - hopefully - does actually relate to an actual commercial launch of an actual product. Actually.

You may very well be wise in taking a low expectation view, but if this "launch" isn't in fact a launch, then we'll have another example of failed communications to gripe about. I hope we don't get another. We already have enough I think.
  Forum: By Share Code

Frogster
Posted on: May 14 2018, 01:36 PM


Group: Member
Posts: 517

My guess is the work experience lad can't cope with writing 2 press releases at a time.
  Forum: By Share Code

Frogster
Posted on: May 14 2018, 08:36 AM


Group: Member
Posts: 517

NDA expected before 1 July 2018.

Safety data all good.

Haven't read the rest yet.

Have read it now:

5100+ implants
4000+ implants to EPP patients
99% patients remain on treatment
Latest PSUR raised no new safety issues
No off label use has occured - the controlled distribution works
Some Swiss patients have had over 50 implants over 12 years
New saftey data is now incorporated in the NDA, with final submission of the dossier expected before 1/7/2018
First complemenatary non-prescription products/follow on products due to be announced in July following the NDA (I guess 20 May no longer applies)
Work on paediatric Scenesse is underway.
Attached File(s)
Attached File  01980973.pdf ( 97.21K ) Number of downloads: 113

 
  Forum: By Share Code

Frogster
Posted on: May 12 2018, 06:59 PM


Group: Member
Posts: 517

Did the walnut not say by (not on) the 20th? Can't check right now, but that's what i recall.
  Forum: By Share Code

Frogster
Posted on: May 11 2018, 07:38 PM


Group: Member
Posts: 517

It sounds somewhat unethical to me.
  Forum: By Share Code

Frogster
Posted on: May 1 2018, 01:59 PM


Group: Member
Posts: 517

Maybe it looks a bit low on the face of it but you wouldn't take shares, presumably with some lock up agreement, unless you thought they were going to be worth more at and beyond the point the lock up expires.

A typical lock up period might be a year. A lot of good stuff is widely expected to happen in that time frame.

Equally, if you thought a lot of bad stuff was going to happen in that time you probably wouldn't take shares would you?

I'd expect Biotech Lab to be better informed of what's going on on the inside than any of us here.
  Forum: By Share Code

Frogster
Posted on: Apr 30 2018, 11:25 AM


Group: Member
Posts: 517

FWIW my thoughts are that for the weakest seasonal quarter, these are a decent set of figures. I was expecting slightly negative cash flow (-A$720k) so to see them generate A$230k from operations is pleasing Cash generateive all year round? I like that.

Virtually all of the uplift came from Receipts being better than I'd anticipated (A$3480k reported vs A$2500k expected). A fairly big FX effect obviously flattered the cash balance, but there's little you can do to control that inthe long term.

Other points I thought were interesting:

- Q4 Advertising spend antcipated to be 2nd highest in their history
- Product manufacturing costs expected to set a new high in Q4, having today set one in Q3
- Staff costs in Q4 are expected to remain high af A$1640k. That would be the 2nd highest quarter in Clinuvel history (the highest being Q1 this year). Q1 is normally high due to bonuses, so I wonder if Q4 is related to staffing up, or a continuation of the highish level seen this quarter (long term personnel related payments)
- Can't remember the CFO ever making a statement on the 4C before. I'm pleased to see they are beginning to discuss things a little more than they used to.
- "developing and delivering treatments for patients with a RANGE of severe genetic disorders" Mmmmm. Expansion.

Obviously the top line isn't going to grow dramatically till more markets come on line (especially the US) but as the company works towards that goal, these strike me as a pretty reasonable set of figures.
  Forum: By Share Code

Frogster
Posted on: Apr 22 2018, 12:56 PM


Group: Member
Posts: 517

Clinuvel has only ever referred to the figure in that classy new logo as Diana.

Diana (daughter of Jupiter and Latona) was a Roman goddess, whilst Artemis (daughter of Zeus and Leto) was the Greek version of a similar character. I guess whether they actually can be coinsidered as interchangeable depends on whether you are Greek or Italian (then probably no) or from elsewhere (then probably yes).

Would it therefore be inconsistent to trumpet Diana in the logo, then expand a product line under Artemis branding? In my opinion, probably yes. Would this worry Clinuvel? In my opinion probably no - I don't think they thought that deeply about the rebrand in general, so if they didn't think about this aspect either I wouldn't be surprised.

Anyway, maybe that's enough moaning about the logo and perhaps it's time to enjoy the recent share price action instead.
  Forum: By Share Code

Frogster
Posted on: Apr 17 2018, 11:57 AM


Group: Member
Posts: 517

At least they've dropped the Latin in the motto on the instagram channel.
  Forum: By Share Code

Frogster
Posted on: Apr 6 2018, 03:36 PM


Group: Member
Posts: 517

You may well be right, but my guess is that this was done by the current graduate trainee.
  Forum: By Share Code

Frogster
Posted on: Apr 6 2018, 01:55 PM


Group: Member
Posts: 517

What a great way to attract long-term fundamental investors by making the first analyst report you publicise in 5 years one where fundamentals are barely mentioned, fair value isn't discussed at all and the entire research theme is based on stoking speculative takeover froth!

On the one hand I'm pleased to see the company crank up the communication efforts a little. On the other it's really disappointing to see they still have the learner wheels well and truly bolted in place.
  Forum: By Share Code

Frogster
Posted on: Apr 5 2018, 06:30 PM


Group: Member
Posts: 517

Indeed there was. From 8/3:


Just for reference:

Performance Condition 1 was met on 28/11/14, and the 3B (New issuance) and 3Y (Change in Directors interest) notices were issued on 4/12/14 i.e. 6 days

Performance Condition 2 was announced as met on 23/12/14 and the 3B and 3Y notices were issued on 23/1/15 i.e. 31 days

Performance Condition 3 was announced as met on 22/6/16 and the 3B and 3Y notices were issued on 4/8/16 and 5/8/16, i.e. 47/48 days

If history is any kind of guide, when Performance Condition 4 is met, it might be 1 to 7 weeks before the statutory ASX announcement is made.
  Forum: By Share Code

Frogster
Posted on: Mar 24 2018, 10:45 AM


Group: Member
Posts: 517

I'm not so sure.

The minutes of the meeting held 14/2 refer to the IR panel convened on 23/1, the outcome of which would be presented at the next meeting (to be held on 14/3).

Seems to me that the 22/3 Welsh government ratification of the recommendation not to use in NHS Wales was made after the IR panel result was presented last week.

If this really is the final word in Wales (at this stage) it's not pleasing, but probably not that surprising either. It just reinforces that FDA approval is the critical factor right now.
  Forum: By Share Code

Frogster
Posted on: Mar 19 2018, 09:27 AM


Group: Member
Posts: 517

In the AGM presentation, on page 40, the EPP expert meeting SCENESSE evaluation was listed as the 3rd European & Australian milestone for the year. To my eye the data point sat in roughly April/May, so it appears to have happened early.

p40 of the same presentation showed that the FDA decision on Priority Review should occur almost simultaneously with the expert meeting.

Whether or not this is significant depends, I guess, on your view as to why the expert meeting seems early: genuinely brought forward? AGM timelines intentionally inaccurate/indicative only? Can you draw parallels between the regional milestones at all?

Anyway, time will tell, but it's good to see stuff happening broadly as planned this year.

EDIT: I think my post ties in with ajshare's comment. Reporting on the PASS data is only supposed to happen after the final FDA module is submitted. Looks to me like the NDA is done. New shares for PW soon?
  Forum: By Share Code

Frogster
Posted on: Mar 19 2018, 09:05 AM


Group: Member
Posts: 517

http://www.aspecthuntley.com.au/docserver/...&popup=true
  Forum: By Share Code

Frogster
Posted on: Mar 16 2018, 03:29 PM


Group: Member
Posts: 517

Nice finish to the week.

Last time we had volumes like this for a few days was back in November when the share blew through 7.00 and went on to 8.50 in short order and peaked a little over 9.00.

I wonder if we have a case of bigfigureitis?
  Forum: By Share Code

Frogster
Posted on: Mar 8 2018, 08:42 AM


Group: Member
Posts: 517

Just for reference:

Performance Condition 1 was met on 28/11/14, and the 3B (New issuance) and 3Y (Change in Directors interest) notices were issued on 4/12/14 i.e. 6 days

Performance Condition 2 was announced as met on 23/12/14 and the 3B and 3Y notices were issued on 23/1/15 i.e. 31 days

Performance Condition 3 was announced as met on 22/6/16 and the 3B and 3Y notices were issued on 4/8/16 and 5/8/16, i.e. 47/48 days

If history is any kind of guide, when Performance Condition 4 is met, it might be 1 to 7 weeks before the statutory ASX announcement is made.
  Forum: By Share Code

Frogster
Posted on: Mar 2 2018, 06:47 AM


Group: Member
Posts: 517

624,975 shares to Wolgen + circa 65k to the rest of the board.

Page 21 of the attached document.

Details announced on day of EMA approval 27/10/2014.
Attached File(s)
Attached File  CUV_Notice_of_Annual_General_Meeting_Proxy_Form.pdf ( 665.02K ) Number of downloads: 61

 
  Forum: By Share Code

Frogster
Posted on: Feb 21 2018, 01:24 PM


Group: Member
Posts: 517

So it seems that the logo and the motto have, generally, gone down like a bucket or warm sick with those of us who've expressed an opinion. I'm guessing that we are, on the whole, offering our views as human products of Western economies and cultures. I'm wondering if the branding that is so jarring with us is, infact, designed to target another region?

We know that in the next few months we're expecting to finally get the CUV103 results (around April), focused on an Asian phenotype. We're also expecting to see details of the complementary product lines and markets served (May 20), the launch of the Analytical Lab in Singapore (around June), and the actual launch of the skincare solutions range in Asia (around Aug).

So, maybe, we're witnessing a pivot to Asia? Maybe Europe/US is just too hard? Maybe the logo is designed to capture the imagination of, say, the Chinese market? I don't know, but maybe Asians have a different response to logo graphics than we've mostly had. Does anyone have any views/experience of that? Do Asians seek different visual clues from a logo to Westerners? Perhaps the Southern Cross was included to emphasis the Australian origin of whatever products come to market and as we know in some product areas (i.e. baby formula) the Chinese seem to perceive Australian product as quality. Wild speculation on my part, but who knows?

If this is the case then it begs the question of what are the implications of turning a cold shoulder to Western sensitivities, but that's a question for another day I think.

Another thing that might possibly fit the framework is this Giles Delaney column thing. Apparently he's worked for papers and mags in Asia Pacific for 30 years. I've tried to do the normal searches you do for people these days, and I can't find any details on him or his experience whatsoever. Has anyone else been able to establish his credentials? I'd love to know the terms of his engagement. Editorial freedom yet his only contact point is a Clinuvel email? Seems like an unusual arrangement.
  Forum: By Share Code

Frogster
Posted on: Feb 20 2018, 07:06 PM


Group: Member
Posts: 517

I'm hoping this is simply a mechanism to prove they act on their Values statement.

Under Approach they state "We admit errors recognise our shortfalls, evaluate, analyse and learn to implement new findings."

Next week they're going to bin that graphical mess, roll out a decent new one and say "See, told you so", aren't they? Aren't they???


  Forum: By Share Code

Frogster
Posted on: Feb 20 2018, 05:45 PM


Group: Member
Posts: 517

Clinhope, the motto is at the bottom of EVERY page on the website.
  Forum: By Share Code

Frogster
Posted on: Feb 20 2018, 04:19 PM


Group: Member
Posts: 517

Since we can see the Southern Cross constellation in the logo, we can assume that the goddess of the moon is hunting at night.

What's a frilled lizard doing out at night? They're diurnal - they are not active at night.

Doesn't that send the message if you take our products you can go out at night? Shouldn't it send some kind of message that you can go out in the day? That you get protection from the sun? Why does Clinuvel want to be associated with the moon and the stars. Don't EPP patients want to get away from living a nocturnal existence?

