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FarmaZutical
Posted on: Dec 12 2018, 06:38 PM


Group: Member
Posts: 482

I actually hope we won’t hear anything from the FDA until sometime in January.
That would prove, that Dr. Wolgen was truthful and sincere in the newsletter where he
stated that Clinuvel didn’t receive an RTF. If the upcoming news coincides with the date
that - logically - would be the new day 74, it would disappoint me a lot.
  Forum: By Share Code

FarmaZutical
Posted on: Nov 28 2018, 08:00 AM


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Posts: 482

I’m surprised it’s not March 2020.
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FarmaZutical
Posted on: Nov 25 2018, 06:31 PM


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Posts: 482

Thanks a lot. We can’t know when Clinuvel applied for reimbursement in France but it seems that the average
time is 6 month for appraisal. April seems like a possible deadline unless they filed several months ago.
  Forum: By Share Code

FarmaZutical
Posted on: Nov 22 2018, 03:46 PM


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Posts: 482

Interesting article that seems to apply to our situation related to the manufacturing issue and current FDA delay.
The good thing is that they discovered the issue now so we are not getting a CRL on that basis later.

https://cen.acs.org/articles/95/i20/complet...r-mail-one.html
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FarmaZutical
Posted on: Nov 5 2018, 03:12 PM


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Posts: 482

This is probably the best written Clinuvel communique ever. Concise and easy to read as every PR ought to be.
Assuming that everything stated is true (the reason for the OTC delay seems odd) it actually answered all the questions
we have raised here. Most importantly, no RTF. It seems that Clinuvel together with possibly ICON answered all additional questions
and are now waiting for validation of the dossier if no further questions arise. I think we’re fine.

Bravo, Dr. Wolgen. And thank you.
  Forum: By Share Code

FarmaZutical
Posted on: Nov 1 2018, 04:07 AM


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Posts: 482

Could be the case. Product availability is one of the FDA is looking at.
You need to be able to prove that you can deliver a stable flow of finished product
to the assessed patient population. Does anyone know what the production cost per implant is?
  Forum: By Share Code

FarmaZutical
Posted on: Oct 31 2018, 09:58 PM


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Posts: 482

Those trials will only comprise a few handfuls of patients.
It would have to be something else, I think.
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FarmaZutical
Posted on: Oct 30 2018, 07:21 PM


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Posts: 482

I’ll go back and re-listen Dr. Wolgens presentation at the Nasdaq online event to
be 100 % sure. I remember I said it there.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 30 2018, 05:40 PM


Group: Member
Posts: 482

But will we get a clear answer to the question: “Was there a RTF or not?”
It takes a persistent investor to get an answer. Who’s going and who will do it ?
And who will be filming ?
  Forum: By Share Code

FarmaZutical
Posted on: Oct 30 2018, 05:16 PM


Group: Member
Posts: 482

This could be the case:

They decided to do an unjustified trade halt to get PR when they filed the last module of the NDA.
It would be very embarrassing and humiliating having to admit that the NDA was incomplete and that they received a RTF only weeks after.
Also, it would have jeopardized ASX300 inclusion at that time.

Therefore, Wolgen and Clinuvel lied about the real reason for the delay and they can’t dial the lies back now.

It would explain why they still expect the decision about Priority Review to be made after the FDA reviews
the requested info. Usually, that decision is made quite early in the validation period.

However, the company has also stated that they already delivered the additional information to the FDA and that they are now
waiting - and that the FDA has provided no additional timeline. That’s odd. Either they are lying or the FDA is handling their case
in a way that is highly unusual. My colleague who deals with the FDA told me that it’s not impossible that the FDA didn’t issue a RTF but it does seem very
strange. A normal company would issue a clear statement but all we get is misleading bs PRs in the form of eassays.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 29 2018, 03:40 PM


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Posts: 482

What a nonsensical crap PR. Doesn’t serve any purpose.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 29 2018, 07:33 AM


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Posts: 482

What ever happened to the news about Vallaurix that was supposed to be know before annual report was out?
Boy, they really know how to mess up even the simplest communication task.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 20 2018, 07:37 AM


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Posts: 482

5 years aligns fine with HHD but my guess is that they are aiming for XP. Clinuvel want to establish themselves as leaders in optical physics and photo protection and HHD doesn’t fit very well in that branding strategy. They long term goal has always been to develop a general protectant against skin cancer. XP fits much better as a stepping stone to reach that goal eventually. HHD would be a lucrative opportunity short to medium term but in the long run XP is much more valuable because it adds to the strategy that began with EPP.

I think HHD will be one of the indications that will be perused down the road but first we need to build a portfolio that is narrowly dealing with photopeotection. Hence also the focus on OTC cosmetics.

Just my guess.
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FarmaZutical
Posted on: Oct 18 2018, 07:05 AM


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Posts: 482

I had a chance to discuss the possible RTF situation with a colleague who deals with the FDA all the time. He says it’s not common
to ask for additional data the way it’s happening now during the validation process. On the other hand, orphan and rolling cuts us some slack.
It seems there might not be issued an RTF and that the FDA is causing the delay - not Clinuvel. The FDA is overburdened right now and even
though Clinuvel filed the additional data the FDA may not have the capability to review it in a timely manner. That could be the reason for no RTF.
The bad news is that it can take months to review and validate especially the manufacturing process if the FDA found a small issue they want clarification on.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 16 2018, 06:51 PM


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Posts: 482

Simply correcting the sloppy work by Rachel Jones in the first segment and article. They fixed the article
and erased the filmed segment. Normally, you would apologize and make the reader aware that the media
published false information. It seems these guys just bury it.
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FarmaZutical
Posted on: Oct 13 2018, 04:27 PM


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Posts: 482

That should be NO bylines.
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FarmaZutical
Posted on: Oct 13 2018, 08:17 AM


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Posts: 482

I’m almost certain that Giles Delaney doesn’t exist. Any experienced journalist would show up in a Google search.
There are no articles by him anywhere. My bylines. Besides that the content on Clinuvel’s website is so weird. Clinuvel
should not be a MySpace for obscure journalists.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 12 2018, 05:13 AM


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Posts: 482

Clinuvel isn’t going to get a voucher. They might get priority review but that can’t be sold off.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 12 2018, 05:12 AM


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Posts: 482

We should get drunk together some day. We could write a book :-)
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FarmaZutical
Posted on: Oct 12 2018, 02:18 AM


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Posts: 482

I concur. But what puzzles me is that the chair even said that the recent request for additional data was “expected.” Why would they expect
an RTF ? Again, either they lie or there is a loophole in the rules that I haven’t seen applied before.

Also, they pulled a trade halt on us when they lodged the final module. Therefore, I would think
that it is a material event when they receive an RTF and hence something they are obliged
to communicate.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 11 2018, 11:04 PM


Group: Member
Posts: 482

I’m very puzzled about this, as well. Logically, Clinuvel received an RTF and will have to re-file.
However, during the presentation the CEO said that the FDA would decide on a PDUFA “shortly.”
The way the company has presented the delay does not at all infer an RTF.
Either the company is disingenuous, which wouldn’t be the first time, or the FDA
is bending a lot of procedural rules to accommodate Clinuvel.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 10 2018, 01:48 AM


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Posts: 482

In any case, I expect the reassessment to take between 8-12 months so we might even be past FDA PDUFA before hearing anything from NICE again. American EPP patients are likely to get access to Scenesse well before British sufferers.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2018, 04:44 PM


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Posts: 482

Which is why it makes perfect sense with Mr. Blijdorp as our future chair:

“Being recognised for his expertise in merger and acquisitions and leadership, in 2014 Mr Blijdorp was awarded the Ernst & Young Entrepreneur of the Year in the Netherlands.”

They want Wolgen to stay on till 2021. What happens in 2021 ? (Cue drumroll).
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2018, 02:03 PM


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Posts: 482

On the positive side I think this one is significant:

“it was unreasonable for the committee to state that the trial results show small benefits“

However, some of the other important appeals were dismissed.

It’s great that some of the appeals were upheld and that it now goes back to the NICE committee,
but will it be enough to change the outcome? I don’t know.
  Forum: By Share Code

FarmaZutical
Posted on: Oct 9 2018, 01:53 PM


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Posts: 482

NICE appeal decision:

https://www.nice.org.uk/guidance/gid-hst100...appeal-decision

Conclusion and effect of the appeal panel’s decision
121. The appeal panel therefore upholds the appeal on the grounds IPPN 1a.1, CLINUVEL 1b.1, IPPN 1b.1, BAD 2.2, BAD 2.3, IPPN 2.2. The appeal is dismissed on all other grounds.
122. The evaluation is remitted to the evaluation committee who must now take all reasonable steps to address the following issues:
i) The failure to include an IPPN representative at the second committee meeting (IPPN 1a.1).
ii) The failure to demonstrate adequate consideration of the legal duties and obligations placed on it as a public authority under the Equality Act (CLINUVEL 1b.1 and IPPN 1b.1). The appeal panel considers that this is likely to include express consideration of whether the methodology used in the evaluation discriminates against patients with EPP and if so what reasonable adjustments should be made.
iii) The appeal panel's conclusion that it was unreasonable for the committee to state that the trial results show small benefits with afamelanotide (BAD 2.2 and 2.3, IPPN 2.2).
123. There is no possibility of further appeal against this decision of the appeal panel. However, this decision and NICE’s decision to issue the final guidance may be challenged by applying to the High Court for permission to apply for a judicial review. Any such application must be made within three months of NICE publishing the final guidance.
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FarmaZutical
Posted on: Oct 1 2018, 01:34 PM


Group: Member
Posts: 482

Choosing VP as the new orphan indication is a brilliant move. I was expecting XP, but this makes much more sense from a business perspective.
First, they will use the established framework of the EPP centers in Europe to conduct the trial(s). Likely, they will do the same in the US for the pivotal
phase 2/3 or 3 that will follow the initial 2a. This is less costly and scientifically easier than stating all over in XP where they have
no network yet. If they follow the same strategy, they will probably initiate XP trials in Japan once Scenesse
is approved for EPP there in a year to two.

Also prevalence is much higher for VP than in XP. VP = 1:100.000 (much higher in South Africa) and XP 1:1.000.000.
That gives us at least app. 6000 patients in Europe and 3000 in the US. 15.000 in South Africa.

They will dose VP patients every 28 days mirroring the dosing cycle in treating Vitiligo. It seems they plan to use
the data collected during the upcoming VP trials to also support the future NDA for Vitiligo. Smart move using synergies.

Even if they cut the price per implant down to $6000 that’s a very significant business case. We don’t know how many implants
they plan to administer yearly to VP patients but let’s assume 6 to be conservative.

Uptake will probably be fairly high since there is no alternative, so let’s assume we can treat 4000 patients in Europe and 2000 in the US
which is probably still conservative.

6000 patients paying 6000 USD 6 times a year = 216 m. USD. In my book that represents <60 USD pps. Add South Africa and that number
explodes but I will leave that out for now. Also, they may not lower the price per implant at all and then my numbers double (!).

Add EPP at the new lower price per implant administered 6 times a year (which is probably coming up) to 3000 patients coming up
and that’s 108 m. USD = < 30 USD. Add Australia and Japan and the number is even higher.

VP and EPP combined represents a future share price of 100 USD at the very least. 150 - 200 USD if they don’t lower the implant price.

The FDA and EMA are very likely to approve an sNDA and I expect the best possible scenario is a PDUFA for VP sometime in 2021 but
already now it should represent a risk weighted value of somewhere between 10-30 %. If they show good results in the phase 2a
which I expect they will the value will be higher also given the fact that the likelyhood of regulatory approval is extremely high for
a second indication.

At the current price per implant stand by my previous calculations and think that EPP is worth at least
50 USD in Europe and the US combined short to medium term. That number will go down if they lower the price per implant, of course.