Beyond it just looking amateur, isn't there a massive logical flaw in this combination of characters?
  Forum: By Share Code

Frogster
Posted on: Feb 20 2018, 12:54 PM


Group: Member
Posts: 517

Guys, guys, guys.....forget the lousy logo.......we've got a motto IN LATIN!!!

Nothing says disruptive, forward looking, innovative, technology led growth company than a motto.....on every page of the website......IN LATIN!!!


/I used to think it'd be a shame to see the company taken over. I'm beginning to think it'd be more of a mercy killing now.
  Forum: By Share Code

Frogster
Posted on: Feb 20 2018, 11:42 AM


Group: Member
Posts: 517

Yep.....kudos to you Investek for finding the Artemis/Diana website and link back in October. My, they must have been spitting feathers after you hit the Submit Post button.

I agree about the logo. Diana, frill neck lizard, AND the Southern Cross. Way busy.

A quick review of the site shows much of the same content as before. A few new bits here and there. I thought this was interesting:

http://clinuvel.com/social-media/monthly-viewpoints

It's a page where the journalist Giles Delaney wrote a column about branding. Apparently it will be monthly column:


"*This is the first column in a regular series about the big issues that affect CLINUVEL and the broader biopharmaceutical sector.

Giles Delaney is an experienced business journalist, having worked for newspapers and magazines in the Asia Pacific for more than three decades. As a guest writer, Delaney retains full editorial freedom and his views are his own. Delaney is happy to answer readers' questions via mail@clinuvel.com. Answers will be posted on the CLINUVEL website."


So, a third party will answer questions about Clinuvel, but still no indication that the company will do so itself. Seems like a half arsed attempt to set the discussion agenda to me. As an aside, anyone know if Delaney's father used to work for Clinuvel somewhere along the line?

Anyway, enough whingeing from me. Everything is OK because WE NOW HAVE A MOTTO IN LATIN!!!!!

PER DILIGENTIAM SINCERITATEMQUE PROGREDIMUR ET POPULUM SERVIMUS

I was worried that we didn't have one, but I can sleep easy now. If only they could combine that with the countdown clock in someway then things would be perfect!
  Forum: By Share Code

Frogster
Posted on: Feb 19 2018, 08:57 PM


Group: Member
Posts: 517

Hope ≠ expectation.
  Forum: By Share Code

Frogster
Posted on: Feb 19 2018, 11:41 AM


Group: Member
Posts: 517

New website due tomorrow. I wonder what joys it will bring? Hopefully a transparent, comprehensive window into the company, its operations, strategy and potential.
  Forum: By Share Code

Frogster
Posted on: Feb 13 2018, 10:51 AM


Group: Member
Posts: 517

That is the most useful newsletter that I can remember seeing from Clinuvel. Not exactly straight talking, but much more so than other recent efforts.
  Forum: By Share Code

Frogster
Posted on: Jan 31 2018, 09:17 AM


Group: Member
Posts: 517

Second consecutive quarter of receipts down compared to prior year...not by much, but down.

R&D costs a fair % lower than expected, but next quarter expected to be a fair bit higher. Timing of FDA NDA related stuff perhaps?

Admin and corp costs higher than expected, but productions and operating costs well below company expectations (once again....they often over estimate these costs).

Not sure what to make of this bit:

"Cash receipts are expected to fluctuate in the following quarterly reporting periods, reflecting the timing of customer payments following sales orders received for SCENESSE®"

Are they indicating that timing effects will benefit the next quarter, that they will negatively impact the next quarter, or are they simply telling us that sales are not the same as cash timing? Odd thing to say IMHO.


New director initial interest release out:

http://www.aspecthuntley.com.au/docserver/...&popup=true

2,900 ordinary shares held.
  Forum: By Share Code

Frogster
Posted on: Jan 31 2018, 06:50 AM


Group: Member
Posts: 517

It's been like that for at least a few weeks. I was on there perhaps 3 weeks ago, and I'm confident it was like that then.

As an aside, wow, doesn't time fly? Mr H has been General Manager of Clinivel UK for 10 years and 3 months already according to his profile. I never would have thought it was that long since he moved to the UK. blink.gif
  Forum: By Share Code

Frogster
Posted on: Jan 30 2018, 06:24 PM


Group: Member
Posts: 517

Learning on the job for young executives.....to an extent I can see some sense in that, as long as it's balanced by some who know the ropes.

Directors learning on the job?.....no thanks. They should be experienced, qualified and independent.

The board needs to challenge the executive. There needs to be a creative tension where the strategy and execution needs to be constantly challenged.

We will now have a board where 2 directors have served for over 9 years which means, under the board charter, they should not be considered independent, one who is experienced in privately held luxury and fmcg and now a Dr seemingly with no commercial board experience but a strong family connection to the group. I see her LinkedIn profile has been updated to say that she has joined Clinuvel to "Serve at the request of the Board as a Clinical Endocrinologist". We need one of them on the Board? If one was needed, surely a consultancy role would do? Wouldn't the board be better served with someone with product roll out experience in the US?
  Forum: By Share Code

Frogster
Posted on: Jan 30 2018, 07:59 AM


Group: Member
Posts: 517

She left Wyeth in 1994.
  Forum: By Share Code

Frogster
Posted on: Jan 25 2018, 12:53 PM


Group: Member
Posts: 517

Yes, I know.

It's the implication by the company that they are the same thing, along with the refusal to clarify that they are not the same thing when clarification is requested, that is misleading.
  Forum: By Share Code

Frogster
Posted on: Jan 25 2018, 11:45 AM


Group: Member
Posts: 517

If a lawyer wanted to get involved in these questions, I think they might have some fun.

The 2017 AR states on p54 that ordinary shares are quoted on all ASX member exchanges under CUV, and that shares (as opposed to securities, which might carry different rights to shares) are also quoted under UR9 and CLVLY. So, on that basis, the company implies that CUV, UR9 and CLVLY represent the same fractional ownership - that they represent the same thing - and presumably, therefore, that they have the same entitlements.

In the 2017 Corporate Governance statement, on p5-6 the company responds to Principle 6 - Respect the Rights of Security Holders of the ASXCGC CGPR. CUV claims to comply with recommendation 6.3, that "A listed entity should disclose the policies and processes it has in place to facilitate and encourage participation at meetings of security holders". CUV's response to this recommendation is:

"The Company encourages full participation of shareholders at the AGM to ensure a high level of accountability and discussion of the Company’s strategy and goals. The AGM exists, among other things, to promote shareholder communication by providing shareholders an opportunity to ask questions to Directors at the time of meeting. Directors are expected to make themselves available to meet with shareholders at the AGM. The external audit firm partner in charge of the Company audit is available to answer shareholder questions at the AGM. Shareholders who are unable to attend the AGM or other general meeting may submit questions and comments before the meeting to the Company or the external auditor (in the event of an AGM). Also, shareholders are permitted by the Company to vote online and by other methods prior to the AGM if they are unable to attend."

So, on the one hand UR9 and CLVLY are shares that rank alongside CUV, but on the other no facility is given to enable them to vote online if their holders cannot attend in person which means the statement they made above is inaccurate. At best, therefore, management's treatment of holders of UR9 and CLVLY is ambiguous, and at worst it's highly misleading.

Of course, questions around eligibility to vote with UR9/CLVLY or to attend the AGM could easily be answered by the company, but for some reason they choose not to.

For me this just smacks of another example where governance of CUV falls short. We already have the Chairman and another board member who have served for more than 9 years which, by the terms of the board charter, means they cannot be independent, which adds to the fact that several of the board participate in the performance rights scheme at least in part by virtue of the fact they provide executive functions. Again, according to the board charter, executives of the company cannot be independent.

Personally, I won't lose any sleep when Stan steps away from the Chair. He's failed to address these issues which have been in the background for some time. Hopefully the next Chairman will clean this mess up.
  Forum: By Share Code

Frogster
Posted on: Jan 24 2018, 12:25 PM


Group: Member
Posts: 517

Clinuvel Remuneration Committee take note:

http://ir.tesla.com/secfiling.cfm?filingID...HTM_TOC524719_5

This is how to align executive interests with those of shareholders and customers.
  Forum: By Share Code

Frogster
Posted on: Jan 20 2018, 06:35 PM


Group: Member
Posts: 517

Investek and PunkassDerm ARE ShareScene right now.

Top works fellas!
  Forum: By Share Code

Frogster
Posted on: Jan 11 2018, 06:36 PM


Group: Member
Posts: 517

I hope you're right, and I don't disagree with your sentiment.

I certainly agree with generous executive compensation if they manage to deliver strong returns for shareholders, but I also believe that very generous terms should only accompany very strong delivery. If his terms have suitable hurdles and benchmarks (in terms of achieving milestones, timeframes, quantum of commercial success, share performance, etc.) then fine - happy for him. If those hurdles are not hit, then the compensation should be foregone.

Last time around in the Performance Rights Plan (which he was by far the biggest beneficiary of), for me, the performance conditions were pretty soft.

In my view, make management rich in tandem with shareholders becoming rich, but not before.
  Forum: By Share Code

Frogster
Posted on: Jan 11 2018, 09:21 AM


Group: Member
Posts: 517

Stan exiting the Chair in 2019.
PW expected to stay till 2021 (persuaded at what price?).
  Forum: By Share Code

Frogster
Posted on: Jan 5 2018, 07:05 AM


Group: Member
Posts: 517

Confirmation that the Nye Metoder assessment process in Norway is still up and running (thanks FZ)

https://nyemetoder.no/metoder/afamelanotide-scenesse

The page has been updated to show that assessment is now underway, and was started 13/11/17. Presumably the data package has now been submotted.
  Forum: By Share Code

Frogster
Posted on: Jan 3 2018, 06:42 AM


Group: Member
Posts: 517

So the list sourced by Sharelooker and the Google translation of it whilst both accurate are, in fact, red herrings?

Is it closer to the truth to say the list refers only to OTC/retail type pharmacy products (and Scenesse would never be reimbursed for EPP under that channel), but the Scenesse review, under Nye Metoder, as a controlled, specialist, hospital only treatment is still live?

Thanks for clarifying the Norwegian process. CUV can sure get you jumping at shadows.
  Forum: By Share Code

Frogster
Posted on: Jan 2 2018, 11:09 AM


Group: Member
Posts: 517

Google translate of that page suggests that afamelanotide has been added to the Norwegian list of drugs that are not covered by central insurance. Is there a speaker of Norwegian on here that can confirm?

It appears the advice was published at the same time that NICE published it's refusal. I wonder if that is co-incidence, or if they are linked.

I suppose if it is linked to NICE then this too will be part of the ongoing NICE negotiations/litigation.

Not a helpful start to the year.
  Forum: By Share Code

Frogster
Posted on: Jan 1 2018, 06:51 AM


Group: Member
Posts: 517

Happy new year everyone.

Thanks for all the contributions made in good faith in 2017.

May there be many more in 2018, and may we see our business and company mature into something that provudes value to us all and all our various interests in it.
  Forum: By Share Code

Frogster
Posted on: Dec 18 2017, 06:42 PM


Group: Member
Posts: 517

For me, the post AGM slump is entirely down to PWs loose words around US HQ/domicile/listing/NDA progress which he made in the run up to it.

His comments allowed the expectation to grow that some or all of the above would be presented at the AGM. He gave the the impression that things were further developed than they are. When the actuality of the situation became clear, we've slipped back again on the idea that CUV has missed or misled us on timelines yet again.

PW has complained that European regulators question the validity and veracity of public statements made by listed companies, but then in the next breath says they can't be held to account for what they publish. Semantics are important. Precision in communication is important. He seems to think that quantity of media coverage is more important than quality of it, else why crow about 1,500 articles in 12 years.

PW seeded unrealistic expectations, allowed them to germinate, and then crushed them. His ability to communicate is at fault, and the board don't seem to be capable of revealing this truth to him.

Have they made any progress in the last 12 months? Perhaps, probably even, but not on the communications front.

I continue to love the product and it's potential, but recognise the limited skill set management display.