I’d say that neither Vitiligo nor any of the other opportunities are reflected in today’s pps. Enfance, topicals etc. Right now, the pps
merely reflects the opportunity for EPP in Europe and we’re still on the very low side. VP ought to add a few Bucks today and 5-10 USD when the market realizes that it’s
a less risky endeavor than gaining regulatory approval for a new drug.

There’s still a lot of work to be done and it will be interesting to follow the work with VP and hopefully soon also Vitiligo.

My 12-18 months target is 50 USD. By then, we are either approved in the US or very close to be approved. VP trials
have hopefully been successful in Europe, the cosmetic line is underway, Vitiligo is revived, regulatory approval in Australia and
Japan is underway and Enfance for treating the pediatric population is hopefully also moving along.
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FarmaZutical
Posted on: Sep 27 2018, 10:23 PM


Group: Member
Posts: 482

62 USD plus shares in the acquiring company.
The value of EPP in the US and Europe plus a 25 % premium.
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FarmaZutical
Posted on: Sep 26 2018, 07:51 PM


Group: Member
Posts: 482

It says something about management’s shares being taken out of the calculation when determining the market cap neede for the ASX200.
Do you know more about this and if that changes anything for us ?
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FarmaZutical
Posted on: Sep 9 2018, 08:25 PM


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Posts: 482

It seems Clinuvel deleted the two Facebook pages for Chivére and T’sumoyle.
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FarmaZutical
Posted on: Sep 7 2018, 06:56 PM


Group: Member
Posts: 482

New investors and funds,

Welcome to the Clinuvel family. Now that we’re getting new cousins
as part of the ASX300, you might want to know some more about
us. This analyst report is the best way to get to know us:

http://www.sharescene.com/index.php?act=at...st&id=49929

Sincerely,

Uncle Farma
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FarmaZutical
Posted on: Sep 7 2018, 04:44 PM


Group: Member
Posts: 482

Thanks a lot. Can you post the pdf again ? Didn’t seem to be attached.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 5 2018, 05:07 PM


Group: Member
Posts: 482

Feel free to do so 🙂
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FarmaZutical
Posted on: Sep 5 2018, 04:21 PM


Group: Member
Posts: 482

I share your frustration and you’re right in many ways.
But it could in fact be a 23 year old FDA inspector who’s
causing the RTF.

Once Clinuvel submitted the application the review team received
the different modules and started determining wether to validate or not.

The deficiencies might be enough to cause a delay but I’m not
overly concerned that this ties into the overall push back against Scenesse.

  Forum: By Share Code

FarmaZutical
Posted on: Sep 5 2018, 03:28 PM


Group: Member
Posts: 482

Clinuvel has received a refusal to file letter - RTL

They received this information no later than 60 days
after submitting the NDA; hence August 22nd or 23rd.

They deliberately held this information back from the market until
now unless the FDA is in violation of its own rules to communicate
the RTF within 60 days after submission.

It could be, that Clinuvel was hoping to buy some time
while submitting the additional information.

But could it also be that a drop in SP two weeks ago would
have impacted ASX300 inclusion negatively and therefore
they kept the market in the dark making us think we were waiting for
the day 74 letter ?

In any case, the information that the FDA requests is not catastrophic.
RTFs have increased over the past years and have no impact on wether
the FDA is likely to approve the NDA or not when the deficiencies are corrected.

As I mentioned many times:

Rolling review is not a rolling review.
Fast track is not fast.
Priority review says nothing about approvability.

But also:

A RTF is not catastrophic
A CRL does not mean that the NDA can’t be approved at a later stage. Sometimes within only days or weeks after the CRL.

Come on Clinuvel. Play by the book and get this solved by tomorrow.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 5 2018, 05:32 AM


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Posts: 482

That’s a very modest wish :-)
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FarmaZutical
Posted on: Sep 5 2018, 02:55 AM


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Posts: 482

A friendly word of caution: Hybris is a bitch. And I’m superstitious.
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FarmaZutical
Posted on: Sep 4 2018, 03:59 PM


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Posts: 482

“Would you not think the “rolling review” process was a complete sham and a total waste of time and effort if Scenesse was to be rejected?”

Yes and no. From a personal standpoint, yes. But when you know how the FDA operates, no.
Rolling review is in its essence more about frequent communication between the sponsor and the FDA more so
than being an actual review of the modules as they roll in. Upon lodging the final module of the NDA all the modules are sent
to the proper offices within the division and first then, begins the actual validation and subsequent review. During the review there might
be an adcom. That’s also a potential pitfall. And the FDA makes it very clear that fast track, rolling review, priority review and all the other
paths don’t equal a better chance of approval.

Do I think it’s fair to assume and to I hope that our situation bodes well for approval? Yes indeed.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 4 2018, 02:57 PM


Group: Member
Posts: 482

It’s very important to remember that priority review does not equal certain approval of the NDA.
I’m not saying this to downplay how awesome it would be to get priority review but merely
to emphasize that NOT getting priority review does not equal a lower chance of approval, either.
In both scenarios the chances of approval are very high and just having the NDA validated
is a tremendous step forward.
  Forum: By Share Code

FarmaZutical
Posted on: Sep 2 2018, 02:13 AM


Group: Member
Posts: 482

If the division ever had a valid reason to grant priority review it would be now.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 31 2018, 09:02 PM


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Posts: 482

It’s 14 calendar days.
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FarmaZutical
Posted on: Aug 31 2018, 12:40 AM


Group: Member
Posts: 482

Scenesse is reviewed by the dental and dermatology division.
Attached thumbnail(s)
Attached Image


 
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FarmaZutical
Posted on: Aug 30 2018, 03:04 AM


Group: Member
Posts: 482

I know that you're a seasoned bioinvestor so you probably know the procedure and suggesting an RTF just because we haven't heard from them yet is not fair.

The validation period is 60 days, indeed. But the timeframe for the Day 74 letter is an addtional 14 days. Most recently, Evoke Pharma got their Day 74 letter two weeks after the validation period which is normal.

I'm sure we will hear from the company on the day (or the following Australian time) they receive the Day 74 letter. We may not get priority review but we will live without.

As for the 24 months review timeframe it's correct that the derma divison of the FDA is known for slower reviews and 24 months is not unusual. Again, your attack is not totally fair.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 30 2018, 12:09 AM


Group: Member
Posts: 482

But there will be. I’m just curious as to how Clinuvel will react. Probably not
a bad idea to remain on the ASX right now.
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FarmaZutical
Posted on: Aug 29 2018, 05:59 PM


Group: Member
Posts: 482

Many interesting points. One of which is him talking about an end game which according to this could be
as near as 2021. I wonder what their internal plans for an “end game” are. I would love to see Mr. Blijdorp as new chair.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 24 2018, 02:34 PM


Group: Member
Posts: 482

It can take longer. Most recently, Starpharma announced the submission of their final module on April 30th. The FDA
validated the NDA on July 9th and confirmed priority review. That’s 60 + 10 days and within the day-74 limit.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 23 2018, 06:35 AM


Group: Member
Posts: 482

It seems increasingly likely that Chivére and Tsumoyl are indeed CUV009 and VLRX001 and not the new cosmetics as I thought.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 22 2018, 05:03 AM


Group: Member
Posts: 482

Yes, but after 2016: "Since then..."

"Scenesse was approved by the European Medicines Agency (EMA) for the prevention of phototoxicity in adult patiens with EPP in December 2014, with the first patients receiving the drug under the marketing authorisation in June 2016. Since then CLINUVEL has facilitated the treatment of EPP patients in six EU countries...."


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FarmaZutical
Posted on: Aug 22 2018, 04:24 AM


Group: Member
Posts: 482

Another question: Which are the last two of the six EU countires they are referring to ?

Netherlands, Germany, Austria, Italy, ????? and ??????
  Forum: By Share Code

FarmaZutical
Posted on: Aug 22 2018, 03:21 AM


Group: Member
Posts: 482

The deadline for validation is tomorrow but the FDA has another 14 days to communicate the decision to the sponsor. Hence, it's called a Day-74 letter. It might come earlier, though.

The recent PR seems like an attempt to put some informations out there about the company in anticipation of an imminent decision by the FDA that will, evidently, put Clinuvel in the limelight.

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FarmaZutical
Posted on: Aug 15 2018, 04:38 AM


Group: Member
Posts: 482

You're on to something.




Sumoylation is a covalent protein posttranslational modification that conjugates the small ubiquitin-like peptide SUMO to substrate. Sumoylation is critically implicated in multiple biological processes, including cell proliferation, differentiation, senescence and apoptosis, etc. Therefore, it is not surprising that dysregulation of sumoylation has been implicated in tumorigenesis and different types of cancer were found to be addicted to functional sumoylation pathway. The potential role for sumoylation as a therapeutic target in caner is emerging.


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FarmaZutical
Posted on: Aug 14 2018, 04:47 PM


Group: Member
Posts: 482

Both Chivére and now also Tsumoyl are now registred trademarks.

https://www.trademarkia.com/ctm/tsumoyl-017877352.htm
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FarmaZutical
Posted on: Aug 9 2018, 02:36 AM


Group: Member
Posts: 482

Either Clinuvel is applying extra pressure while the appeal committee is
preparing its decision or the appeal was dismissed and they are
now venting their frustration on instagram.

I expect they will take it to High Court if it is dismissed.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 9 2018, 12:49 AM


Group: Member
Posts: 482

Wauv
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FarmaZutical
Posted on: Aug 8 2018, 06:07 PM


Group: Member
Posts: 482

To add to your list: Japan and Australia. Combined 150 m. population and 500-1000 potential EPP patients.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 7 2018, 06:05 PM


Group: Member
Posts: 482

Although the deadline for validation is August 22nd we might get to wait another 14 days.
The FDA has 14 days to let the company know wether the NDA is validated or not. Hence, it’s called a 74-day letter.
  Forum: By Share Code

FarmaZutical
Posted on: Aug 1 2018, 01:56 AM


Group: Member
Posts: 482

Many of my friends spend countless hours on watching baseball and other sports. I have to admit I don't care much for that. The time I spend on DD is less than what my friends spend on watching TV. I don't watch TV. They day Clinuvel is sold, I will have way too much time on my hands and the need for a new hobby. Perhaps a Sunseeker Predator 50 will do.


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FarmaZutical
Posted on: Jul 31 2018, 09:09 AM


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Posts: 482

They are part of the appeal process.
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FarmaZutical
Posted on: Jul 31 2018, 07:50 AM


Group: Member
Posts: 482

Today, NICE published all the documents related to the appeal. It’s a real thriller.

This is the link to the main page where you’ll find everything:

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

In the company’s appeal letter, Clinuvel describes how a member of the committee is blatantly disqualified
as the company had discussions with him at an earlier stage about using him as a consultant. They turned down
his offer and had no idea he would turn up on the NICE committee. This is outrageous.

You’ll have a good hour of reading if you go throug all the documents.

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FarmaZutical
Posted on: Jul 30 2018, 08:07 PM


Group: Member
Posts: 482

From NICE homepage:

11.1 What is the timescale for the appeal decision?

In both the oral and written appeal processes, the Appeal Panel will aim to send its decision in writing to NICE within 15 working days of the appeal. There may be circumstances in which more time is needed. The appeal decision is then considered by the Guidance Executive. The Guidance Executive consists of the NICE Senior Management Team and is chaired by the NICE Chief Executive. Figure 3 summarises the appeal process from the release of the appeal decision to its publication as well as the publication of the guidance.

11.2 Outcome of an appeal

Appeal upheld and final draft guidance returned to the advisory committee

If 1 or more of the appeal points are upheld and it is necessary for the final draft guidance to be returned to the advisory committee, the Guidance Executive will aim to consider the appeal decision within 15 working days of receipt. The Guidance Executive will decide how to act on the decision of the Appeal Panel. The appeal decision is normally published within 10 working days of its consideration by the Guidance Executive. Consultees (including appellants) and commentators are informed of the appeal decision and details of when the final draft guidance will be reconsidered by the advisory committee, 2 working days before publication of the appeal decision.

The technology will be returned to the relevant programme and work will start on reviewing the guidance as advised by the Appeal Panel and agreed by the NICE Guidance Executive.

The advisory committee will meet to consider the Appeal Panel's decision for review. The advisory committee will then produce revised final draft guidance. When the final draft guidance is produced, it will be distributed to consultees and commentators. Consultees will then have a further opportunity to appeal or to identify any factual errors.

If an appellant from the first appeal lodges another appeal, the appeal letter must not raise the same points presented in the first appeal or those points presented by another appellant at the first appeal hearing. The Appeal Panel will have already determined the outcome on these points.

If an appellant who did not participate in the first appeal hearing lodges an appeal, the appeal will need to satisfy the Vice Chair of NICE that one or more of the grounds has been met and has a reasonable prospect of success. The appeal process will follow its usual process and continue as either an oral or written appeal.

Only points that directly relate to the aspects of the revised final draft guidance associated with the appeal decision will be considered.

Appeal Panel requests changes to the final draft guidance but no further consideration by the Committee

If the Appeal Panel asks the Guidance Executive to approve changes to the final draft guidance that do not require further consideration by the Committee, the Guidance Executive will aim to consider the appeal decision within 15 working days of receipt of the appeal decision. After the Guidance Executive meeting, editorial changes to final guidance are made if required and the final guidance is normally published on NICE's website within 15 working days. Consultees (including appellants) and commentators are informed of the date of publication, and are sent the Appeal Panel's decision and a copy of the final guidance 2 working days beforehand.

Appeal dismissed

If the appeal is dismissed and the Appeal Panel has not requested changes to the final draft guidance, the Guidance Executive will aim to consider the appeal decision within 10 working days of receipt of the appeal decision. After the Guidance Executive meeting, the final guidance is normally published on NICE's website within 15 working days. Consultees (including appellants) and commentators are informed of the date of publication, and are sent the Appeal Panel's decision and a copy of the final guidance 2 working days beforehand.

11.3 What happens after the appeal decision is published?

There is no possibility of further appeal against the decision of the Appeal Panel. However, this decision and NICE's decision to issue the final guidance may be challenged by applying to the High Court for permission to apply for a judicial review. Any such application must be made promptly and within 3 months of publishing the final guidance.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 28 2018, 03:58 AM


Group: Member
Posts: 482

The only thing that struck me was the mentioning of regulatory
approval of the cosmetic product. Cosmetics are not subject to EMA or FDA
regulation. There are guidelines especially when it comes to sun screen products regarding
the wording of the label etc. but that’s it. How come we need
regulatory approval ?
  Forum: By Share Code

FarmaZutical
Posted on: Jul 23 2018, 12:44 AM


Group: Member
Posts: 482

On a différent note and just because it’s Sunday and I have time to
speculate: I think Mr. Blijdorp will replace Stan as chair later this year.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 23 2018, 12:42 AM


Group: Member
Posts: 482

Seems like the wording is the problem. They are trying to patent
Afamelanotide as a drug, or inadvertently they are doing so because of poor wording
while actually trying to patent the use for the specific indication.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 21 2018, 01:34 PM


Group: Member
Posts: 482

This is an except from a blog post the CEO wrote in 2011.
I think it’s worth re-reading now when we’re approaching
crunch time for EPP in the US. EPP is only the beginning.

By PW:

From a corporate standpoint, Cerezyme is a prime example of why so many large pharmaceutical companies are now focusing specifically on the orphan drug space. Genzyme netted Cerezyme total sales in excess of US$1.5billion over the past two calendar years with estimates that around 5,000 Gaucher’s disease patients are taking the drug, 10% of them without charge. (Those sales included a period in 2010 where Cerezyme manufacture was disrupted, delivering the company lower than expected sales for the drug in 2010 (US$719m).) It’s undeniable that this is a sound business model but the risk lies in exploring an approval system which was primarily intended to incentivise companies to pay attention to rare disorders.
More enticing for many therapeutic developers of late, however, is the potential for their orphan drug technology to be used in broader medical applications; so called ‘translational medicine’. Here, drugs which have multiple potential applications are investigated for indications with the greatest clinical need first (often orphan indications, where there are still so few therapies for more than 6,000 rare and often severe diseases) before being tested for more common indications within the community. This affords a developer (but also the regulator) comfort that it has a level of safety and efficacy data. This staged approach safeguards regulatory acknowledgement before addressing broader applications (which, in turn, could lead to reductions in drug costs due to economies of scale). Here, a translational medicine born out of orphan drug status can not only help a broader patient community, but also provide even greater returns for those who have invested time and money in a high-risk industry. It really is a win-win situation. However, patience is required from investors; they need to understand the long-term view and processes involved.
It is likely that we will see more orphan drug R&D announcements in the future as pharmaceutical companies expand their presence in the space. Hopefully the goals here will remain true to the orphan drug legislation and we can continue to provide new and better therapies to those patients who need them the most.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 21 2018, 12:13 AM


Group: Member
Posts: 482

Wolgen said the company hopes to make a topical product for wider consumption; in his opinion, a pill or a drink would be unnecessary and dangerous due to the risk of an overdose. Additionally, it will be another six to 12 months before the FDA finishes reviewing Scenesse for limited use.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 17 2018, 08:42 PM


Group: Member
Posts: 482

I bet it suits PW very well that the SP is not rising right before the NICE appeal and possible FDA priority review.

“Ponimus crescente per fundas feneret ripa usque ridenti” doesn’t really fit the story of a little, humble, altruistic
company.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 11 2018, 04:24 AM


Group: Member
Posts: 482

Are you able to re-post ?
  Forum: By Share Code

FarmaZutical
Posted on: Jul 9 2018, 09:03 PM


Group: Member
Posts: 482

T’sumoyle and Chivére could be two different products with different MOA but both photoprotectants. The
French sounding product Chivére would be better suited for the Western markets and might
contain ingredients that in some way promote melanogenesis; although it seems very unlikely
since it’s a cosmetic. But Westeners want darker skin while many Asians mostly
prefere lighter skin. T’sumoyle with its apostrophe and slightly Chinese looking name
could be the product for the Asian region and have photoprotective properties while not
making the skin darker.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 8 2018, 10:11 PM


Group: Member
Posts: 482

I think it’s more and more likely that Willem Blijdorp and his company B&S International will be
instrumental in distributing Clinuvel’s new cosmetic line and that it will
probably be through tax free retailers in airports; mainly or partly in the Asia Pacific.

Cosmetic giants like Estée Lauder, L’Oréal, Unilever & Procter and Gamble are all very focused
on travel retail, according to this article: http://sc.mp/fJ7SDs

The market is huge and travel retail is exactly what B&S International are experts in.

The article mentions the TFWA international summit in Cannes and how the Tax Free Works Association gathers the
Global travel retail industry in France for this 5 days summit. I’d never heard about TFWA but
apparently Clinuvel attended the 2018 TFWA Asia Pacific conference in Singapore in May: http://clinuvel.com/2007-announcements/ite...gory/776-events

Scenesse isn’t exactly a product for the travel retail market so when Clinuvel attends this
conference it has to be with a different product and scope in mind. Chivere and t’Sumoyle seem
like products that could be a shoe in for this market.



  Forum: By Share Code

FarmaZutical
Posted on: Jul 7 2018, 07:17 PM


Group: Member
Posts: 482

I knew you would have a much better explanation. Thanks Frogster. It sounds very plausible. I wonder if Blijdorp is a candidate to replace Stan later this year.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 7 2018, 12:46 AM


Group: Member
Posts: 482

I’m sure Frogster and others are more qualified to answer this question
but I find it very unlikely that such a transaction is not pre arranged with
the parties having negotiated price and timing well in advance.
But again it’s not my field.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 6 2018, 03:05 PM


Group: Member
Posts: 482

So it was Blijdorp who acquired those 1,359,973 shares from Lagoda at $10.
Good for him. And very bullish.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 4 2018, 06:13 PM


Group: Member
Posts: 482

We don’t know how and when this was negotiated and with whom. It could be pre arranged long ago.
It could be a transfer of shares from a custodial account to a private one. It could be
Lagoda locking in profits to balance off some of their bad investments.
For comparison, Lagoda’s largest holding according to the 13F is Trupanion
at a current value of $23 m. 7 % of Clinuvel represents a current value of $26 m.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 2 2018, 06:36 PM


Group: Member
Posts: 482

I have no idea. But it would make sense to await registration of the trademark so I’d say we have to wait another month or two.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 2 2018, 06:23 PM


Group: Member
Posts: 482

Ok, August 17th then. Thanks.
  Forum: By Share Code

FarmaZutical
Posted on: Jul 2 2018, 04:30 PM


Group: Member
Posts: 482

The Chivére trademark has been approved.

https://trademarks.justia.com/792/17/chivere-79217953.html

  Forum: By Share Code

FarmaZutical
Posted on: Jun 23 2018, 04:07 PM


Group: Member
Posts: 482

Monday is World Vitiligo Day. Could that be related to the trading halt ?
During a normal procedure, submitting an NDA only involves the sponsor and the FDA.
No risk of leaks. Everything is confidential. Therefore, I think the trading halt could
be due to a 3rd party being involved somehow. Announcement on World Vitiligo Day would be a good stage.
Speculation on a Friday night.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 23 2018, 12:53 AM


Group: Member
Posts: 482

And it works :-) Thanks a lot !!
  Forum: By Share Code

FarmaZutical
Posted on: Jun 23 2018, 12:45 AM


Group: Member
Posts: 482

Unfortunately not here. Only getting a blank page. But thanks for the effort.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 23 2018, 12:30 AM


Group: Member
Posts: 482

Would you be able to post US level 2 here ? Thanks
  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2018, 04:25 PM


Group: Member
Posts: 482

8. Debt settlement
9. Is there room for my family in my mother’s appartment ?
10. How old do the kids need to be to legally work ?
  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2018, 01:09 PM


Group: Member
Posts: 482

We should expect a PR within 4 hours before Germany and later the US opens. Otherwise
a trading halt in Australia has no effect.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2018, 12:47 PM


Group: Member
Posts: 482

I have never seen a trading halt only due to an NDA being submitted. Ever.
It’s not uncommon to request a trading halt when the FDA has an advisory committee meeting,
but not at this stage.

  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2018, 06:24 AM


Group: Member
Posts: 482

Management want the stock to be unloved by the market. It’s obvious that they are actively
un-promoting the company through mumbo-jumbo pr’s, non existent IR and
a despise for retail investors. It’s the end game that counts and in the interim
they’d rather behave like a privately held company to not
drive up the share price too much which could provoke regulators and cause
more pushback. If you hang on as an unloved retail investor, in the end,
you will feel the love when the company is acquired or the revenues
so high that the market will have to react. Until then, PW and Lachlan Hay
will do what they can to keep a lid on expectations, the pps and anything
that could derail Scenesse. It could be done with much more professionalism and with respect for investors
but I do appreciate that there is a need to stay under the radar.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2018, 12:04 AM


Group: Member
Posts: 482

With US approval (most likely) coming up and subsequent reimbursement talks, it would be stupid to budge on the price in Britain. It would lower the fixed price for all countries.




  Forum: By Share Code

FarmaZutical
Posted on: Jun 22 2018, 12:00 AM


Group: Member
Posts: 482

Unfortunately not. From a quick glance it seems most of the appeals were finally rejected.