The silver lining is that the last 2 months have proven just how quickly the shares might rise when strong fundamentals - notably any FDA approval - are actually delivered.
  Forum: By Share Code

Frogster
Posted on: Dec 9 2017, 10:30 AM


Group: Member
Posts: 517

Another set of statistically significant data that proved efficacy more conclusively in a real world setting might also be useful in NICE/SMC/AWMSG/TGA type discussions and applications. Let's hope that's what this process ends up delivering.
  Forum: By Share Code

Frogster
Posted on: Dec 8 2017, 04:09 PM


Group: Member
Posts: 517

Just doing the usual trawl for crumbs, and came across the following page:

http://canadianassociationforporphyria.ca/page-18180

"Canadians with porphyria can access two treatments through the SAP - Normosang or Panhematin for Hepatic porphyria - Acute Intermittent Porphyria, Variegate Porphyria and Hereditary Coproporphyria; and Scenesse for Erythropoietic Protoporphyria."

The page was last updated on 10/1/17 so this might not be new news - that Scenesse is on a Canadian special access programme - but I don't recall seeing this previously.

If there are no accredited application centres in Canada - which to my knowledge there are not - then being on the SAP may not have yet led to any sales. We all know, after all, how tightly controlled distribution is. However, I wonder if any US approval, and subsequent accreditation of centres, might not only open up the US, but also Canada.
  Forum: By Share Code

Frogster
Posted on: Dec 8 2017, 07:22 AM


Group: Member
Posts: 517

I'm firmly of the opinion that they need to buck their ideas up about clarity of communication, but they have previoulsy made the point about the FDA wanting the EMA PASS safety data.

From the Press release "CLINUVEL PROVIDES UPDATE ON SCENESSE® FDA FILING" from 19/9/17 bullet point 1 says:

"EUROPEAN POST-MARKETING SAFETY DATA TO BE SUBMITTED AS PART OF NEW DRUG APPLICATION (NDA), EXPECTED IN DECEMBER 2017"

and the text goes on to say:

"CLINUVEL has agreed with the FDA that safety data generated under the European PASS will form part of the NDA submission. The first full statistical analyses of the European post authorisation data are due to be available in December 2017."
  Forum: By Share Code

Frogster
Posted on: Dec 5 2017, 09:42 AM


Group: Member
Posts: 517

Warum? Der genaue gebrauch von wörtern wird überbewertet, oder?
  Forum: By Share Code

Frogster
Posted on: Dec 5 2017, 07:36 AM


Group: Member
Posts: 517

Is that a new video? Can any of our German speaking friends translate the relevant bit for the linguistically challenged amongst us?
  Forum: By Share Code

Frogster
Posted on: Nov 29 2017, 09:48 AM


Group: Member
Posts: 517

johnnytech,

No, it's not clear to me what the answer to this is.

Their release from 19/9/17 says "EUROPEAN POST-MARKETING SAFETY DATA TO BE SUBMITTED AS PART OF NEW DRUG APPLICATION (NDA), EXPECTED IN DECEMBER 2017"

and

"The first full statistical analyses of the European post authorisation data are due to be available in December 2017."

I remember there was a debate on here about the ambiguity of the release, particularly the bullet point. Did it mean the data was expected to be submitted in Dec, did it mean the complete NDA was expected to be submitted in Dec, did it mean the data was expected to be received by Clinuvel in Dec?

p23 from yesterday says 2nd Annual Report EMA - Dec 2017 and Feb 2018 analyses.

I don't think Wolgen mentioned any of this in detail, so it's not clear to me what is actually expected in Dec, whether it will be delayed, whether the analysis due in Dec is not infact going to be complete or indeed who does what and why with whatever data is delivered whenever that might be. Sorry.

And with that, I think I'll take a break from talking about the AGM on here.
  Forum: By Share Code

Frogster
Posted on: Nov 28 2017, 09:22 PM


Group: Member
Posts: 517

Oh dear. Precision and accuracy is not their strong point.

Page 19 from the presentation today plots quarterly actual cashflows against "Scenario 3" presented at the 2015 AGM (p17 from that presentation). They called this scenario "PROGRESSIVE" in 2015, and "High" today.

The trouble is the chart from today doesn't infact show the same forward data as that of 2015.

Today it suggests the 2015 scenario projected $60m cash inflow in 2020 (easiest year to see since its the final data point from today), but the data presented in 2015 showed A$42m (give or take a million) i.e. near 50% difference for the same year.

I know they say this is NOT financial guidance, but if one were silly enough to ignore that and trust the demonstrated historical accuracy would be carried forward, one could be badly mistaken.

Euro/A$ exchange rate today is not very different to back in 2015, so that doesn't explain the difference.
  Forum: By Share Code

Frogster
Posted on: Nov 28 2017, 05:42 PM


Group: Member
Posts: 517

Oh, I nearly forgot.

I was keen to understand what it looked like to "erect a monolithic Australian architecture" but the opportunity to ask did not present itself. I did a little search however, and came across the attached.

I wonder what he was thinking at the time? Was is that Scenesse will be approved in 1073 days, that it will certainly be approved in 1073 days, or only that it might be approved in 1073 days?

Clinhope.....no, none that I caught.
Attached thumbnail(s)
Attached Image


 
  Forum: By Share Code

Frogster
Posted on: Nov 28 2017, 05:16 PM


Group: Member
Posts: 517

Sorry to be slow with a little write up after the AGM this year. It was so dull at the meeting I fell into a slumber and could not be roused from it.

Hmmm. What to say?

In summary - if anyone was expecting any kind of enlightenment – it was a bit of a fizzer. There seemed to be a lack of energy in the room, and possibly a few less attendees this year than last.

Stan got the formalities underway at a little after 10am, and started by telling us all to switch off phones and computers. This is interesting because they don’t provide hard copy handouts, so as the AGM progresses there is no ability to look at slides and really try to understand the interesting ones. The time with which you can digest each slide depends entirely upon the pace Wolgen scrolls through things on the big screen. Personally I felt he roared through the “Milestones” slides with barely a moment to digest them and their implications.

The instruction also means it’s impossible to pick up questions that you may have emailed through after the meeting started. If you did, sorry.

Willem Blijdorp turned up half way through Stan’s intro, but he got there in the end I guess.

Wolgen came on at about 10.30, promising to get through his stuff in 25 minutes. It took more like an hour.

There was the usual historical discussion about what they done in the last 10 years, and how hard the job had been. This year it was presented – at least in part – in a different format with a whole bunch of hexagons spread around a page. Maybe its interesting to see that they expect the General Public stakeholder group to climb in the hierarchy from near bottom historically to near top in the 2017-2020 period. Expect some press and advertising?

The financial discussion was pretty much a repeat of previous years with updated data. As far as the development of a significant US presence goes…..nada. They’re watching. They’re waiting. In the July newsletter, regarding basing in the US they said “In the coming weeks, we shall make our decisions public regarding the repositioning of the Group”. So now we know. 5 months is not enough weeks to make that decision.

FDA filing as you know is further delayed. This seems to be largely down to the EMA data needing to be included. The full statistical analysis they expected in Dec 2017 (19/9/17 release) will now only be due in February 2018. So, when they say , on 9/11/16,”CLINUVEL will submit the modular dossier on SCENESSE® on a rolling basis during the first half of 2017” to Wolgen that apparently doesn’t actually mean that they have stated a time line to the market that they will submit the dossier in the first half of 2017, and when Hay says (6/6/17, ScripRegAff)“(submission will be) Certainly by the end of this year” he apparently doesn’t actually mean that it will, with certainty, happen before the end of the year either and it’s not selective disclosure to make that certain statement to a closed audience.

So, really this underlines what we should already know. Trust nothing they say about timelines. They seem to feel no responsibility or formal association with them even when they make some pretty clear statements. Probably the same goes for the expectation stated last year that they would add 7 new countries to the EPP roll out this year. The moment it leaves Wolgan’s mouth it’s free to circulate, unencumbered by any sense of ownership or responsibility for those statements.

EU rollout and Media: they showed a clip of a Swiss TV debate where the insurers were given a hard time for only selectively reimbursing. The for case was argued by Rocco F. It was good to see just how strong the patient desire is to get the actual product.

Apparently a Judge in the AMNOG arbitration stated he was awarding Clinuvel 87% of their applied for price due to their transparency and integrity. .

Didn’t notice any mention of how many new EU markets are expected online in the coming year.

Growth 2020: dose regimen to be upped from 4 to 6. Marketing Application to be made in US, Japan, Australia. When? See above for timelines guidance.

They will look to makes acquisitions “eventually”.

So, overall, more hurry up and wait. Still some very powerful long term opportunities, not least because patients are crying out for the drug, but Clinuvel’s stepwise management approach will keep us waiting longer yet.

No really sure what else to say.

  Forum: By Share Code

Frogster
Posted on: Nov 24 2017, 07:52 AM


Group: Member
Posts: 517

Investek, xray, you have mail.
  Forum: By Share Code

Frogster
Posted on: Nov 21 2017, 08:09 AM


Group: Member
Posts: 517

Are you planning on attending? My comment about entry was assuming you had cuv. If your holding is a bit more exotic, you might want to check the drill re access and voting. Computershare will probably be more responsive than clinuvel. Maybe phone them for a quick answer?
  Forum: By Share Code

Frogster
Posted on: Nov 21 2017, 05:35 AM


Group: Member
Posts: 517

There will be a check in desk probably operated by Computershare. You might need i.d.. Tell them who you are, and they'll check you are a shareholder and are entitled to attend and vote. Its very easy.
  Forum: By Share Code

Frogster
Posted on: Nov 17 2017, 02:28 PM


Group: Member
Posts: 517

You'd think that'd be a simple question to answer, but it's not.

PW stated in the Annual Report that the company is awaiting a decision on Priority Review by the FDA. This implies Priority Review has already been applied for. I believe that is usually that is only done when the NDA has been submitted. On that basis some have speculated that we could see a decision on the NDA within the next few weeks. Other comments by PW suggest the NDA will in fact be made late this year/early next.

Once the NDA is submitted there will be a 2 month validation period, with the review itself taking up to 6 months (if priority review granted) or 10 if its not.

So, FDA decision on the NDA could be from now till Dec next year, depending on where you think we are in the process.

To me, interpreting the ambiguity of the various statements, August 2018 seems most likely. If earlier......great.
  Forum: By Share Code

Frogster
Posted on: Nov 14 2017, 01:29 PM


Group: Member
Posts: 517

Cheers Verhaven. Nice update.

Just imagine what might happen to interest levels if management ever start actually promoting the company themselves. The last non deal roadshow presentation was published via the ASX on 1/12/2014 - a crazy 3 years ago! I know some on here like the policy of secrecy, but personally I think they over do it by an order of magnitude.

Still, hopefully we're getting to the point where coverage and discussion of the company will develop a momentum all of it's own, and we'll see the story disseminated more widely even without the compliance of management. It'd be nice if they participated to shape the story, but if they don't want to I guess that's up to them.
  Forum: By Share Code

Frogster
Posted on: Nov 8 2017, 05:29 PM


Group: Member
Posts: 517

Plus, it already has been mentionned by ajshare.
  Forum: By Share Code

Frogster
Posted on: Nov 7 2017, 08:03 AM


Group: Member
Posts: 517

Looks even nicer now.
  Forum: By Share Code

Frogster
Posted on: Nov 6 2017, 10:17 AM


Group: Member
Posts: 517

We should be getting into speeding ticket territory now.

Will be interesting to see what they say in response if one is issued.

"We are not in possession of any sensitive information that is unknown by the market. Well, if you exclude the strategy update which we've been promising in dribs and drabs for a year now and also the exact timing of the US NDA, that is."

Good to see this rally has some reasonable volume driving it, unlike a year ago.
  Forum: By Share Code

Frogster
Posted on: Oct 30 2017, 09:43 AM


Group: Member
Posts: 517

Oh wow. I wasn't expecting great numbers given the difficulties we were somewhat are aware of, but these are bad.

First YoY quarterly comparison, and receipts are down 2% along with cash generation down 31%.
Also, a sequential quarterly progression of receipts down 6.7% and cash generation down 46.6%.
So, the rollout has stalled.

Meanwhile, Directors payments are at a 4 year high, and in the Newsletter released not even 2 weeks ago Wolgen "looks back at a successful financial quarter" and states again "the past quarter has been a successful one". Successful how? Successful against whose expectations and budgets? Several on here were looking for double digit millions in receipts. What would a failure of a quarter have looked like? CUV should have been making a profit warning given the market seems to have had a materially different expectation - not front running a successful financial quarter.

I guess this is what happens when you refuse to enter a dialogue with investors - you lose touch with their expectations and deny the reality of what's happening - to yourself and to them.
  Forum: By Share Code

Frogster
Posted on: Oct 27 2017, 03:53 PM


Group: Member
Posts: 517

Who knows what is behind the logo and site development page, but Artemis may be a better fit than at first thought:

http://www.goddessgift.com/goddess-myths/g...ess_artemis.htm

Artemis: Goddess of Light and Protector of the Vulnerable.

No smoke without fire?
  Forum: By Share Code

Frogster
Posted on: Oct 27 2017, 10:22 AM


Group: Member
Posts: 517

Looking at the holdings list again, National Nominees has disappeared (was 8m shares) and HSBC custody nominees has risen by 9.3m. My guess would be these 2 are linked but how or why I don't know.

Also, scratch what I said before about Fido, 108 and Ender not having changed.

That comment was based on the table on p52 of the new AR comparing it to data from p48 last year. However, BOTH reports state the numbers are based on data received up to 3 October 2016, so if that label is correct, all the data should be the same. However, the Lagoda numbers are different this AR vs last.

It looks like there's an error in the table title. Disclosures received up to 9/8/17 (the date of the last Lagoda substantial holder disclosure) for this year's AR perhaps? Sloppy practice CUV.
  Forum: By Share Code

Frogster
Posted on: Oct 27 2017, 09:33 AM


Group: Member
Posts: 517

And front cover imagery of Flinders St station. What does that add to our geographical analysis of previous AR covers?

in addition, a few initial comments:

- Vitiligo is on hold till after EPP approval in US. Expectation that talks re vitiligo steps will recommence in 2018.
- Several mentions that they play cards close to their chest, and will continue to do do - so don't expect any decent IR any time soon. "keeping all interested parties at bay when communicating" Yes, I think we get that.
- Bit of a diss to Florian Homm "meltdown and sell off by hedge fund in 2007".
-"We expect VALLAURIX to make its first topical product lines public in 2018/19, whereby we now await registration of the first products" Does that mean launch and sales in 2018/19 or simply details of what they are will be known then?
- Plans to expands the group will be announced at the AGM
- Top 20 holders now have 81.39% of the company vs 79.79%. The entry point to the top 20 is 153000 shares vs 183000 last year. HSBC nominees now hold 15.6m shares vs 6.3m last year. This is BY FAR the biggest change in holder, but being a nominee, it's impossible to say what or who is behind this - could be coincidental that everyone is using HSBC nominees, but then again maybe not.
- Fidelity, 107 768 896 and Ender holdings unchanged. Lagoda up to 5.255m.
  Forum: By Share Code

Frogster
Posted on: Oct 26 2017, 06:21 PM


Group: Member
Posts: 517

I wonder which analysts have provided those cash flow forecasts. Do they know the company, or are they simply bot/quant forecasts?
  Forum: By Share Code

Frogster
Posted on: Oct 25 2017, 07:09 AM


Group: Member
Posts: 517

I'd be happy with anything above 7.5m receipts and 28m cash at quarter end.
  Forum: By Share Code

Frogster
Posted on: Oct 23 2017, 07:10 PM


Group: Member
Posts: 517

Nice contribution. Thanks.
  Forum: By Share Code

Frogster
Posted on: Oct 20 2017, 07:01 AM


Group: Member
Posts: 517

Nice idea Royco, but I'm with KRD -highly unlikely IMHO.
  Forum: By Share Code

Frogster
Posted on: Oct 17 2017, 12:08 PM


Group: Member
Posts: 517

Hey Clinhope, did PW employ you to set up the legendary original countdown clock? Shame I'm busy on that Saturday.

biggrin.gif
  Forum: By Share Code

Frogster
Posted on: Oct 17 2017, 09:24 AM


Group: Member
Posts: 517

I'd add the following:

-INCHING towards the complete new drug application (NDA)
-Clinuvel looks back at a successful FINANCIAL quarter
-Clinuvel will ATTEMPT to revise the PASS protocol
-The past quarter has been a SUCCESSFUL one (said twice in the release)

My summary: slow and steady, but making progress. The key question is what rate of progress is acceptable?
  Forum: By Share Code

Frogster
Posted on: Oct 5 2017, 07:19 PM


Group: Member
Posts: 517

I intend to go and I intend to ask several questions.

Given they lack any effective IR contact point and that this is the sole opportunity in the entire year to ask questions directly of management, I'd be surprised if they could justify shutting down the Q&A part until everyone has exhausted themselves.

We should also note that not only does the Corporations Act give us they right to ask questions, but it also gives us the right to make comments on how the company is being run.
  Forum: By Share Code

Frogster
Posted on: Sep 26 2017, 12:02 PM


Group: Member
Posts: 517

Thanks for posting that Clinhope. IMHO it's a decent summary.

I tend to not tell friends/family about investment opportunities as a general principle. As Doogieson said, big potential downside, little potential upside. Having said that, I did tell a neighbour about CUV a while back. He bought and is, I believe, in the black and retains a positive long term view on the company.

I'm of the opinion that the actions of the company - or lack thereof - is what has stifled interest to this point in time. If, as a potential investor, you hear a very positive story on a stock from a friend/relative/neighbour my bet is that most investors will seek corroboration of the story from elsewhere - whether that be company presentations, broker coverage or elsewhere. Sure, you might not 100% believe these sources, but most investors would surely do a little due diligence beyond a "chat over the garden fence".

Our trouble? There is no other source. We have no broker coverage - easily rectified if the Walnut so desired - but they don't even promote themselves. Reading through quarterlies, ARs, ASX releases, AGM papers is one thing, but many investors like to get this stuff boiled down into a summary, an investor presentation if you like. You know when the last time that CUV did one of these? December 2014 is the last one I can find. As ever, I'm not talking about a Powerpoint full of meaningless promises and blue sky lies, but I am talking about a company having a coherent, digestible summary of it's status and direction that is easily accessible to newly interested parties.

Most of this board has, I think, been around since they used to do this stuff or has, somehow or other, waded through the statutory releases and somehow come through the other side. Maybe Clinuvel 2020 will be the starting point of a proper communications effort. Then again, maybe not.
  Forum: By Share Code

Frogster
Posted on: Sep 25 2017, 08:43 PM


Group: Member
Posts: 517

Hey, don't forget that they might tell us that they might someday tell us about Clinuvel 2020!
  Forum: By Share Code

Frogster
Posted on: Sep 19 2017, 01:43 PM


Group: Member
Posts: 517

It's nothing to do with being gullible, it's just an ambiguous bullet point on their part! Your interpretation is perfectly valid, but equally so the other one (IMHO). Forget my addition of the implied word "available". Is the data expected in Dec or is the submission expected in Dec? It's not clear from the bullet point, but to keep this in context, I'm just playing the Devil's advocate.

Irrespective of which is correct, I agree with your suggestion that submission SHOULD follow pretty quickly after the data is generated. After the statistical analysis is complete, what more is there for them to do to the numbers other than forward a big spreadsheet? So, do that in Dec/Jan? Validation in Feb/March? Approval decision in Aug/Sep? Sales.......hopefully alot quicker than in Europe if PASS structure agreed prior to approval and further national body negotiations not required (unlike in Europe).
  Forum: By Share Code

Frogster
Posted on: Sep 19 2017, 01:05 PM


Group: Member
Posts: 517

Did he say the NDA would be submitted in 62-92 days, or did he say the post marketing safety data will be available in 62-92 days and this will be included in the NDA which will be submitted at some unspecified point thereafter?

It takes a special talent to write ambiguous bullet points, and CUV has it in spades.
  Forum: By Share Code

Frogster
Posted on: Sep 19 2017, 10:22 AM


Group: Member
Posts: 517

Yawn.

I wonder if there is any relevance to the fact that the CAPIG ASAR documentation said the EU PASS had already generated safety data, but would take till the end of the year to generate efficacy data, and today CUV is saying it will wait till Dec for safety data.

Possibly nothing......but a subtle difference nevertheless.
  Forum: By Share Code

Frogster
Posted on: Sep 14 2017, 09:03 PM


Group: Member
Posts: 517

In simplistic terms, the role of the FDA and the EMA are very similar. They approve drugs for sale in a regional jurisdiction on the basis of firstly safety and secondly efficacy. Though they may be similar, they each define their own endpoints for what constitutes acceptable proof of either. They respect each other as professional organisations, and pay attention to usage/efficacy/safety data that may emerge at any time from either - or indeed any - jurisdiction. I think it's fair to say that many marketing approval outcomes will be similar between the 2 regions because they are treating genetically similar populations. In other words - as we well know - the FDA and EMA duplicate each others work to a certain extent, and what one does may at least give a clue as to what the other will do. Having said that, they are not tied to each other in any formal way.

What they do not do is pay the end bill for drugs. This is left to other parties.

In an ideal world, any drug that is safe and effective should be available to any patient who wants and needs it. However, this is sadly not the case. What the likes of NICE, AWMSG, and SMC basically do is different to the FDA and EMA. They work out if drugs that have EMA approval (irrespective of the FDA stance on the same drug) are also cost effective in terms of patient outcomes within the budgetary constraints of the payor (in each case here, different branches of the NHS). They are essentially making the moral decision of should they spend part of their limited money on EPP patients instead of, for example, heart disease patients. So they basically say the EMA tells us this is safe and useful, but for the effect it gives, can we afford it?

The stance of the FDA is of very limited importance to AWMSG (for example). They care about - and are controlled by - what the EMA thinks. Have a look at the AWMSG secretariat assessment report for Scenesse. There is one mention of the FDA, and that is only to reference a comment made at a scientific work shop. There are, however, lots of EMA references.

Whilst FDA approval - were it in place - from the point of view of patient equity might have a minor impact on the moral desire of AWMSG to recommend the drug for access via NHS Wales, it would have zero impact of the ability of NHS Wales to fund it. The Preliminary Appraisal Recommendation rejected Scenesse on the basis of cost effectiveness not being proven, and again the stance of the FDA has no bearing on that.

Over time, as more evidence is gathered of the life changing effects of the drug, then hopefully regulatory authorities will bow to the weight of patient experiences and become more accepting of the "soft" data that proves it's worth. Any US patient experiences will of course help here, so in a sense a US approval might help, but for me, it's a slow, creeping, cumulative effect, and will never be a slam dunk.
  Forum: By Share Code

Frogster
Posted on: Sep 14 2017, 02:03 PM


Group: Member
Posts: 517

Much as I'd like to be able to agree with you, I don't think it'll be that simple. Incrementally, sure, FDA approval would help the backstory, but NICE, AWMSG, SMC etc. are all their own beasts, and don't care much what the FDA says.

If FDA approval does help the most powerful way would be if the economics of greater product volumes allow for a lower level of pricing whilst maintaining profitability. I guess a lot of the scope for this depends upon any FDA PASS requirements and their associated costs.
  Forum: By Share Code

Frogster
Posted on: Sep 7 2017, 03:46 PM


Group: Member
Posts: 517

Same for a Scenesse search, or even Clinuvel.
  Forum: By Share Code

Frogster
Posted on: Sep 6 2017, 02:59 PM


Group: Member
Posts: 517

Ooops. Thanks ajshare. My mistake.

I read the date the rebalance actually occurs as being the date the changes are announced.

At least my sense was correct that CUV wouldn't be involved this time round. blush.gif
  Forum: By Share Code

Frogster
Posted on: Sep 6 2017, 01:22 PM


Group: Member
Posts: 517

The twice yearly ASX300 index rebalance announcement is due soon - after market close on the 3rd Friday of the month in fact. So that should be a week on Friday, 15/9.