  Forum: By Share Code

FarmaZutical
Posted on: Jun 21 2018, 11:19 PM


Group: Member
Posts: 482

https://www.nice.org.uk/about/what-we-do/ou...s-and-decisions

If they don’t win this one the next stop will be high court.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 21 2018, 03:37 AM


Group: Member
Posts: 482

If Clinuvel doesn't file the last module of the NDA by July 1st it will be the last and final evidence, that a Clinuvel deadline can never again be taken seriously. Lachlan Hay and Dr. Wolgen really need to deliver on this one.


  Forum: By Share Code

FarmaZutical
Posted on: Jun 16 2018, 12:38 AM


Group: Member
Posts: 482

I suggest a sweepstake.

Whoever thinks Clinuvel will meet the deadline replies
with a YES.

Whoever thinks they won’t file by July 1st replies with a NO.

The winners will be able to brag about it.
The looses commit to donating $100 to the young
EPP sufferer’s Gofundme.

  Forum: By Share Code

FarmaZutical
Posted on: Jun 15 2018, 08:20 PM


Group: Member
Posts: 482

I concur. It should be fairly easy to forecast only a few weeks ahead.
But to answer your question, where should a new delay come from ?
Management !

I hope I’m proven wrong and that the NDA is filed one of these days.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 15 2018, 06:41 PM


Group: Member
Posts: 482

I think there is 0 % chance that Clinuvel will file the NDA by July 1st.
My expectation is sometime in Q3. Do you remember the quote by Lachlan Hay: “Surely by year’s end.” That was years end
2017 and he said it early 2017.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 14 2018, 12:33 AM


Group: Member
Posts: 482

Bad news is an option. But I think stop-losses being triggered by one or two initial retail sales are the reason. It doesn't take much to start and avalanche with such a thinly traded stock. Homm's pumping has brought in a lot of new investors with only one scope: fast money. Many of them probably don't have the same vision as many on this board and they will have stop-loss orders in place. I don't.




EDIT: The sell off started on the ASX on relatively limited volume but the avalanche spread to Germany (Homm land) and then the US.






  Forum: By Share Code

FarmaZutical
Posted on: Jun 13 2018, 03:39 PM


Group: Member
Posts: 482

Relatively low volume sell off. Gap closing.
Time to go above $14 on next leg up.
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  Forum: By Share Code

FarmaZutical
Posted on: Jun 7 2018, 01:44 AM


Group: Member
Posts: 482

Hey JT,

The Priority Review that Clinuvel may get is not the same as the Priority Review Voucher Program. If we get priority review for Scenesse, it's not a voucher and it can't be sold.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 3 2018, 04:17 PM


Group: Member
Posts: 482

So, Giles Delaney is supposed to be an experienced business journalist.
He has no Twitter account, I have found 0 bylines with his name having spent
a considerable amount of time searching and no Facebook either.

I found an Anne Giles Delaney who is a sports reporter in Florida, but no
business journalist with the name Giles Delaney.

A journalist without a social media presence? Very unlikely.
And why are there no pieces by him to be found anywhere
on the Internet ?

There are many journalists with the name Delaney but no Giles.
Giles Delaney could of course be a pseudonym.

Giles could also be a middle name that he hasn’t used in his
bylines as a journalist, e.g. James G. Delaney or Kevin G. Delaney
but the only business journalists named Delaney I can find don’t
seem like the types that would be for hire by Clinuvel: Arthur Delaney of
Huff Post and Kevin Delaney who founded Quartz.

I don’t think Giles Delaney exists.
  Forum: By Share Code

FarmaZutical
Posted on: Jun 2 2018, 03:39 AM


Group: Member
Posts: 482

BPA is participating in the appeal in Britain. They published this questionaire online to be used in the appeal. I don't see how it could be of any use, though.

https://www.surveymonkey.co.uk/r/Z8CX5WD

https://www.facebook.com/groups/110926852272162//




  Forum: By Share Code

FarmaZutical
Posted on: May 30 2018, 05:22 PM


Group: Member
Posts: 482

I think we are missing the whole point. Clearly, the company wants to stand out from the crowd of streamlined biopharmaceuticals. They are doing so by having the weirdest logo ever. The website is crammed with pseudo scientific and academic information. The blog is something I have never seen elsewhere. They spend a lot of time writing about how to be ethical and less about the wonders of their products. Other companies have streamlined websites with to the point information and flashy catchphrases. I think this company is doing everything to look a little amateurish and with softer edges. It’s not about profits. It’s about patients and the mission. I hope I’m right and that there is actually a thought behind it all. I think there is
  Forum: By Share Code

FarmaZutical
Posted on: May 30 2018, 03:32 AM


Group: Member
Posts: 482

The blog is an odd attempt to appear open to outside "journalistic" scrutiny, although Delaney doesn't write anything that directly relates to Clinuvel and to an even lesser extent anyting that is critical towards the Company.

Also, it's probably an attempt by Clinuvel to seem reflective - by proxy.

I find his blogs harmles and a bit boring. Perhaps if he wrote in Latin, it would spice it up.
  Forum: By Share Code

FarmaZutical
Posted on: May 29 2018, 04:29 PM


Group: Member
Posts: 482

What's in a name? That which we call a rose by any other name would smell as sweet.
We are such stuff as dreams are made on, and our little life is rounded with a sleep.
Fair is foul, and foul is fair: Hover through the fog and filthy air.

Best, Stan
  Forum: By Share Code

FarmaZutical
Posted on: May 29 2018, 03:34 AM


Group: Member
Posts: 482

I almost had a heart attack 😀
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FarmaZutical
Posted on: May 28 2018, 08:37 PM


Group: Member
Posts: 482

The FDA has been reviewing the 4 modules and provided guidance to Clinuvel for quite some time now.
The formal review of the complete NDA hasn’t begun yet and the clock hasn’t started.
But it’s not inaccurate to write that the FDA is reviewing Scenesse.
  Forum: By Share Code

FarmaZutical
Posted on: May 27 2018, 05:42 AM


Group: Member
Posts: 482

Yes.

This explains the US reimbursement system well:

https://www.slideshare.net/knehaslide/pharm...imbursement-usa
  Forum: By Share Code

FarmaZutical
Posted on: May 25 2018, 11:48 PM


Group: Member
Posts: 482

It's not true. The guy is just trolling. Don't waste your time.


FACTS:

The clinical trials CUV015, CUV016, CUV023 & CUV017 took place in Britain or was partly carried
out in Britain.

Britain has never been part of an early access scheme as Italy and Switzerland.

Britan has never payed the reduced price for the implant.

No one knows what Britain would be prepared to pay if they have any money left.

The British CHMP member Greg Markey voted against approval of Afamelanotide in 2014.
  Forum: By Share Code

FarmaZutical
Posted on: May 25 2018, 06:51 AM


Group: Member
Posts: 482

This speaks for itself:

https://www.facebook.com/AccelerateApproval...593692664014095
  Forum: By Share Code

FarmaZutical
Posted on: May 23 2018, 04:46 AM


Group: Member
Posts: 482

But Clinuvel won't budge on the price:

Following consultation, the British Association of Dermatologists queried the possibility of developing a managed access agreement (MAA) to address the uncertainties. The committee noted that it could consider an MAA proposal if all stakeholders collaborated to develop and support it. The committee noted that it had not been presented with a proposal but discussed whether a proposal could potentially address the 2 main elements of an MAA: (...)



Sharing of financial risk during the MAA: the committee noted that an MAA would typically include financial components that would apply while it is in force to share the financial risk with the NHS. The company stated that it offered a single price across countries and there was no scope for this to differ in England. However, it was willing to enter into discussions with NHS England to cap financial risk to the NHS. The committee considered this in the context of the cost-effectiveness estimates discussed in section 4.20. The committee was aware that these estimates (ranging between £1,343,359 and £1,785,957 per QALY gained) were very much above what could be considered an acceptable use of NHS resources, making it highly unlikely that afamelanotide has a plausible potential to be considered cost effective.
  Forum: By Share Code

FarmaZutical
Posted on: May 23 2018, 04:23 AM


Group: Member
Posts: 482

Suggestion from the British Association of Dermatologists:

If the funding cannot be made available in the ‘classical’ way, we request that consideration should be given to creating a ‘managed access scheme’ or similar. People with EPP could be treated during an agreed assessment period (e.g. at least 2 consecutive years) for further data collection. This could potentially be done in specialised centres in Manchester (Salford Royal) and London (Guy’s & St Thomas’) which would also aim to help people with EPP alter their behaviour – “unlearning” a lifetime of avoiding the outdoors due to the severe pain endured), one of the factors that has probably contributed to the mismatch between the trial data and the patient testimony.




  Forum: By Share Code

FarmaZutical
Posted on: May 23 2018, 03:31 AM


Group: Member
Posts: 482

As expected. I don't think an appeal will change anything.

Clinuvel had great difficulties figuring out how to address NICE's

demand for QALY. They tried with DALY but that didn't fly either.

That gave NICE a reason to deny Scenesse although they

recognize it's effectiveness. Bottom line is that the British

EPP patients are fcuk'ed.


  Forum: By Share Code

FarmaZutical
Posted on: May 19 2018, 12:53 AM


Group: Member
Posts: 482

Unfortunately, I think NICE rejected Scenesse in the final evaluation determination and that Clinuvel

appealed. It fits the timeframe.


  Forum: By Share Code

FarmaZutical
Posted on: May 16 2018, 02:29 PM


Group: Member
Posts: 482

Discover Six Leading Luxury Skincare Brands From Asia
Tarandip Kaur, CONTRIBUTOR
Jul 27, 20173:04 AM21,738
A couple of years ago, most would often turn to the West when searching for the next up-and-coming product in the world of beauty. Now all eyes are on Asia and its remarkable growth. According to a report from Euromonitor International, sales from the region’s beauty market is estimated to exceed $150 billion this year, and these brands are expected to account for 80% of global cosmetics revenue gain by 2019.

With that much potential revenue on the line, here are six of the leading Asian beauty brands who deserve your attention in this burgeoning industry.



Sulwhasoo – Korea


Sulwhasoo
Restore your skin’s balance by utilizing the First Care [+]
About 50 years ago, the founder of Amorepacific – the parent company of Sulwhasoo – Suh Sung-whan had this question: “If ginseng is good for the body when eaten, wouldn’t it have an equally positive effect on the skin?” From that came the signature product - the ABC Ginseng Cream in 1966 – which not only became the world’s first ginseng-based cosmetic but also built the foundations for the Sulwhasoo brand.



Ultimately, the brand grew to incorporate Asian medicinal herbs, time-tested traditional Korean herbal medicine and advanced skin science to create a luxurious product line that now boasts a major following amongst celebrities and consumers.

In 2016, Sulwhasoo displayed nearly 40 percent year-on-year revenue growth reflecting its popularity in the Greater China and ASEAN region. Currently, the skin care giant has their hearts set on ramping up global expansion efforts to solidify their position as one of the top skin care brands in Asia and become one of the top 7 globally.



One of their best selling products is the First Care Activating Serum EX (approx. $92). Formulated with JAUM Balancing Complex™ – a blend of medicinal herbs like peony, sacred lotus, Solomon’s seal, white lily, and Rehmannia – this serum is used as the first step in your skincare routine to enhance skin radiance and protect against signs of aging.

Shiseido – Japan


Shiseido
Infused with rose and lotus scents, the Shiseido Ultimune [+]
With origins as a pharmaceuticals company back in 1872, Shiseido has since transformed to become a full-fledged cosmetics brand that was ranked 9th globally in 2016, based on data from Euromonitor International.

By banking on its Asian heritage and concocting unique formulas made from natural flowers, the Japanese brand has consistently maintained its premium quality and gained a greater consumer base over the years. Through innovation and in-depth R&D, their formulas have been celebrated to no end. One example is their first anti-ageing skin care line, Benefiance in 1982, which has a relaxing fragrance cultivated with new aromachology.