Will we make it this time round? There are about 25 stocks with a lower market cap than CUV in the index, but it also takes into account liquidity. My sense is that we'll not make it due to illiquidity, but I'd love to be proved wrong.


Quote/

Selection Criteria A security must be listed on the ASX and be an ordinary or preferred equity stock (e.g. no bonds or warrants etc.). Its average daily market capitalisation for the previous six months must be considered institutionally investable and meet a minimum benchmark size. Liquidity must be adequate and its public float (shares not owned by company founders, directors, government agencies etc.) must also meet a minimum requirement.

Note: The above criteria are for inclusion into the index and not for continued membership. As low index turnover is important, a security in the index may on occasions violate one or more of the selection criteria without being removed.

/End Quote
  Forum: By Share Code

Frogster
Posted on: Sep 6 2017, 08:36 AM


Group: Member
Posts: 517

Another document - the CAPIG summary - from the clinician and patient group meeting has appeared on the AWMSG Scenesse assessment page.

http://www.awmsg.org/awmsgonline/app/appraisalinfo/634

Hopefully this, and the raw content behind it, is enough to get the product over the line next week.
  Forum: By Share Code

Frogster
Posted on: Sep 1 2017, 08:02 AM


Group: Member
Posts: 517

Reading through the AWMSG assessment a couple of themes struck me. These themes were in some ways very familiar, but in one area in particular added a lot of detail.

Firstly, and crucially, Scenesse is considered safe. Not news, but reassuring to hear again.

Secondly, it's a proper first effective treatment for EPP. Again, to most of us, not news, but reassuring.

Thirdly, traditional statistical analysis of trial data doesn't work well with the characteristics of EPP. Again, not news, but there's alot of detail about where the statistics fall short, especially in the cost effectiveness area.

Finally, budgetary impacts in Wales are hard to quantify since there's a series of question marks over how many patients there could be and how many implants they'd need.

It feels to me that this pattern is fairly well trod. Similarities to the original EMA arguments, and the commercial developments in Germany, Italy, Netherlands and Italy. The key factor that has got Scenesse over the line in each of those markets has been, from what I can see, is the patients voice. Hopefully the CAPIG meeting was similarly compelling and by all account "went quite well" (kudos to Reality Check for finding that one).

Irrespective of what happens in Wales (or Scotland) I guess there is now an opportunity for Clinuvel to act on the AWMSG feedback and sharpen the submission to NICE. Whilst meaning no disrespect to Welsh or Scottish patients, it's the English submission that management really need to nail from a commercial point of view.

With this in mind, there's a very interesting point made in the AWMSG assessment, that being that the onerous PASS protocol - the thing that took so long to agree and delayed launch considerably - has already generated safety data, and, importantly is expected to generate longer term effectiveness data by the end of 2017. Assuming this is positive, I hope that data can be used with NICE. My guess is also that waiting for the PASS data to become statistically significant is why FDA application has slipped as the rate at which the PASS database was populated by patients was slower than initially expected due to the roll out problems we're all aware off. It's just a guess, but seems the most plausible explanation to me.

Whilst I'm at it, I may as well chuck in my 1p on the 4E results (only 1p, not 2p, not much to add over what's been said......good start.....solid, not stellar.....invest in the boring....) but I found it interesting that at end 2017 they had 12 end users for the commercial sales versus just one at end 2016. I guess that means 12 hospitals/clinics online. I guess these should all be online for the full 12 months in the current year, and hopefully we get a bunch more too. Finally, Cyprus, you asked how Vallaurix went from 90% to 82%. It's always been 82% (as reported in the 2015 and 2016 ARs).
  Forum: By Share Code

Frogster
Posted on: Aug 31 2017, 09:58 PM


Group: Member
Posts: 517

Apparently the CAPIG meeting in question "went quite well".

/Quote

Reality Check's post @ Jul 22 2017, 05:50 AM
For those that don't follow Clinuvel closely...

Regarding AWMSG, I believe their appraisal group met with both EPP patients and doctor specialists today to help rationalize approval for Scenesse reimbursement. High level, the meeting went quite well. We should hear a final decision at the Sept 13, 2017 meeting date.

Guidance Title: afamelanotide (Scenesse®)
Guidance Type: All Wales Medicines Strategy Group appraisal
Expected Date: Jul 2017

https://bestpracticecommunity.mgp.co.uk/oth.../detail/id/6401

http://www.awmsg.org/awmsgonline/app/appraisalinfo/634

/End quote
  Forum: By Share Code

Frogster
Posted on: Aug 24 2017, 12:17 PM


Group: Member
Posts: 517

Super find. Thanks very much for sharing.

After the recent SMC advice date that wasn't, I'm personally not going to assume that means a filing has in fact already been made, but it certainly suggests we're very slowly moving in that direction.

One of those documents you linked to was from May. I think it was June that Hay announced to the key stakeholder group - the paid subscribers to Scrip Regulatory Affairs - that the target of an H1 filing would be missed.

My guess is that your document was based on anticipated timelines prior to missing that target. Nevertheless, it's encouraging to see that US authorities other than the FDA are aware of the existence of Scenesse, and perhaps the US roll out will avoid what appears to have happened in Europe i.e. every negotiation process begins afresh with national authorities after EMA approval.
  Forum: By Share Code

Frogster
Posted on: Aug 16 2017, 06:24 PM


Group: Member
Posts: 517

Preliminary final report (4E) will be before the end of this month (last year was 25/8).
Annual report glossy will be published towards the end of October (last year was 26/10).
In addition Q3 Cash receipts quarterly (4C) will be published by the end of October (last year was 31/10).
  Forum: By Share Code

Frogster
Posted on: Aug 14 2017, 03:02 PM


Group: Member
Posts: 517

Perhaps we misunderstood.

Perhaps 2020 is not the strategy implementation date, but rather the strategy publication date.
  Forum: By Share Code

Frogster
Posted on: Aug 8 2017, 04:04 PM


Group: Member
Posts: 517

I wonder if they might be having problems credentialing an expert centre, or setting up the contracts for the PASS protocol in the way that some German centres have proven tricky.
  Forum: By Share Code

Frogster
Posted on: Aug 7 2017, 07:45 PM


Group: Member
Posts: 517

Well, that is peculiar.

The search which a few days ago stated the SMC advice on afamelanotide would be issued today (I'm sure you all clicked the link and saw the date too) now has no reference to a publication date at all. This change has happened within the last hour.

http://www.scottishmedicines.org.uk/Genera...p;search=Search

Elsewhere on the SMC site the product is listed as being a "Medicine with advice withheld pending product availability", with a TBC alongside the advice due date. This TBC label is now consistent across the couple of pages on the site where afamelanotide is listed. I've no idea how to correctly interpret "pending product availability".

http://www.scottishmedicines.org.uk/SMC_Ad...Category?term=9

So, it seems today may not be the day for an announcement after all.

/Sigh/

As you were.
  Forum: By Share Code

Frogster
Posted on: Aug 6 2017, 02:24 PM


Group: Member
Posts: 517

Indeed Clinhope. Scotland would be a relatively small market, but a positive opinion, if that's the way it goes, would be good to get.

I hope the data proves correct, and that we do in fact see an opinion published on time. We have seen elsewhere that further time has been added to pay closer attention to the patient voice, and I guess that's still a possibility here. Come 11pm Australian time, I guess we'll know.
  Forum: By Share Code

Frogster
Posted on: Aug 5 2017, 03:26 PM


Group: Member
Posts: 517

Looks like we might hear what the Scottish Medicines Consortium thinks of Scenesse on Monday:

http://www.scottishmedicines.org.uk/Genera...p;search=Search

There's also a timetable elsewhere on the SMC site which suggests the advice will be posted to their website after 2pm UK time. It also suggests that CUV was told of the advice on 7/7.

Good luck to all longs.
  Forum: By Share Code

Frogster
Posted on: Aug 4 2017, 08:37 AM


Group: Member
Posts: 517

On my PC now rather than my phone, so can grab the Royal College of Physicians text easily now. My comment was paraphrasing their submission in the scoping docs which were:

"The estimate of 325 EPP patients in England derived from a 2006 study is a significant underestimate. More recent literature (Elder et al, JIMD 36: 849-85, 2013) calculated the prevalence of EPP in the UK as 25.4 cases per million, which would suggest over 1000 cases in England. It should be noted that the clinical phenotype varies and some patients are more severely affected than others."


Not sure if it's ever been detailed on here but if not the referred academic paper, published in the Journal of Inherited Metabolic Diseases, is this one:


Inherit Metab Dis. 2013 Sep;36(5):849-57. doi: 10.1007/s10545-012-9544-4. Epub 2012 Nov 1.

The incidence of inherited porphyrias in Europe.
Elder G, Harper P, Badminton M, Sandberg S, Deybach JC.
Abstract
Retrospective estimates of the prevalence of porphyrias have been reported but there has been no large scale prospective study of their incidence. The European Porphyria Network collected information prospectively over a 3 year period about the number of newly diagnosed symptomatic patients with an inherited porphyria (335 patients from 11 countries). Prevalence was calculated from the incidence and mean disease duration. The incidence of hepato-cellular carcinoma (HCC) in acute hepatic porphyria and the prevalence of patients with recurrent acute attacks of porphyria were also investigated. The incidence of symptomatic acute intermittent porphyria (AIP) was similar in all countries (0.13 per million per year; 95 % CI: 0.10 - 0.14) except Sweden (0.51; 95 % CI: 0.28-0.86). The incidence ratio for symptomatic AIP: variegate porphyria: hereditary coproporphyria was 1.00:0.62: 0.15. The prevalence of AIP (5.4 per million; 95 % CI: 4.5-6.3) was about half that previously reported. The prevalence of erythropoietic protoporphyria (EPP) was less uniform between countries and, in some countries, exceeded previous estimates. Fourteen new cases of HCC (11 from Sweden) were reported in patients with acute porphyria. Sixty seven patients (3 VP; 64 AIP: 53 females, 11 males) with recurrent attacks of acute porphyria were identified. The estimated percentage of patients with AIP that will develop recurrent acute attacks was 3-5 %. In conclusion, the prevalence of symptomatic acute porphyria may be decreasing, possibly due to improved management, whereas the prevalence of EPP may be increasing due to improved diagnosis and its greater recognition as a cause of photosensitivity.


I'm sorry to say that I can't link to the full text of the article, but depending on who you are and how much you want it, you might be able to get it through the full text option here.

https://www.researchgate.net/publication/23...yrias_in_Europe

There is an interesting table (table 4) which suggests, based on rates of prevalence, that total cases in the UK (not just England) could be as high as 1552, Interestingly France is estimated at only 286 which goes some way to explain why France is not yet a focus.

I post this just for comparison to the paper Seeva222 has highlighted. I'm not for a second suggesting "my" link is right and the other wrong, but I thought more detail on the range of estimates might be useful.
  Forum: By Share Code

Frogster
Posted on: Aug 3 2017, 09:26 PM


Group: Member
Posts: 517

In the scoping documents of the NICE application the Royal College of Physicians say that recent literature may suggest over 1000 cases in England alone (Scotland, Wales, Northern Ireland would be extra). They stated that 325 derived from 2006 study was a significant underestimate.

The consensus view of the stakeholders in the NICE application is 500 to 600, but the Royal College of Physicians is a highly credible body, so we should probably pay their high end estimate at least some attention.
  Forum: By Share Code

Frogster
Posted on: Jul 31 2017, 01:04 PM


Group: Member
Posts: 517

Yes....that's what I said!
  Forum: By Share Code

Frogster
Posted on: Jul 31 2017, 10:13 AM


Group: Member
Posts: 517

Happy to see those numbers. They're great versus my expectations. After the disappointment of the previous quarter I was only looking at A$4m receipts. Happy to be wrong this time.

Couple of comments from other lines items:

-Cash generation was strong on these receipts, helped by corporate costs nearly A$0.4m below guidance - my guess is this might be an exchange rate effect (more on this in a minute) - and also by production costs being also nearly A$0.4m below guidance. Even if these items weren't flattering, I'd be pleased to see the cash generation. It's still better than I thought it'd be.

-After a few quarters of very low R&D spend, the current quarter will be ramped up a little again to A$0.15m. Scenesse Enfance/Goat thing spending ramping up? They also spent nearly 4 times more in the reported quarter than predicted (prediction was only A$0.02m).

-Production costs for the current quarter are expected to be A$0.7m. I find it a little tricky to interpret this. They were expecting A$1m for the quarter just reported, and it was only A$0.6m. Does this mean they are already stocked up for peak seasonal demand? Does it mean peak demand is going to weaker than previously thought? Does it mean they're just getting better at forecasting this cost (they've been way off a number of times now). Time will tell, but my guess is a combination of these 3 factors.

-I wouldn't be surprised if we see a corrected version of this 4C published. Item 4 in it seems to have arithmetic/presentation errors. Item 4.2 suggests A$4.626m was USED in operating activities rather than was GENERATED by it, and Item 4.5 suggests exchange rate movements consumed A$0.375 rather than inflating balances as suggested by the difference listed at year end (28) versus that at the 9m stage (403). If they have listed the sense of these movements correctly, then the cash at the end of period should be 18772-4626-21-375=13750. Given they have a bank balance of A$14.339m this cannot be right and must simply be an error!
  Forum: By Share Code

Frogster
Posted on: Jul 29 2017, 03:30 PM


Group: Member
Posts: 517

1.5?
  Forum: By Share Code

Frogster
Posted on: Jul 29 2017, 02:06 PM


Group: Member
Posts: 517

Clinhope,

I don't know the ins and outs of the FDA process in detail, but I do know that PW said the following in the February Newsletter:

"The quality of the NDA dossier dominates our approach in order to gain time during the review process, which contrary to what the label of “rolling submission” may suggest, the FDA will only commence its review at the end of the “rolling submission” process."

He also said rolling submission would be completed in H1 2017, so who knows how precise and accurate that statement is?

Trading in the last few days has been odd. Having been heavily bid up on very few shares at the close on Thursday, it gets slammed on Friday before any numbers are released? It strikes me as being an intentional trading pattern, exploiting the general lack of liquidity and nervousness around the figures, or a panic retail offload for reasons unknown. Perhaps someone expected the results to be announced on Friday, and for whatever reason had to go through with the set up on Thursday night? Anyway, who knows?

No doubt the roll out is facing more challenges that I'd hoped for by this stage, and I certainly have a low level of comfort with my expectations for the quarter (due to seasonality along with every other factor!), but I do know that I didn't buy CUV for it's cash receipts from Apr-Jun 2017.
  Forum: By Share Code

Frogster
Posted on: Jul 27 2017, 04:45 PM


Group: Member
Posts: 517

It's only going to be cash flow figures before the end of this month.

We'll have to wait till the end of August to see P&L and EPS figures.
  Forum: By Share Code

Frogster
Posted on: Jul 25 2017, 02:19 PM


Group: Member
Posts: 517

With the "International Designation" a NASDAQ listing is the option that springs immediately to mind, so I thought I'd check to see if we meet the listing criteria for NASDAQ.

https://listingcenter.nasdaq.com/assets/initialguide.pdf

Page 6 in here (from Jan 2017) suggests we'd fail to meet the criteria for the top tier NASDAQ Global Select Market, but p8 and p9 suggest we meet the Market Value Standard criteria for the second tier NASDAQ Global Market or the third tier NASDAQ Capital Market. Depending on the FY results in a few weeks, we might also meet the Income Standard for both these tiers very very soon. So, NASDAQ might work.

As we've discussed on here before (what seems like years ago.....), the following scenario once again looks plausible.

If management were able to go to the US as:

a) a cash generative, debt free, profitable company, with
b) a product already approved in the EU, and
c) a US NDA/approval for EPP in place/pending, looking for a
d) US listing alongside a capital raise, to fund
e) phase 3 US vitiligo trials, supported by
f) strong CUV103 trial results

then it could be a compelling story. As an aside, in just checking my notes from the last AGM, PW was asked about the possibility of a US listing. His answer suggested this was likely only if true corporate value was not reflected in the share price.

I guess each of our respective share holdings reflect our views on that one.
  Forum: By Share Code

Frogster
Posted on: Jul 25 2017, 01:11 PM


Group: Member
Posts: 517

Clinuvel 2020: a scenesse odyssey
  Forum: By Share Code

Frogster
Posted on: Jul 25 2017, 11:25 AM


Group: Member
Posts: 517

Not sure that a complete Australian windup is on the cards......otherwise how could there be a monolithic Australian architecture!??

At the very least, I think they'd keep a listing here. Beyond that, perhaps not much will remain. Something else to talk about at the next AGM i guess.
  Forum: By Share Code

Frogster
Posted on: Jul 25 2017, 10:20 AM


Group: Member
Posts: 517

To add to KRD's comments:

Talk of erecting "a monolithic Australian architecture in which all stakeholders can take pride in years to come". Errrm. Wow?

Clinuvel 2020:
Hints at more R&D spending, perhaps at or above 12% of revenues, perhaps to be spent through Vallaurix.
Human talent identified in the Asia Pacific region, and coming publications will raise profile in US, ASEAN and EU.

Euro Distribution:
98% of first year patients are seeking a second year.
2 regulatory inspections already this year in the UK.
No comment at all on rate of progress in new markets/insurance discussions/price negotiations.
Name check (again) for Lachlan Hay on how these (inspections) were dealt with. (LH may not do the things some of us expect of him, but PW sure seems to like him).
Regulators don't seem to trust the company on promises of no off label use. PW points to the significance of listed company public statements in this regard. (I wonder if regulators, or anyone else, could find any public statement made by Clinuvel that haven't been delivered on?(*))

US Filing:
Rolling dossier submission ongoing.
No statement as to why H1 timeline (*) was not met.
Hint that Euro rollout data may be a factor.
No guidance on when submission will be made, but once the FDA has validated the dossier, CUV will announce the start of the review clock.
Company is considering developing significant US operation presence and/or listing there. Many comments of higher relative liquidity of the ADR vs ordinary stock. Decisions to be made public in "coming weeks"
  Forum: By Share Code

Frogster
Posted on: Jul 20 2017, 11:17 AM


Group: Member
Posts: 517

Like FarmaZutical, I’m fed up with the disdain, bordering on contempt, with which management treat us. I, too, have tried privately to encourage a more open, complete and effective dialogue. All I’ve got in return is stonewalling.

I guess there are a couple of routes open to anyone who wants to express a concern – formal and informal ones.

The ultimate prize of a formal route would, I guess, be to get someone on the board as Mauricinho suggested. I don’t see this as realistic given Fido and Lagoda don’t even have board representation.

Getting a formal resolution on the AGM agenda which invited shareholders to express their satisfaction/dissatisfaction would be a more realistic target, but even doing that would not be a simple thing. Under Australian Law the Corporation Act gives members the right to put a resolution to the AGM if the resolution is proposed a) by members who can cast at least 5% of the votes on the resolution or b) by at least 100 members who can vote at the meeting. Notice of the resolution has to reach the company at least 2 months before the AGM. Given that quite a few of those who appear unhappy seem to be US based, it’s maybe fair to assume they couldn’t cast votes anyway. So, whilst it’s possible, getting something to vote on at the AGM would in fact be quite hard – that 100 member bar might be hard to reach.

I think old school, hard copy individual letters sent to Stan McLiesh would be most effective. He has in the past stated that he sees his role as Chair is to “represent investors” and I recall that once, I think on the subject of the last Performance Rights plan, he referred to not having received any complaints about it. So, with this in mind, if we have complaints, maybe we should send them directly to him. If a number of us do this, I think that might have more impact than a group letter.

I’m also all for the idea of making the questioning at this year’s AGM a little harder than it’s previously been. Last year was better than before, but I’m sure there’s more to come. In addition to the right to ask questions, we should remember that the Corporation Act also gives us the right to “make comments on the management of the company”. We have the right to be direct about our concerns – not just to imply them via the topic of questions.

Finally, there is another route for expressing a general level of dissatisfaction that some might not be aware of. Each year we have to vote on the Remuneration Report. If more than 25% of votes cast reject the report, then this is considered a “first strike”. If at the next AGM the Remuneration Report is similarly rejected by 25% of votes cast then this is considered a “second strike”, and this triggers an immediate vote where shareholders are asked if the entire Board should be forced to stand for re-election. This motion needs to get more than 50% of votes to trigger complete Board re-election, which would take place at a meeting less than 90 days later.

It’s a pretty powerful way to register dissatisfaction with how things are being run.

  Forum: By Share Code

Frogster
Posted on: Jul 19 2017, 04:39 PM


Group: Member
Posts: 517

In the absence of any other news to talk about, I thought I might try to introduce a topic that has been lurking at the back of my mind lately – the Performance Rights Plan.

At the 2014 AGM shareholders voted on, and approved, a Performance Rights Plan which, if delivered in full, will see Wolgen awarded 2.499.810 shares, McLeish 120,000, Shanahan 100,000 and Ishag 70,000.

The plan had 4 Performance Condition triggers which would see tranches awarded against the following milestones:

PC1: Shareholders approve the right plan at the AGM

PC2: EC ratification of positive EMA opinion of Scenesse for EPP

PC3: First commercial sale of Scenesse in Europe

PC4: Submission of a dossier to the FDA applying for marketing approval in the US.

Obviously PC1 through 3 have already been triggered. PC4 has not been, but as and when the US dossier is submitted Wolgen will pick up another 624,975 shares, currently worth a little over $4m. This could (should) well happen before the 2017 AGM. That makes me wonder if we'll be asked to vote on a new Performance Rights Plan this time round.

If we are, what kind of conditions do you think would be fair to be included in the hurdles? I'm all for having a motivated and incentivised management team, but the current plan always struck me as being pretty dam generous on the hurdles – no metric taking into account the level of commercial success of the roll out, whether or not US approval is actually even achieved and no timeframes within which to actually deliver anything.

So, what hurdles would you consider fair next time round? My first shot might look like this:

PC1: A$50m revenues from US EPP sales by FY18/19 with 33% decrease in award for each year the target is not met.

PC2: US vitiligo approval within FY19/20 with 33% decrease in award for each year the target is not met

PC3: Major regional marketing approval (US or Europe) for Chivere by FY21/22

Where do you think the correct balance of carrot and stick lies when rewarding management for delivering a good job for shareholders and not just encouraging them to show up and go through the motions?
  Forum: By Share Code

Frogster
Posted on: Jul 17 2017, 02:10 PM


Group: Member
Posts: 517

Ahhhhh.....OK. You know all about it then.....not trying to teach you to suck eggs.

On a different topic, and at the risk of being accused of perpetuating some of the recent diversionary discussions, until something more meaningful crops up some of us may find benefit in some of the articles and papers hyper-linked in the following course summary:

http://callingbullshit.org/syllabus.html

I hope you find this as amusing as I did. Maybe it should be required reading before being admitted to this forum.
  Forum: By Share Code

Frogster
Posted on: Jul 17 2017, 01:18 PM


Group: Member
Posts: 517

balimike, I don't know how long you have followed CUV, but I see you've been on this board since early this year.

CUV has disappointed in it's communication, and indeed failed to deliver on it's promises many, many times over the years. They are simply shocking at it. I get that there are things they genuinely can't tell us, but the approach they take to talking to us about our company is just ridiculous. This has to change in my opinion.
  Forum: By Share Code

Frogster
Posted on: Jul 12 2017, 04:08 PM


Group: Member
Posts: 517

https://greenbeautyteam.com/answers-advice/...ith-goats-milk/

https://hautegoat.com/pages/benefits-of-goa...n-care-products
  Forum: By Share Code

Frogster
Posted on: Jul 12 2017, 03:52 PM


Group: Member
Posts: 517

Yes, very cold goat's cheese.
  Forum: By Share Code

Frogster
Posted on: Jul 11 2017, 01:44 PM


Group: Member
Posts: 517

It's even older than that!