Currently, winning over 114 beauty awards internationally, their Ultimate Power Infusing Concentrate (approx. $97) is a favourite amongst customers. It aids in defending the skin against signs of aging with its powerful blend of Bulgarian rose water, yeast extract, and gingko biloba leaf extract.

Su Man – Taiwan


Su Man Skincare
Su Man always recommends carrying the Facial Glow [+]
From Taiwan, the celebrity facialist, Su Man, boasts a luxurious salon in London with frequent guests that include Juliette Binoche, Anne Hathaway, and Frieda Pinto. Known for her use of the unique Shiatsu-inspired approach, a massage technique that repeats each stroke 36 times, clients are always left impressed with her services.

However, when she couldn’t get the results she wanted from using other products during her facials, she dived head first into developing an eponymous skincare line. Through the use of natural essences from original homemade recipes, Su Man worked with French and Taiwanese chemists to perfect her formulations and included active ingredients such as rosehip seed oil, rice silk, green tea and dragon’s blood – a sap extracted from the Sangre de Drago tree native to the Amazon rainforest.




For Su Man, one of their most sought after products is the Facial Glow Rejuvenating Mask (approx. $55). Infused with a rich blend of skin-nourishing ingredients, the bio cellulose mask wraps the face and replicates the effects of a 10-minute facial treatment.

More on Forbes: Meet The Woman Behind Two Of Asia’s Ultra-Luxury E-Commerce Platforms

SK-II – Japan


SK-II
If there’s one staple you need from SK-II, let it be this [+]
As the story goes, SK-II was born in the 1970s when scientists chanced upon a Japanese sake brewery. There they noticed the elderly workers had really soft and smooth hands despite being in constant contact with the yeast fermentation process. Soon, they discovered there was a type of yeast rich in skin-beneficial nutrients, called pitera, which went on to form the very foundation of SK-II.



With the SK standing for ‘Secret Key’, ultimately the indulgent skin care line did become a special secret shared between women and celebrities. Some of which include Cate Blanchett, Kate Bosworth, Sheila Sim from Singapore and QiQi from China.

Now owned by Procter and Gamble, SK-II carries a whole range of innovative products that combine years of scientific testing and experimentation, which earned it the top spot among P&G’s Billion-Dollar Brands in 2011.

Containing 90% Pitera, the SK-II Facial Treatment Essence (approx. $189) forms the core essence of the brand. Its popularity is so great that it has seen more than 20 million bottles sold to date – a bottle is typically sold every 22 seconds.

SU:M37° – Korea


SU:M37
Encased in sleek, minimalist packaging, SU:M37° products [+]


Owned and managed by Korean giant LG Household and Healthcare (LG H&H), SU:M37° is best known for its fermented skin care line. Essentially over 80 ingredients are fermented in the optimal 37° Celsius temperature for 365 days, and some for as long as a decade. This lengthy process results in richer and finer essences that help to enhance the skin’s natural healing process over time.

Considered as one of LG’s more successful brands, SU:M37° saw their net sales grow to 343 billion won ($307 million) in 2016, according to LG H&H – despite the brand only being around since 2007. They’ve quickly gained a loyal following and found their place amongst other premium skin care brands from the region.


Though many of their products have been successful, one that’s typically mentioned is the Secret Essence (approx. $79). It promises to help rebuild and strengthen the skin against external stressors while improving the skin’s natural tone, firmness, texture and hydration levels with its antioxidant-rich formula.

Albion – Japan

Albion
In 2016, 4.1 million bottles of the Skin Conditioner were [+]


Established in 1956, right after World War II, Albion – which means ‘white land’ in Japanese – aimed to be a luxury beauty brand at a time when ‘luxury’ was not yet a concept.

From being the first to develop emulsion technology to produce the first oil-in-water hydrophilic milk to using squalene in its formulations back when it was a pricey ingredient, the Japanese company quickly scaled the ranks to become one of the preferred brands by discerning customers.

Now available in Singapore, Hong Kong, Taiwan, China and Malaysia, Albion has achieved a strong double digit growth that is close to 50% in 2016. It’s no doubt the products speak for themselves with proven efficacy.

Take for instance their signature product, the Albion Skin Conditioner (approx. $102), which has seen millions of bottles sold since its launch in 1974. Formulated with Job’s Tears – a medicinal herb used in ancient times – the Skin Conditioner is known for boosting skin metabolism and regulating cell renewal to promote radiance, clarify the skin, and refine skin texture.

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  Forum: By Share Code

FarmaZutical
Posted on: May 16 2018, 02:20 PM


Group: Member
Posts: 482

Common Asian Skin Conditions and Treatments

November 22, 2015
Common Asian Skin Conditions and Treatments Image
Asian skin conditions have genetic influences from a range of countries that include China, Japan, India, Southern Asia and part of the Pacific. Skin tones vary from very pale skin to light or dark brown. Regardless of climate variables that affect skin health, some skin conditions seem to be more prevalent among Asian people.
“My goal is to provide personalized, comprehensive medical and surgical dermatology for people of all ages and ethnicities here in our new Central Texas home.”
- Weilan Johnson, MD, Dermatology Associates of Central Texas

Acne

Asian skin produces more oil due to the warmer climates of the regions. As a result Asians are more vulnerable than others to acne outbreaks. In most cases the breakouts are keloids, hardened bumps. Unfortunately, without treatment, this can lead to acne scarring.

Melanin is abundant in Asian skin and melanin cells are sensitive to inflammation or injury. When Asian skin is affected with deeper acne pustules it can leave post-inflammatory hyperpigmentation (PIH). These are dark spots or patches that stay on the skin after a skin injury. Almost any kind of rash or acne can make this happen.

Medications to clear acne include some OTC products. These acne products help reduce the incidence of PIH. Another product that is very effective in protecting Asian skin from uneven skin tone is sunscreen.

Keep sun exposure to a minimum, wear sun-protective clothes and hats with a brim, as well as use a broad spectrum SPF 30 or 50 sunscreen.

Removing the surface skin cells or exfoliation improves both acne and hyperpigmentation. With acne managed, treating pigmentation problems is easier. Chemical peels and cosmeceuticals can be helpful with that. Remember, these are procedures that should be performed only by a board-certified dermatologist.

Hyperpigmentation and Hypopigmentation

Asians do not wrinkle like Caucasians and Africans because they have higher levels of natural hydration. Their primary age-related skin problems are dark spots. These spots are due to hyperpigmentation—an imbalance of skin tone highly visible against the contrast of warm, smooth Asian skin.

Another skin disorder that South Asians worry with is melasma. It shows up as brownish spots on the face. Asians experience it sometimes in pregnancy, but other people with darker skin also experience it. Too much sun and irritations to the skin can make it worse.

Common Hypopigmentation Skin Disorders

Vitiligo occurs among all ethnicities, but is common in South Asians. The contrast of light patches on darker skin makes it more noticeable. With vitiligo your immune system disrupts skin pigment cells. This creates white patches on the skin and mucous membranes. Vitiligo can exist alone, but can also be associated with other immune system medical conditions.
  Forum: By Share Code

FarmaZutical
Posted on: May 6 2018, 02:51 PM


Group: Member
Posts: 482

Dr Wolgen, March, 2018:

“The complementary use of non-prescriptive products is aimed to fit the strategic direction of CLINUVEL and increase brand awareness of the Company.”

February, 2018:

“We have established ourselves as the leaders and experts in an emerging field of photomedicine and now seek to expand our research delivering lifelong care and novel products for patients and users. Our first product SCENESSE® offers an innovative solution to EPP patients in a specialised setting, and now we are close to launching the first of our complimentary Skin & Body Care products to strengthen our offering.,” Dr Wolgen said.”



(Sorry for the previous double post)
  Forum: By Share Code

FarmaZutical
Posted on: May 6 2018, 02:26 PM


Group: Member
Posts: 482

Dr Wolgen, July, 2017:

“Once the final of the five modules are submitted, and the FDA has validated the dossier, our teams will announce the start of the FDA’s review clock.”

The NDA could be submitted by now.
  Forum: By Share Code

FarmaZutical
Posted on: May 6 2018, 02:26 PM


Group: Member
Posts: 482

Dr Wolgen, July, 2017:

“Once the final of the five modules are submitted, and the FDA has validated the dossier, our teams will announce the start of the FDA’s review clock.”

The NDA could be submitted by now.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 29 2018, 10:32 PM


Group: Member
Posts: 482

Sum oil / sun oil ?
  Forum: By Share Code

FarmaZutical
Posted on: Apr 29 2018, 08:06 PM


Group: Member
Posts: 482

I know I somewhat keep repeating myself, but T’sumoil and / or Chivere
are puzzling me. Clinuvel registred a Facebook page for
Tsumoil so it seems this product is part of the imminent launch.

From the trademark application we know that it’s based on afamelanotide.
It’s a skin care lotion. It seems to be launched soon. We don’t know where and by whom.
And we don’t know how they managed to get this cosmeceutical through
the scrutiny of the regulators.

If all this is correct, it could be extremely valuable.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 25 2018, 12:14 AM


Group: Member
Posts: 482

Interesting that they don’t mention #EPP but use #dermatology and other hashtags.
It seems they are gearing up to the launch of the skin care line.
I’m still very curious if the lotion(s) will contain a-msh.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 21 2018, 08:05 AM


Group: Member
Posts: 482

Thanks a lot. I was worried it was another Lachlan classic.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 21 2018, 04:46 AM


Group: Member
Posts: 482

Apparently, Clinuvel did not pay the trademark fee for Scenesse and it has now
been cancelled. Very professional.

You must file a Section 71 declaration, specimen, and fee on a date that falls on or between the fifth (5th) and sixth (6th)-year anniversaries of the date on which the USPTO issued the certificate of extension of protection (or, for an extra fee of $100.00 per class, you may file within the six-month grace period following the sixth (6th)-year anniversary date). You must subsequently file a Section 71 declaration, specimen, and fee on a date that falls on or between the ninth (9th) and tenth (10th)-year anniversaries of the date on which the USPTO issued the certificate of extension of protection, and each successive ten-year period thereafter (or, for an extra fee of $100.00 per class, you may file within the six-month grace period following each ten-year period). Failure to file the required Section 71 will result in cancellation of the registration and invalidation of the extension of the international registration to the United States.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 21 2018, 04:28 AM


Group: Member
Posts: 482

Does anyone know what this means ?

https://trademarks.justia.com/790/88/scenesse-79088813.html


Cancelled ?!?
  Forum: By Share Code

FarmaZutical
Posted on: Apr 14 2018, 02:20 PM


Group: Member
Posts: 482

In theory, yes. There are examples of NDA approvals that are expedited
beyond the normal time frames. But rolling review does not mean that the FDA
commences the formal review until the dossier is complete and submitted.
It’s merely a matter of continuous communication between the sponsor and the
FDA’s teams and the sponsor will know when the FDA deems the modules
ready and approvalble. The term rolling review is in some ways misleading since it’s not
a formal review but merely guidance prior to the real review. That said, some drugs have been approved
super fast but I doubt we will be in that category.

In our case, rolling review is an insurance policy that the FDA
and Clinuvel have a mutual understanding of the modules
being ready for formal scrutiny.