The you tube link posted by PortugueseMan dates it at 25/3/2011, which makes sense when you realise that the discussion focusses on how to get involved in the CUV101 trial. That trial was approved by the FDA on 3/3/2011.

I guess the blog needs to generate more traffic, hence the rehashing of the old, old, old stuff.
  Forum: By Share Code

Frogster
Posted on: Jul 8 2017, 12:35 PM


Group: Member
Posts: 517

Oooops. Missed the point of your post first time round xlnja. Ignore the spurious direction of my last post please.
  Forum: By Share Code

Frogster
Posted on: Jul 8 2017, 11:50 AM


Group: Member
Posts: 517

If the corporate webpage is the shop window to the world, then CUV comes across as an op-shop with white washed glass.
  Forum: By Share Code

Frogster
Posted on: Jul 7 2017, 05:48 PM


Group: Member
Posts: 517

But it does......albeit only in passing.
  Forum: By Share Code

Frogster
Posted on: Jun 26 2017, 01:19 PM


Group: Member
Posts: 517

If you are asking about the source of the 3 quotations in RC's post that you replied to, they're all factual data points and commentary from the journal article that he linked to in the same post.
  Forum: By Share Code

Frogster
Posted on: Jun 23 2017, 09:28 PM


Group: Member
Posts: 517

AWMSG appraisal meeting now set for 13/9/17.

http://www.awmsg.org/awmsgonline/app/appraisalinfo/634
  Forum: By Share Code

Frogster
Posted on: Jun 23 2017, 04:31 PM


Group: Member
Posts: 517

For us non German speakers, what does it say please?
  Forum: By Share Code

Frogster
Posted on: Jun 21 2017, 10:37 PM


Group: Member
Posts: 517

"You can't expect them to be perfect but ... if you say something publicly, you have to do it, that's my genuine view, and if that's not happening within any organization then there needs to be change. "

Hmmmmmm. Turn that view back on yourself and Clinuvel, Mr Hay.
  Forum: By Share Code

Frogster
Posted on: Jun 21 2017, 10:10 PM


Group: Member
Posts: 517

Thanks very much newtocli. Can i ask where the German EPP detail came from? Would love to know.

Is anybody else slightly disgusted by the fact that we learn about a potential 6 month NDA delay through a subscription only publication? I wonder how that squares with ASX continuous disclosure requirements? Communication fail, yet again.
  Forum: By Share Code

Frogster
Posted on: Jun 19 2017, 09:00 AM


Group: Member
Posts: 517

Very nice find Farma, but can you explain what makes you think it is again up for appraisal again on the 21 June?

I get that it was set for then, but nothing suggests to me that it still is given Kalydeco is on the list as of the latest agenda.

I notice that the minutes that initially suggest we'd be assessed on 21 June are themselves dated 26 April.

It was 2 May that Clinuvel told us that we were back in the NICE HST assessment stream. I wonder if, once the HST assessment was agreed to, Clinuvel pulled the AWMSG assessment?

Your second post from yesterday included the text "AWMSG will not normally consider appraising a product if NICE intends to publish their final appraisal of the same product within 12 months of the date of marketing authorisation."

It's not clear to me if "marketing authorisation" refers to the original EMA approval, or if it's referring to local NICE/AWMSG decisions, but if it's the latter then maybe it was AWMSG which bumped the appraisal since the HST evalution is due in less than 12 months (23 May 2018).

Speculation here on my part, but what do you think?
  Forum: By Share Code

Frogster
Posted on: Jun 16 2017, 06:32 PM


Group: Member
Posts: 517

In my view that quotation from Dr Grimes doesn't prove any specific, detailed, advanced knowledge of the CUV103 results. Almost everything stated by the Dr in that article was already in the public domain.


On 3/12/15, as I mentioned earlier, CUV published "positive preliminary CUV103 results" which were "consistent with CUV102 results":
http://clinuvel.com/investors/news/item/49...-vitiligo-study


On 3/8/16, the day before that Dermatology Times article was published (i.e. it's an old article), CUV issued another release in which they spoke about preparing an EPP NDA, but they also reiterated the positive preliminary results from CUV103 and discussed the need for a type C FDA meeting to plan for the next North American vitiligo trial. This built upon the 2015 AGM (page 33) comments where they stated "the strategy for vitiligo is taking shape and will depend on the results from CUV103.........the program illustrated (2 North American Phase 3 trials) is the expected program, while it is also possible that the program is reduced to one Phase 3 trial":
http://clinuvel.com/investors/news/item/49...ination-therapy


As such, the only speculation made by the Dr is that the trial would start in 2017 (next year from 2016) and that doesn't seem unreasonable.


Like RC, I expect CUV is holding CUV103 results back till at least the EPP NDA is made. Thereafter I hope the phase 3 vitiligo trials will happen sharpish (lets hope we don't have to wait till any actual approval is received).

Having said all that, yes, I damn well hope CUV is already in regular contact with US dermatologist ahead of FDA EPP approval!
  Forum: By Share Code

Frogster
Posted on: Jun 16 2017, 12:14 PM


Group: Member
Posts: 517

3/12/15 asx release of preliminary cuv103 results confirmed pilot study results. We've been waiting for final results for sometime now!

Clinhope, yes US phase 3 has been on the cards for a while. I think it was 2015 agm the talk of probable path to market was 2 concurrent phase 3 trials.

On my phone, otherwise would post links to both of the abive.
  Forum: By Share Code

Frogster
Posted on: Jun 16 2017, 09:28 AM


Group: Member
Posts: 517

Not sure there's anything substantially new for us in this (only skim read it), but there is a reiteration of afamelanotide as being a promising treatment for vitiligo (sorry, can't paste the whole thing):

Journal of the American Academy of Dermatology

Volume 77, Issue 1, July 2017, Pages 17–29

Current and emerging treatments for vitiligo



Extract:
Key points

•Afamelanotide enhances the efficacy of NB-UVB in patients with vitiligo

•Targeted immunotherapy has been safe and effective for psoriasis, and a similar treatment strategy may be equally beneficial for vitiligo patients

•The interferon-γ-CXCL10 chemokine axis appears to be an important target for the development of new treatments for vitiligo



α-Melanocyte-stimulating hormone analogues

Afamelanotide is a potent synthetic analogue of the naturally occurring α-melanocyte-stimulating hormone. It was investigated as an adjunct to NB-UVB in a double blind, multicenter study. Patients treated with NB-UVB plus afamelanotide versus NB-UVB alone achieved repigmentation rates of 48.64% and 33.26% at day 168, respectively. Side effects included hyperpigmentation, itch, and nausea. Additional studies with this promising treatment are warranted.

  Forum: By Share Code

Frogster
Posted on: Jun 15 2017, 09:16 AM


Group: Member
Posts: 517

Could this SIK inhibitor be an opportunity for CUV?

From the last newsletter:


In the coming months CLINUVEL will unveil its adapted business model, expanding the Group beyond SCENESSE®. It has long been our wish to grow the Company beyond more than one commercial asset. The prerequisite was to identify, reinforce and test our core competences to appraise the directions in which we could grow. Analogous to the past years, we wish to minimise the risk of entering new fields and markets while making sure pilot schemes provide us the necessary confidence and feedback on the feasibility of further growth.


So we know they want to expand into complementary areas. We know they are happy to licence tech from universities. We know they know more about skin than most. Maybe they see a therapeutic benefit in this technology that would complement rather than compete with Scenesse? Could there be a licensing opportunity? The paper did strike me as something of a shop window move.

What do you all think?
  Forum: By Share Code

Frogster
Posted on: Jun 14 2017, 07:52 AM


Group: Member
Posts: 517

Scientific stuff (link to the full paper):

http://www.cell.com/cell-reports/fulltext/...1247(17)30684-8


Non scientific stuff (links to press reports similar to the BBC one):

http://www.bostonmagazine.com/health/blog/...gh-dana-farber/

https://www.theguardian.com/society/2017/ju...nst-skin-cancer

http://www.sciencemag.org/news/2017/06/cou...tan-without-sun

https://www.livescience.com/35070-new-drug-...ns-the-sun.html
  Forum: By Share Code

Frogster
Posted on: Jun 12 2017, 04:19 PM


Group: Member
Posts: 517

Well in that case.......and I hope I am proved wrong, and that we are currently at the nadir of management's timeline credibility.
  Forum: By Share Code

Frogster
Posted on: Jun 12 2017, 03:32 PM


Group: Member
Posts: 517

Can we have a category for sincerely hope it will be lodged by 30th June, but, based on observations of past achievements, wouldn't be entirely surprised if this deadline was also missed?
  Forum: By Share Code

Frogster
Posted on: Jun 1 2017, 06:16 PM


Group: Member
Posts: 517

On some of the items we've covered, I'm not sure our collective understanding of how Clinuvel applies certain accounting rules has advanced alot today. More stuff to add to the list of questions when we get the chance. In the meantime, thanks for the discussion.
  Forum: By Share Code

Frogster
Posted on: Jun 1 2017, 02:32 PM


Group: Member
Posts: 517

ajshare: AASB 18 states that 5 criteria must be met before revenue (sales) are recognised (see my earlier post). The first of these is that the risks and rewards of ownership have been transferred to the buyer. I'm not sure how that criteria could be met without delivery having taken place. Also, you may well be correct that revenues of 4-6m with easily be done this quarter, but the point is slightly moot because (engage broken record) all we are given on a quarterly basis is cash receipts NOT revenues (which we only get every 6 months) so we will never know what revenue we get this quarter.

heckekjohn: interesting question about exactly "when a sale is made".

The notes in the AR state that:

"Revenue from reimbursement of implant sales from insurance companies is recognised when the consolidated entity has transferred to the buyer the significant risks and rewards of ownership of the goods."

I think a couple of things of interest flow from this:

- (as above) how can the rewards of ownership be transferred without delivery having been made?
- insurance companies are seen as the buyer from an accounting point of view, even though they are not the party that gains direct utility from the actual implants (i.e. they are not the patient).

So, to your first question, my understanding is that revenue would be recognised before the implant is actually inserted because it's the transfer to the insurance company that is the economically important point.

To your second question, is it possible they are administering implants whilst negotiating payment? I'd say yes, it's possible, as in it's physically possible to do so (but I have no knowledge that they actually are doing this). However, such action shouldn't lead to revenue recognition. Why? Well, as before AASB requires 5 criteria to be met before revenue is recognised (CUV lists the first criteria in the AR, but the fact that they don't list the other 4 doesn't make them disappear). One of those criteria is that "It is probable that the economic benefits from the transaction will flow to the entity". If you are still in negotiations with your customer about payment amounts and terms, I think it'd be a brave auditor who'd accept this criteria was met. Therefore a sale would not be recorded. i.e. if you are unsure you will be paid, it's not a sale till you are.
  Forum: By Share Code

Frogster
Posted on: Jun 1 2017, 09:25 AM


Group: Member
Posts: 517

Prior to the last 4C I was assuming that Trade Receivables were on the same payment terms as Trade Payables. The AR states that Trade Payables are generally on 30 days, and, in the absence of an explicit policy, it seemed reasonable to assume the same for Receivables.

A comment from RVBird on HotCopper started me thinking otherwise (thank you RVBird), and my thinking now goes like this:

Note 4 of the 2016 AR presents a table detailing the ageing of trade receivables. These are split into amount impaired and amount not impaired, and further categorised by time. The time categories are 1) Not past due 2) Past due 61-90 days 3) Past due>90 days.

The phrasing is a bit ambiguous:

Not past due - clear, not ambiguous
Past due 61-90 days - does this mean past due by 61-90 days, or does it mean 61-90 days past the date the receivable was generated?
Past due>90 days - similar to the 61-90 question

If the dates referred to days past due then for the table totals to be complete and accurate there should be data for "Past due 1-60 days" but there isn't. Therefore, it seems to me, the dates must refer to days since the receivable was raised.

If 61 days (and more) is considered past due, then 60 days (since generation) is not considered past due.

This suggests to me that standard trade receivable terms from Clinuvel are probably closer to 60 days than the 30 days I previously assumed. If this is the case then the recent disappointing 4C showed us the cash receipts from sales made in Nov-Dec-Jan, and the next one will show receipts broadly from Feb-Mar-Apr. (Oh, wouldn't it be nice if they had an IR function that would help clear these matters up........)


Separately, and it's been said before, there can be no delay between sales (revenues) being made and them being booked. June revenues will always be June revenues, but we won't see the cash receipts from them till next next fiscal year (and this is of course what the 4C shows use). Below is a post of mine from last December highlighting, from an accounting point of view, what actually defines a sales (or revenues). The summary is that revenue should be recognised when goods are shipped to customers who are likely to pay.


*******************************************

According to AASB 18 Revenue, each of the five criteria must be met in order to recognise revenue from the sale of goods:
  1. The significant risks and rewards of ownership have been transferred to buyer
  2. There is no continuing managerial involvement or effective control over goods transferred
  3. The amount of revenue can be measured reliably
  4. It is probable that the economic benefits from the transaction will flow to the entity
  5. The costs incurred or to be incurred in respect of the transaction can be measured reliably
So what that says, basically, is that they can book revenue (sales) in the P&L when they have transferred the product to the customer, and they are reasonably sure that customer will pay. So, revenue should NOT be recognised simply when an order is placed, but only after it has been delivered, but it CAN be recognised before the goods are paid for, as long as the certainty of payment is high.

Having said that, what we see in the Quarterly 4C is not revenue (sales) - it is Receipts i.e. actual payment for goods from customers. The quarterly is a cash flow statement, and NOT a P&L. So the receipts we see in the 4C are lagging the actual orders and sales by some time. By exactly how long is unclear. The AR states that trade creditors are typically paid on 30 day terms, and you wouldn't want customers paying any slower that you have to pay your suppliers, so it might be reasonable to assume Clinuvel also expects customers to pay within 30 days.

The (unknown) terms of customer payments has implications for how much we'll see from Germany in the next 4C. I think there's a chance it won't be much, but that will be due to accounting quirks as described and, therefore, wouldn't worry me since we'd see it all the next time.
  Forum: By Share Code

Frogster
Posted on: May 31 2017, 10:39 AM


Group: Member
Posts: 517

Interesting. Thanks.

I have a basic (but genuine) question: do the Modules have to be submitted in sequential order?
  Forum: By Share Code

Frogster
Posted on: May 28 2017, 02:38 PM


Group: Member
Posts: 517

In Reply To: PunkassDerm's post @ Apr 28 2017, 11:34 AM

His position and standing does remind me somewhat of that of Arsène Wenger.

Maybe the current quarter is his do or die FA cup final.

_________________________________________________________________

Well, Arsenal won 2:1, so that must surely auger well for PW and us longs.

:-)
  Forum: By Share Code

Frogster
Posted on: May 26 2017, 05:58 PM


Group: Member
Posts: 517

https://www.youtube.com/watch?v=wcsHEZS9jHI
  Forum: By Share Code

Frogster
Posted on: May 23 2017, 04:10 PM


Group: Member
Posts: 517

NICE has given a bit more timetable detail for the HST process in England. You can find that here:

https://www.nice.org.uk/guidance/indevelopment/gid-hst10009

It has also published a few documents around the assessment (interested parties matrix, their various comments on the draft assessment scope, and the final scope of the assessment (post comments). You can find these here:

https://www.nice.org.uk/guidance/indevelopm...10009/documents



A few comments from the comments table that I found especially interesting were:

TIMING ISSUES
British Association of Dematologists
URGENT; progress needs to be made as rapidly as possible to alleviate the considerable suffering of EPP patients.

Royal College of Pathologists
From the patients' perspective this evaluation is urgent as they have been aware of the innovative treatment for several years.......for most EPP patients there is currently no effective treatment option......

Royal College of Physicians
Urgency is medium - the aim of the treatment is to improve quality of life but it is not a life-saving treatment.

BPA
Until now, no effective therapy for EPP has bee available.

BACKGROUND INFORMATION
Royal College of Physicians
The estimate of 325 EPP patients in England derived from a 2006 study is a significant underestimate......More recent literature.....would suggest over 1000 cases in England.....

TECHNOLOGY/INTERVENTION
BPA
the testimonies of EPP patients and medical experts should have the highest weight.

COMPARATORS
BAoD
no effective treatment currently

RCoPh
The best alternative care is probably narrow ban UV-B therapy

BPA
Afamelanotide appears to be the only treatment to effectively work to prolong the time people can spend in the light. It is very difficult to compare Afamelanotide with any other treatment (including UV-B) as there is no resaerch to provide a comparison.

OUTCOMES
BAoD
There is a consensus in the porphyria academic and clinical community that outcomes measured in trials have underestimated the therapeutic effects significantly.

INNOVATION
BAoD
Yes it is a step change - it is the first effective treatment in EPP

RCoPa
Yes

RCoPh
Probably

BPA
Yes, it is a step change in the management of EPP

OTHER CONSIDERATIONS
RCoPH
It would be useful to examine the individual raw patient data from the trials....and to repeat the statistical evaluation.


There's a big heap of further comments too, but I thought the above were most useful.

So, in summary, you might say that the British Association of Dermatologists, the Royal College of Pathologists, and the British Porphyria Association are highly supportive of Scenesse as being innovative, effective and urgent, whilst the Royal College of Physicians is also supportive, albeit in a slightly more moderate manner.

They do, however, believe there could be over a 1000 cases of EPP in England alone.
  Forum: By Share Code

Frogster
Posted on: May 22 2017, 02:08 PM


Group: Member
Posts: 517

Yeah, I get that, but you're talking only from the point if view of the Dr.

My comments were reflecting what the supplier has directly told us - that distribution mechanisms in the US will be similar to those in Europe which have been designed, in part, to prevent off label use. Maybe it will intially be a specialist hospital only product like in Europe? Available only though specialists?

If, legally speaking, any US non specialist MD is able to prescribe any drug then I don't know how CUV would handle the prescriptions but Wolgen has suggested it's not likely to be a free for all. Maybe that is just his public stance, and privately the view is different. Who knows?

To be clear, I do fully expect, over time as the drug is priven safe time and time again, as wider indications are applied and as cheaper delivery methods are developed then I sure off label will grow. I'm just not expected it to be a big thing straight off the bat. To be clearer still, I'm not talking this down. Full access to EPP patients in the entire US is still huge for us!
  Forum: By Share Code

Frogster
Posted on: May 22 2017, 10:04 AM


Group: Member
Posts: 517

Just to temper off label use expectations a little, the Walnutmeister mentioned at the AGM that EPP in the US will see a similar post marketing plan as applied in Europe including using "the same disease registry".

He also mentioned that off label use in Europe will not be possible, and that this is being carefully scrutinised by the EMA (as we know) but also by the FDA.

So, for me, the controlled distribution system will limit off label use at least in the first instance.

With yet further proof of safety I'd expect this would open up as other indications come online. I can't see that a vitiligo registry with full follow up in the style of the Euro EPP set up would be possible. Vitiligo treatments would need to be cheaper and easier, and with that, IMHO, you'd get a massive increase in off label application. So, as with all things Clinuvel, time is the key factor. Whilst EPP is the only indication in the US, I think off label use would be very small.
  Forum: By Share Code

Frogster
Posted on: May 20 2017, 05:18 PM


Group: Member
Posts: 517

You are setting yourself up for a disappointment.

There are 28 EU members states, and Clinuvel is targetting sales in 15-17 of them (source, 2016 AGM).

The only one that I know of with a published assessment timetable is the NICE assessment in England. Their review will be published in May 2018.

Clinuvel will not have the green light for sales in every member state this year, or, for the foreseeable future.

In years to come, as the product portfolio matures and pricing comes down significantly, I could imagine the uniform asking price might drop significantly enough such that the EU member states with more limited economic resources might also be targetted, thus expanding the number beyond 15-17.
  Forum: By Share Code

Frogster
Posted on: May 16 2017, 03:37 PM


Group: Member
Posts: 517

No. I think that's wrong.

EMA has essentially approved the safety and efficacy. NICE essentially makes a judgement on the economic value to England, as every European country will separately do for itself. These are not the same things, so a phone call won't fix it.

Your opinion that FDA/EMA/etc. etc. duplicate alot of work I'd agree with at a simplistic level, but perhaps you should let the argument go given that there is no way in hell that any changes in remit and responsibilities will be made by either major organisation whilst Scenesse is in the approval window.

Even a "tiny" approval org such as the TGA will take 12-24 months to change it's procedures and piggy back off EMA/FDA. How long would it take to negotiate arrangements between either the FDA or EMA? Decades??

Yes, in the end patients suffer and costs are (needlessly) increased, but as far as Scenesse goes, the point is moot.
  Forum: By Share Code

Frogster
Posted on: May 16 2017, 03:02 PM


Group: Member
Posts: 517

Looks like NICE has announced the expected publication date of its Scenesse review now that it's back in the HST approval stream as announced a few weeks back. It's now due on May 2018:

https://www.nice.org.uk/guidance/indevelopment/gid-hst10009

This is actually the same date as was expected when the product got shunted into the STA process:

https://www.nice.org.uk/guidance/indevelopment/gid-ta10117

So, it looks like the approval hasn't lost MORE time since being shifted back to HST than it lost being erroneously punted to STA and hopefully English patients will have access for their next summer.

By then the US will hopefully be underway, and Europe will hopefully be settling into a nice rhythm.

Hopefully.
  Forum: By Share Code

Frogster
Posted on: May 16 2017, 08:15 AM


Group: Member
Posts: 517

Not sure if this is what you are getting at or not, but in September last year the Aussie government announced it's response to a major review of regulatory procedures and part of that response was to accept the suggestion of opening a new pathway to registering a product in Australia by relying more heavily on approvals made by the FDA, EMA or equivalent authority. The expectation is that this could, in some circumstances, save a couple of years on approval timelines.

https://www.tga.gov.au/sites/default/files/...e-mmdr-2016.pdf

This, and various other changes, were expected to be implemented on a 12-24 month timeframe, so it's not in place just yet (as I understand) but given PW stated at the last AGM that TGA approval would be sought next in line after the FDA and Switzerland I suppose it's possible that Scenesse might be one of the very first product approvals sought under the new pathway in Aus.

Two wrinkles may affect the above. 1) since the response was announced Australia has a new Health Minister. Sussan Ley was judged by the public to have been doing something dodgy to feather her own nest at the expense of the tax payer, and she was forced to resign. She has been replaced by Greg Hunt. I'm not aware that he has a different stance on the official response, and indeed he seems to be quite a pragmatic man, so it's probably not too much of an issue. 2) The head of the TGA Prof John Skerritt has had a bit of press taking about the new pathway requiring "2 to tango" i.e. the TGA might be happy to use reports from other administrators, but they need to be happy to release them in full to the TGA, and changes in processes at other comparable authorities can make working out just who is comparable difficult (and of course the EMA and FDA are experiencing some changes right now). In summary, he's implied opening new the pathway isn't 100% straight forward.

My guess is that CUV would likely wait till the new pathway is open (possibly from September this year, possibly later) and seek fast approval under it rather than use an existing application pathway. I wonder if the preference would be to wait for a "standard" FDA approval response (if that's what we'd get) and use that rather than apply to the TGA using the "exceptional circumstances" approval from the EMA. That would obviously link the application timeline to the FDA approval timeline.
  Forum: By Share Code

Frogster
Posted on: May 15 2017, 02:00 PM


Group: Member
Posts: 517

Thanks for the sensible, logical, balanced, referenced and calm discussion guys. Great to see that there is still value to be had from this board.
  Forum: By Share Code

3 Pages (Click to Jump) V   1 2 3 >

Cant find what you are looking for? Show all active topics from the last 3 months


New Posts  New Replies
No New Posts  No New Replies
Hot topic  Hot Topic (New)
No new  Hot Topic (No New)



TERMS OF USE  -  CONTACT ADMIN  -  ADVERTISING