Therefore, my bet is that Clinuvel will submit the final module within
a few weeks or months. Hopefully weeks. And that the FDA will
validate the dossier and grant priority review based on our fast track
designation. That will result in a 6 months review period if we don’t encounter
any road blocks. I have a feeling now that PDUFA will be Q1 2019.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 11 2018, 05:17 PM


Group: Member
Posts: 482

Unfortunately, this seems to be yet another example of
poor and inaccurate communication. Although you can argue
that, technically, the FDA is “reviewing” Scenesse and has been doing so
for several years now, they are not reviewing the NDA since it
hasn’t been submitted.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 9 2018, 03:37 PM


Group: Member
Posts: 482

I don’t believe they are hiding anything. They are just very inaccurate and amateurish
when it comes to communicating. We never really know what they mean so we try to
interpret and translate their their words. Right now they are trying to prepare
a dossier of the highest possible standard with the highest probability of being
accepted. It takes time and they got our hopes up it would be right
after the expert meeting which it wasn’t. Again, poor communication.
PW wants Scenesse approved just as much as we do.
Hang in!
  Forum: By Share Code

FarmaZutical
Posted on: Apr 4 2018, 06:34 PM


Group: Member
Posts: 482

It still puzzles me what PW has up his sleeve with regard to
the new cosmetic product line. It can’t be afamelanotide since it’s
not OTC. Could it be a bioidentical a-msh in the form of a lotion ?
That wouldn’t penetrate the skin so that seems unlikely, too.
But why would Clinuvel venture into skin ointments if they
don’t provide photo protection ? This is their core business.
An advanced SPF 10.000 ? I fear we’ll be disappointed come May 20th
but I hope PW delivers a miracle.
  Forum: By Share Code

FarmaZutical
Posted on: Apr 2 2018, 04:11 AM


Group: Member
Posts: 482

Clinuvel already has ODD for these indications. They described the
new indication and a “new” orphan indication so I’m assuming
the pilot will indeed be for a new indication.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 30 2018, 08:19 PM


Group: Member
Posts: 482

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.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 28 2018, 03:15 PM


Group: Member
Posts: 482

In the previous news letter they wrote that data analysis was ongoing so
not unexpected that the NDA hasn’t been filed. I’m satisfied with
the recent communiqués and would rather see a bulletproof NDA
than a rushed one. Also, I’m not at all sure Brem will be approved before
Scenesse just because they filed the NDA before us. I’m not sure Brem
will be approved at all.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 28 2018, 01:59 AM


Group: Member
Posts: 482

Early access is definitely not on the table. Early access is only for life threatening conditions and
is in many ways a burden to the sponsor. You can’t charge full price, only what’s considered
reasonable in order to administer the drug. Allowing early access puts the sponsor in a weaker
position once they are to negotiate real reimbursement. And EAP - Early Access Program - is usually only for select patients. Clinuvel would not benefit
from a last minute compassionate use scheme.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 24 2018, 07:45 PM


Group: Member
Posts: 482

Forsitan Lachlanus in vacation paschae
  Forum: By Share Code

FarmaZutical
Posted on: Mar 24 2018, 04:19 PM


Group: Member
Posts: 482

Quare facta est turba non denuntiationem de isto?
  Forum: By Share Code

FarmaZutical
Posted on: Mar 21 2018, 07:15 AM


Group: Member
Posts: 482

British Association of Dermatologists responds to
the NICE refusal. Makes case that Scenesse should be
reimbursed.

http://www.bad.org.uk/shared/get-file.ashx...emtype=document
  Forum: By Share Code

FarmaZutical
Posted on: Mar 16 2018, 06:28 PM


Group: Member
Posts: 482

In the minutes, yes. But since the report was given orally in a meeting
with public access the only right thing to do is for Clinuvel to
issue a PR now.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 16 2018, 04:51 PM


Group: Member
Posts: 482

Decision reached in Wales:

“The Chair confirmed that an independent review panel (IR) had been convened on 23rd January to explore concerns expressed by the marketing authorisation holder in relation to AWMSG’s appraisal of afamelanotide (Scenesse®). The Chair confirmed he would report the outcome of the IR at the next AWMSG meeting.”

This quote is from the February meeting minutes. So on March 14th the chair reported the
outcome of the IR. This part of the meeting seems to be public, yet Clinuvel hasn’t sent out
a PR relaying the outcome.

http://www.awmsg.org/meetingszip/AWMSG%20m...ng%20papers.pdf
  Forum: By Share Code

FarmaZutical
Posted on: Mar 13 2018, 12:29 AM


Group: Member
Posts: 482

I agree. It seems very unlikely they can bring
any derivative of afamelanotide to market without
regulatory approval. Perhaps we’re blinded by the
Chivere trademark application and the new products
are not related.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 12 2018, 11:30 PM


Group: Member
Posts: 482

But the interesting part remains that it’s all based
on an afamelanotide derivative. If the new products are indeed
Chivere it’s likely to be a mélanocyte stimulating lotion.
The question is if Chivere is a trademark to be used
for CUV9900 down the road or if it’s a part of the imminent
product launch.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 12 2018, 08:03 PM


Group: Member
Posts: 482

As I understand it Clinuvel used parantheses in the
application which is not allowed. The Australian trademark protection
is now live. I assume the others will follow.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 12 2018, 06:46 AM


Group: Member
Posts: 482

I wonder why they will annonce the new product line on a Sunday.
Is it due to a time difference ? It’s Monday morning in Singapore and Australia while it’s still
Sunday in Europe and the US. Btw, the Chivere trademark was recently
approved in Australia.
  Forum: By Share Code

FarmaZutical
Posted on: Mar 10 2018, 10:02 PM


Group: Member
Posts: 482

From FB

Heute mal was auf Englisch...

The following story is not NICE but really NASTY;-)

Dear National Institute for Health and Care Excellence UK (NICE),

deciding not to recommend a life changing medication for people suffering from EPP would not be nice but nasty. I am suffering from EPP myself. A few years ago I had the chance to try the new medication called Scenesse (Afamelanotide) myself during a clinical trial. Before this I really suffered from EPP. I could not spend my daily life outside like other people. Even normal activities like picking up my kid from school, spending some time at a playground, in our garden or simply doing the groceries always have been a challenge as soon as there was too much light involved. Extra activities, like bicycle tours, open swimming pools and holidays were impossible for me. Light was my enemy and pain was my unpleasant companion.

When I started to take Scenesse medication it changed my life. I was able to do all these normal things with my kid. Walking on the sunny side of the road and the sunny side of life! It was increadible for me! I was even able to drive two hours per day in my car to attend a study course. This great time with a nearly normal life ended after the trial was finished. The EPP pain is back and I am suffering again. Now I have tw kids, one of them severely disabled. And the new challange is to cope with EPP having a kid that won't understand why mommy can't go outside.

I am now waiting to get treated with Scenesse again. Want to get back to the sunny side of life on the sunny side of the road! Here in Germany I have a realistic chance that this will become reality.

However, people in the UK won't have the chance if NICE refuses to recommend Scenesse as a treatment for EPP patients in the UK.

PLEASE SHARE and support the British EPP Patients!
http://www.porphyria.org.uk/?page_id=2619
  Forum: By Share Code

FarmaZutical
Posted on: Mar 10 2018, 10:01 PM


Group: Member
Posts: 482

Double post












































































..
  Forum: By Share Code

FarmaZutical
Posted on: Mar 1 2018, 05:30 PM


Group: Member
Posts: 482

Puto quod logo logo est enim coetus atque maybe nos videre creatio autem novam societatem. Contingit enim hoc esse futurum Dianae Integer nova societate conservet laxamenti Integer veteris Clinuvel animalia. De turba coepit et ad se in coetus, ut faciam sensus.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 21 2018, 11:34 PM


Group: Member
Posts: 482

Again, we’re missing the point.

It’s the latex suit that delivers the sun protection.


Attached thumbnail(s)
Attached Image



 
  Forum: By Share Code

FarmaZutical
Posted on: Feb 21 2018, 12:58 AM


Group: Member
Posts: 482

This is from the new website and i caught my eye:




QUOTE
From pharmaceutical to a broader user base benefiting from scientific advancements benefiting clinical care and medicine. CLINUVEL believes there is much value one can derive from physicians' and patients' experiences benefiting eventually a wider user base downstream. In other words, our non-pharmaceutical products are derived from processes, knowledge and technological advancement made and discovered during clinical care.


CLINUVEL's teams pride themselves to apply the learnings from clinical care to favour products for everyday use, furthering innovation to solve complex problems for healthcare and skin care.

As can be seen in the flow diagram of CLINUVEL's MODEL, we seek to introduce technology by ensuring that the immediate environment is ready for acceptance too. Innovation of technology and finding solutions is not sufficient to guarantee success, we also need to make sure the immediate environment, decision makers, policy makers, users receive ample information on our intended changes to existing products. In the immediate future we will launch a product line for comprehensive skin care which will serve us under extreme conditions



So the new skin care products are related to Clinuvel's R/D in melanocortins ?



  Forum: By Share Code

FarmaZutical
Posted on: Feb 21 2018, 12:56 AM


Group: Member
Posts: 482

I think we might be missing the point, here. Clinuvel wants to distinguish the company from other pharma companies at a time where high drug prices and questionable ethics are front page material.

They achieved just that with a non-flashy logo (extremely ugly and difficult to decode). I think it's deliberate. Other Companies are in the hot seat for raising prices and Clinuvel wants to show regulators that they are different. It's not about making money (even though the company has every right to do so - we're not a charity) it's about serving the people; hence the latin tag line.

Clinuvel is under attack from all the ignorant regulators who for decades have tried to stop a wonderdrug from reaching the market becuase they are afraid of the tanning effect. We all know why this approach is reactionary and hindering many patients in living better lives. But from the EMA over the German and Swiss insurance companies to NICE we have seen how they blatantly try to kill Clinuvel and I think Clinuvel decided that if you can't beat them, you must please them.

This whole new value, logo & website farce is not aimed at new investors. That is fairly obvious. It's way too ugly and messy to serve that purpose. It's aimed at regulators.

I don't blame Clinuvel for taking this approach. They have been treated so unfairly by all the regulators so they need to try something different. Some day when all this is behind us, we might get a real website and a nice logo.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 16 2018, 08:14 PM


Group: Member
Posts: 482

... and when you read the AGM presentation it’s pretty
obvious that the new products won’t contain msh. The CUV 9900
PK studies a well into 2019 and 2020.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 16 2018, 06:35 PM


Group: Member
Posts: 482

If it weren’t for the Chivére trademark applications I would say
that in no way can they market an a-msh product without regulatory
approval and prior testing. But the Chivère application reads:

“Goods and Services
Skin care preparations; cosmetic preparations for skin care; cosmetic preparations for skin care, based on analogues of melanocyte stimulating hormone (MSH), in particular afamelanotide;”

So either the complementary products have no relation to Chivére or they
are in some way based on afamelanotide.

I, too, have been wondering about the launch date. FDA is the single biggest
goal in the history of Clinuvel and they blew it once because they went after the... cosmetic market.
Why jeopardize US appeoval now by launching an unregulated cosmetic afamelanotide lotion ?
  Forum: By Share Code

FarmaZutical
Posted on: Feb 14 2018, 02:38 AM


Group: Member
Posts: 482

Under normal circumstances, yes. But It seems odd that Dr. Wolgen
wouldn’t just state it like that in the communique. He writes that Clinuvel is
pooling the European data in order to submit the final module so, no, it
doesn’t sound like the NDA is filed yet.

I think they have a very close relationship with the FDA (RPM?), though.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 14 2018, 02:17 AM


Group: Member
Posts: 482

Under normal circumstances, the FDA assigns the RPM - regulatory project manager - before the review team is
assembled. And the RPM is assigned when the sponsor files the NDA. The team is assembled two weeks into
the validation process and then all sorts of determinations are
made by the team before eventually validating the NDA. Priority review
is one of them. So when Wolgen writes about FDA assigning reviewers to each module it sounds as if
the are well into the process. In any case, Clinuvel is in close contact with the FDA (RPM) and
they seem very confident about a positive review.

It’s a little peculiar that Dr. Wolgen says that the FDA reviewers are to
be recruited amongst “senior staff.” Usually, the reviewers aren’t senior staffers.
Decisions are made by FDA senior staff based on the reviewers work.

I liked the update. Good info. Dates.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 2 2018, 07:59 AM


Group: Member
Posts: 482

Evidently, there is risk. Otherwise biotech investing would
be an ATM. But I have no fear at all that Scenesse won’t be approved by the FDA.
That’s why I’m still here. If you think a CRL is more likely than
approval it’s silly to put your money in the company.
  Forum: By Share Code

FarmaZutical
Posted on: Feb 2 2018, 01:59 AM


Group: Member
Posts: 482

It's a Clinuvel classic: A statement in the form of a riddle.




The way the statement is worded, it makes sense the assume that Wolgen will resign in Q4 2020. Why would they even mention a date if it wasn't relevant ? Thay also write that Wolgen will be preparing Clinuvel for a "hand over." What does that imply ? Are we preparing for a take over in 3 years or will he simply pass on the baton to a new CEO ? Let the guessing begin.

And there is no coherence between the dates. The chair will step down somewhere in 2019 but most likely in H1 since 2018 will be his last "full year." That leaves us with at least a 18 months period where Clinuvel will have a new chair until Wolgen's contract expires in December 2020. Could Wolgen himself take the position as chair and remain as CEO ? Will they recruit a new chair ? Are they in talks with a partner WHO will put one of their own on the board as chair and prepare for Wolgen's exit and a buyout ?

All in all it's poor communication when it raises more questions than answers.

I think the chair was overly happy that he just inked a new contract with the CEO, whom he sees as crucial for the company's survival right now. He put it in his statement to share the joy without reflecting about what message he was conveying. And if the head of media proofread the statement and gave his advice he did a very poor job.

Perhaps Wolgen is not planning to leave at all. In 2020 a new chair can extend his contract with 3 more years and all our speculations were for nothing.

To flog a dead horse: Clinuvel needs a media person who knows what strategic communication means. A person who can put Clinuvel on the radar in a clever and controlled way without pumping in any way. A person who writes (and proofreads) in a clear, to the point and easily understandble langauge.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 31 2018, 08:09 PM


Group: Member
Posts: 482

GG is back
  Forum: By Share Code

FarmaZutical
Posted on: Jan 31 2018, 12:13 AM


Group: Member
Posts: 482

There is a huge difference between IR and PR.


  Forum: By Share Code

FarmaZutical
Posted on: Jan 30 2018, 11:58 PM


Group: Member
Posts: 482

When the head of media, Lachlan Hay, erases his last name from his (already very thin) LinkedIn profile it's obvious that he does
NOT want to be found, and that Clinuvel doesn't want publicity.

https://www.linkedin.com/in/lachlan-h-22028...nNg7mOIvA%3D%3D

Surely, Clinuvel hates the spotlight this new analyst report puts on them. I understand why flying under the radar
does make sense to a certain extent. But it has reached an absurd level and they deserve a wake up call.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 29 2018, 09:22 PM


Group: Member
Posts: 482

I must say that I’m not impressed. Yes, it’s nice to see someone being appointed in the US but why her? She has absolutely no experience in this field besides being her father‘s daughter, may he rest in peace. Her resume is not that impressive, and she has no recent business experience. I would have liked to see Sean Parker or a similar hotshot filling this position.

What exactly makes her uniquely qualified ?
  Forum: By Share Code

FarmaZutical
Posted on: Jan 16 2018, 05:56 PM


Group: Member
Posts: 482

GG is not lost. Uho is tying to reach google and I’m helping him as best as I can.
I’m sure it will be back up shortly.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 5 2018, 05:14 AM


Group: Member
Posts: 482

He’s trying to get it back online but is having difficulties reaching Google.
It seems the guy who was spamming the group with adds for
various drugs got mad when his posts were deleted and probably
turned the group in for illegal content. The spam is deleted and
the suspension is ridiculous but it’s tricky getting in contact with Google.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 3 2018, 02:55 PM


Group: Member
Posts: 482

The British Porphyria Association ought to contact Ms. Lyons at the American sister organization.
She fought for EMA approval and surely she would be willing to help
with her expertise and experience in Britain, too.

https://www.facebook.com/groups/11092685227...79367792094717/
  Forum: By Share Code

FarmaZutical
Posted on: Jan 3 2018, 09:04 AM


Group: Member
Posts: 482

Yes, to the best of my knowledge that is the case.
When you read about New Methods it looks like
the process is halted because Clinuvel hasn’t yet provided
the health authorities with the relevant documentation.
I guess they went after the bigger fish, NICE first.
  Forum: By Share Code

FarmaZutical
Posted on: Jan 2 2018, 06:47 PM


Group: Member
Posts: 482

Nothing seems to have changed. Scenesse is still up for evaluation
in the “Nye Metoder” process and since Clinuvel hasn’t sent in the documentation
there is no progress. The hospital in Bergen initiated the review and seems
to be pushing for reimbursement.

The fact that Scenesse is not included in the list doesn’t change anything
as it is on a parallel track.

Norway’s system is not contingent on NICE. There are similarities
but they are not interconnected.
  Forum: By Share Code

FarmaZutical
Posted on: Dec 18 2017, 07:26 PM


Group: Member
Posts: 482

Post of the month
  Forum: By Share Code

FarmaZutical
Posted on: Dec 9 2017, 06:54 AM


Group: Member
Posts: 482

It’s worth remembering that Clinuvel asked the FDA if they wanted to
go with accelerated approval and surrogate endpoints. That is a de facto phase IV
after market entry. That was on the table but apparently they found another solution.
The EMA post marketing data is the last piece of the puzzle: proof of efficacy.
We will avoid further trials which would be unethical (as stated by the company) and
the FDA gets what it needs in order to (hopefully) approve. In this matter
Clinuvel is playing it safe and doing exactly what is needed.
  Forum: By Share Code

FarmaZutical
Posted on: Nov 24 2017, 11:01 PM


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Yes. But you can put on ignore :-)
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FarmaZutical
Posted on: Nov 24 2017, 08:11 PM


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Posts: 482

May I suggest that the board migrates to iHub. In anticipation of
US listing it would make sense, and there is an ignore button which
makes it very easy to avoid the nonsense flooding.

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FarmaZutical
Posted on: Nov 16 2017, 03:57 PM


Group: Member
Posts: 482

Just for the record: This “Thanks” was not intentional but
due to a fat thumb.
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FarmaZutical
Posted on: Nov 16 2017, 03:54 PM


Group: Member
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The great thing about iHub is that it has an ignore feature so you can
avoid the spam.
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FarmaZutical
Posted on: Oct 27 2017, 07:39 PM


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I agree. The FDA decides on whether to grant priority review during the
two months validation process. If Clinuvel is awaiting a desicion on that they must have filed the final module and thus
completed the dossier. I don’t see how a formal review could conclude “in the same year” with that being
2017, though.
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FarmaZutical
Posted on: Oct 27 2017, 02:15 AM


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Posts: 482

In the Roman mythology Artemis is called Diana and is also the moon
goddess. Would align with photo protecting albeit a bit
far fetched.
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FarmaZutical
Posted on: Oct 27 2017, 01:57 AM


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Posts: 482

Thanks a lot. Interesting. The fact that there was also stuff
related to Vallaurix bodes for its authenticity.

Do you remember anything about the Vallaurix texts ?
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FarmaZutical
Posted on: Oct 27 2017, 12:22 AM


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Posts: 482

I missed the logo thing. Someone found a logo of Artemis with Clinuvel’s name, right ? But it wasn’t on Clinuvel’s own site, was it ?
So we don’t know what it is or where it comes from, do we ? What did I miss ? Thanks.
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FarmaZutical
Posted on: Oct 21 2017, 05:54 AM


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Don’t feed the troll.
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FarmaZutical
Posted on: Oct 20 2017, 03:01 PM


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Welsh battle for Scenesse:

https://www.facebook.com/james.rawnsley/pos...327319874061022
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FarmaZutical
Posted on: Oct 16 2017, 05:52 PM


Group: Member
Posts: 482

Odi, die Person, die Sie beantworten, hat keine wirklichen Absichten. Er ist nur hier, um Ärger zu machen. Alles, was er schreibt, ist negativ, um unter anderem Uneinigkeit und Zweifel zu erzeugen. Entweder bekommt er dafür Geld, oder er ist eine sehr traurige Seele, die keine Aufmerksamkeit hat. Vielen Dank für Ihre Beiträge. Ich würde keine Zeit damit verschwenden, auf diese Person mehr zu reagieren, wenn ich Sie wäre. Mit freundlichen Grüßen, Farma
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FarmaZutical
Posted on: Sep 24 2017, 09:47 PM


Group: Member
Posts: 482

Thank you so much, Odi. Great info.

With Germany ramping up, the number of implants sold will
clearly increase significantly. If they plan to open an additional
30 centers it must mean that they are aiming to treat a lot
of patients. Roughly, 400 patients treated in Germany alone
would be enough to double the pps from here IMO.

I think the info from this meeting should be communicated by
the company, as it is clearly of value to the market.
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FarmaZutical
Posted on: Sep 24 2017, 05:54 PM


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Posts: 482

Hey Odi,

Thanks a lot for the info. Much appreciated.

Just to clarify: Did you attend the meeting ? Can you add anything
regarding the mood of the Clinuvel representatives present ?
And 30 centers in Germany sounds like a lot. What did they
say about the nature of these centers and the timeframe ?
Did they mention anything about additional countries coming online anytime
soon ?

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FarmaZutical
Posted on: Sep 16 2017, 06:14 PM


Group: Member
Posts: 482

While it's a possibility the FDA rarely performs a review of the
modules they receive in a rolling basis. The most common
procedure is that the clock and review commence once the 5th module is
lodged and the validation a fact. It's entirely possible that the FDA
has already reviews the already lodged modules and is ready to
perform a speedy review of the entire NDA, but I am not at all
counting on it.

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FarmaZutical
Posted on: Sep 16 2017, 03:28 AM


Group: Member
Posts: 482

That was before Lachlan secretly changed the filing deadline to year's end at the latest.

If Clinuvel lodges the final module by January 1st 2018 I would say that the

best possible scenario is a PDUFA date October 1st.


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FarmaZutical
Posted on: Sep 11 2017, 01:10 AM


Group: Member
Posts: 482

News from Norway. Still no progress on reimbursement.

Google translated:

New in research on EPP

The latest in erythropoietic protoporphy (EPP) research was presented at an international porfy conference in Bordeaux this summer. Among other things, an update was presented on the use of Scenes in clinical practice. In addition, there are other drugs under investigation, but in a very early phase. Two quality life studies were also presented.

Published 05.09.2017
Conference facilities

Experiences with the use of Scenes (afamelanotide)
Scenesse is a new drug that will give the skin an increased tan and thus protect the skin against the harmful rays of the EPP. Janneke Langendonk from Erasmus University Rotterdam presented data from 105 EPP patients in the Netherlands where Scenesse has been prescribed.

Patient feedback is positive in terms of effect, but it varies greatly from person to person. A patient left on his own initiative to use Scenesse when he lost the "stinging feeling" which was a warning that he / she had received too much sun, which made it difficult to get away from the sun in time.

The practical experience in terms of effect is good, but there are challenges in relation to getting the drug. The drug itself is a small "rod" that is to be carried under the skin, and the procedure itself should be quick and easy to implement. But Scenesse is approved under so-called «exceptional circumstances». This means that the drug will be given at an approved center with special expertise in porphyry disease.

In addition, there is a comprehensive protocol to be completed, a physical examination must be done, all skin must be photographed, blood and urine samples and liver ultrasound must be taken. All information about the surveys, plus questionnaires to the patients, will then enter an international register. In practice, it appears that a patient spend almost an entire day at the hospital for the first time the drug is given in the season.

Another major obstacle in many countries is the price of the drug itself and the costs associated with getting the drug. So far, only the Netherlands has received a refund for the costs, but the drug is also available in Germany, Switzerland and Italy (PL9).

In Norway there is an application for "New Methods" to be allowed to prescribe this at Norwegian hospitals, and we hope for an early response to this.

New possible future treatments
Two Swiss research groups are working on developing gene therapy to correct the mutated EPP gene. They have developed methods for introducing the "fresh" gene into a mouse model with EPP. EPP mice who have had such a healthy gene seem to tolerate this well and have less light sensitivity.

However, a lot of research and testing remains to be considered before assessing whether this is suitable for human use (PL 8 and OC16).
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FarmaZutical
Posted on: Aug 11 2017, 04:59 PM


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Posts: 482

This says it all.

http://fb.me/8n8owyMze
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FarmaZutical
Posted on: Aug 11 2017, 01:48 AM


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Posts: 482

In regard to the SMC advice being withheld I received an answer to my inquiry:

"The SMC advice is withheld as the company have not yet launched the product in the UK and thus it is not at this time in Scotland."

Seems they are wating for NICE.







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FarmaZutical
Posted on: Aug 8 2017, 04:11 PM


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Posts: 482

Also a possibility. Hopefully, they will resolve it before NICE decides.
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FarmaZutical
Posted on: Aug 8 2017, 03:55 PM


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Posts: 482

Could be. But the language could also just be a cover for negotiations taking
place. In the first example I posted with similar language the company resubmitted
within two months and got approval. I think Clinuvel is about to resubmit
with a better economic case - or they are still negotiating a rebate.

From the SMC website about reasons for non approval:

Not sufficiently strong economic case.
This is a common reason for non-approval and one which is often misunderstood. Very high cost per QALY figures may be why the economic case is rejected. Sometimes it is because the SMC feels that wrong assumptions are made in the submission. In this case the company may decide to resubmit to address any shortcomings that SMC may have highlighted in the economic case and which prevented them from accepting the medicine for use.
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FarmaZutical
Posted on: Aug 8 2017, 03:46 PM


Group: Member
Posts: 482

I think I know what's going on in Scotland.

The round table probably went well and the company
presented a good case. But the SMC thinks the price is too
high and demands a PAS with a discount. The company is
reluctant to give a discount because it would set precedent
before the real battle with NICE takes place. On the other hand,
a victory in Scotland could put pressure on NICE because they don't
want to see uneven access to medicine throughout the Kingdom.
So right now Clinuvel is probably trying to design a model
like the one we're seeing in Italy. Or they will come back and refuse
to give a discount. Scenesse is already EMA approved so
withholding the advice due to "product availability" doesn't make sense.
It probably means that the product will only be available if the
price negotiations conclude in a rebate, but they can't write that online.
I hope Clinuvel concedes. We need Scotland (and Wales) to take England.
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FarmaZutical
Posted on: Aug 8 2017, 03:06 AM


Group: Member
Posts: 482

And another drug that wasn't commercially available when the
first submission was made. Close to approval they resubmitted
and got another review. It seems that the SMC is treating Scenesse as if
it's not even EMA approved yet. Strange.

https://www.scottishmedicines.org.uk/SMC_Ad...ra_Resubmission
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FarmaZutical
Posted on: Aug 8 2017, 03:03 AM


Group: Member
Posts: 482

Another example. But with a resubmission.

https://www.scottishmedicines.org.uk/SMC_Ad...enidone_Esbriet
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FarmaZutical
Posted on: Aug 8 2017, 02:59 AM


Group: Member
Posts: 482

This is an example of a full submission to the SMC that was initially
withheld due to "product availability" in April, 2009. It was published two months later
in July, 2009. And as we can see, it's positive.

https://www.scottishmedicines.org.uk/files/...for_website.pdf
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FarmaZutical
Posted on: Jul 20 2017, 04:08 PM


Group: Member
Posts: 482

It's not about a delayed news letter. Or the fact that they want to tip toe because of competition.

Lachlan sits on information that is still not released to the general market: The delay
of the NDA. He gives an interview to a an obscure magazine behind a pay wall but says
nothing to us. Don't tell me that FIL, Lagoda and the other big boys didn't get this
info spoon fed before Lachlan gave the interview. It's just one more example of their
contempt for retail investors.

I think Frogsters post is very constructive and relevant and will support
any attempt to get managements attention. An article in one of those
Australian news papers would be nice too.
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FarmaZutical
Posted on: Jul 19 2017, 11:31 PM


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Posts: 482

Obviously I ment 2019 or late 2018 if we're lucky. Sorry.
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FarmaZutical
Posted on: Jul 19 2017, 10:36 PM


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Posts: 482

That was my estimate before Lachlan secretly announced the 6 months delay.
Now, I don't expect PDUFA before 2018. Late 2017 if we're lucky.
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FarmaZutical
Posted on: Jul 19 2017, 08:14 PM


Group: Member
Posts: 482

I think it's time that shareholders voice their concern as a group.
It's part of being an active investor and totally legit. I'm sure many of us have already
written the company with no results, so I suggest a joint letter to get their attention.

We are here because we believe in the product and to some extent
management. They have done many things right but the continued disrespect
for retail investors is outrageous. The 6 months delay of the NDA should have been
communicated to us before giving an interview to a subscription only
publication. The fact that Whales turned down Scenesse in a preliminary
hearing should also have been communicated. And announcing a bi-monthly
newsletter as a hoax is disrespectful I appreciate that they need to keep
all sensitive information close but since they are traded on the ASX and not yet a private company
there are rules to be followed and basic decency to live up to.
I'm sure the big investors are kept in the loop while they blatantly
leave all of us hanging.

It's obvious that they see retail investors as an obstacle but in that case they
should take the company private. Otherwise, we deserve some respect.
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FarmaZutical
Posted on: Jul 17 2017, 05:56 PM


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Posts: 482

Not a patent. A brand name. Big difference.
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FarmaZutical
Posted on: Jul 17 2017, 04:45 PM


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Posts: 482

I am invested in this company because I like the product and
the prospects. I respect the CEO for what he has managed to
pull off despite the obstacles. You don't need to like everything about a
company in order to invest in it, and I absolute hate their attitude towards
smaller investors. It's clear that they only respect the institutional investors and
that they despise the smaller ones. They probably feed the big investors
info like the delayed FDA filing that was only mentioned in an article
behind a pay wall. The companys PR strategy is to do as little as possible
without breaching ASX rules. I do think, though, that it's a violation of ASX
rules to delay the FDA filing with 6 months in an article that is not accessible to the
general market. It's very disrespectful at the least. The bi-monthly newsletter
is a hoax. They don't want to tell us anything and they generally hate that we are
even here. FIL, Lagoda and Sean Parker all know exactly what is going on and what
the strategy is. I'll stay invested because I have a feeling that the product(s) will one day be
big and that management will eventually learn to steer the boat. I have to live with their
attitude along the way.
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FarmaZutical
Posted on: Jul 4 2017, 06:59 AM


Group: Member
Posts: 482

So Clinuvel is not able to host discussions about specific company treatments on its
Facebook page, yet Akash posted these to updates recently.
They are truly amateurs at Clinuvel. Inconsistent and blatantly
in contempt of their shareholders.
Attached thumbnail(s)
Attached Image

Attached Image


 
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FarmaZutical
Posted on: Jul 4 2017, 03:33 AM


Group: Member
Posts: 482

Well, today Lachlan's PR guy posted this after deleting the
posts from a couple of Swedish ladies about Scenesse now
being available in Sweden.

Clearly, they want as little PR and as little discussion about Scenesse as possible.
It's amazing that Clinuvel's PR person is in fact actively seeking to
limit the knowledge about the company.

Meanwhile, Lachlan gives an interview to a publication that is
only accessible to paid subscribers where he reveals that
the company will not live up to the announced FDA filing timeline.
I'm pretty sure it's in violation of the ASX rules.
Attached thumbnail(s)
Attached Image


 
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FarmaZutical
Posted on: Jun 19 2017, 09:16 AM


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Posts: 482

You're right. I probably misread it the second way round.
It does seem like they pulled it.
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FarmaZutical
Posted on: Jun 19 2017, 08:21 AM


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Posts: 482

According to this link we should probably not expect
that Wales will recommend Scenesse.

https://ojrd.biomedcentral.com/articles/10....3023-016-0501-4
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FarmaZutical
Posted on: Jun 19 2017, 06:24 AM


Group: Member
Posts: 482

Having read the text again, I think Scenesse is actually up
for appraisal this coming Wednesday. I expect that Clinuvel will be present at the
meeting and that we'll get a PR next week. It seems the procedure
is very swift and that they will make the decision on the spot. Cross your fingers boys and girls.
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FarmaZutical
Posted on: Jun 19 2017, 06:11 AM


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Posts: 482

Actually, we're living in the 21st century.
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FarmaZutical
Posted on: Jun 18 2017, 06:53 PM


Group: Member
Posts: 482

AWMSG in relation to NICE

The National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG) have a shared interest in the drive to improve patient access to new medicines and treatments. Both organisations recognise that by working together they can enhance and develop timely, independent and authoritative guidance on new medicine and/or new licence indications or formulations for existing medicines, and on the cost implications of making them routinely available on the NHS.

In May 2012, a memorandum of understanding was agreed which formally sets out a collaboration between NICE and AWMSG. The Memorandum sets out the circumstances in which NICE and AWMSG will work together and includes the appraisal work programme (scheduling), implementation, support of guidance, patient access schemes and value based pricing. The aim is to join up the strategic planning, development and delivery of guidance in England and Wales, avoiding duplication or conflict of work, yet complementing and supporting the work of NICE and AWMSG.

Appraisals

Medicines are funded by NHS Wales following guidance from two source, AWMSG and NICE. AWMSG will take into account the NICE future work programme when considering whether a medicine will be appraised. 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. AWMSG advice, is interim to NICE guidance should this be subsequently published.

In the absence of AWMSG or NICE guidance individual prescribers should exercise their clinical judgement unless there is evidence not to do so in the light of particular circumstances of an individual patient.
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FarmaZutical
Posted on: Jun 18 2017, 06:48 PM


Group: Member
Posts: 482

It seems, Scenesse was up for appraisal by the AWMSG on the coming meeting Wednesday but that
Kalydeco took its place.

Read the minutes from the previous meeting and compare with the agenda
for the meeting on June 21st.

http://www.awmsg.org/meetingszip/AWMSG%20m...ng%20papers.pdf
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FarmaZutical
Posted on: Jun 14 2017, 05:11 AM


Group: Member
Posts: 482

Could someone please write an email to this journalist and let him
know that there is a drug on the marksd that does this and that the company
has an office in London.
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FarmaZutical
Posted on: Jun 9 2017, 10:58 PM


Group: Member
Posts: 482

I thought for some to consider: if Clinuvel were a privately owned company and you got the chance to buy in, would you do so?
The daily share price does not necessarily reflect the true value of a company but it can be a source of tremendous frustration if you apply to much value to it.
If we had all been investors in the privately held Clinuvel, the only thing that would matter would be the price at which you bought in and subsequently your exit.
It makes no sense to discuss the daily fluctuation or to constantly hope for an up list to the NASDAQ.
Clinuvel is only suited for buy-and-hold. Many other stocks out there for you to trade.
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FarmaZutical
Posted on: Jun 7 2017, 04:21 AM


Group: Member
Posts: 482

Don't expect too much. They don't have a PR person and their
strategy is non communication.
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FarmaZutical
Posted on: May 31 2017, 11:56 AM


Group: Member
Posts: 482

I do think we are getting close, but it would be normal to do a PR
when the NDA is complete so we're not there yet, IMO. Module 1 is region specific and parts
of this module can be submitted at any time. The 4 remaining modules
will probably look a lot like the EMA dossier, but one of the advantages
of rolling submission is more intensive communication between the sponsor and the FDA
so Clinuvel will adjust here and there to meet the needs and
demands by the FDA at this stage.
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