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CUV88
Posted on: Nov 8 2018, 02:59 AM


Group: Member
Posts: 187

Good sign. As far as i know there were no trials in Canada? So could be preparation for FDA or even requirements from the FDA to get the doctors accredited.
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CUV88
Posted on: Oct 31 2018, 08:40 AM


Group: Member
Posts: 187

Noticeable Increase up to 1,3m in the Forecast for Product manufacturing and operating costs. OTC or Scenesse? Eitherway good sign
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CUV88
Posted on: Oct 29 2018, 09:32 AM


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Posts: 187

Announcement published just now
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CUV88
Posted on: Oct 19 2018, 05:10 PM


Group: Member
Posts: 187

Phase 3 for HHD also possible?

QUOTE
The phase II trial of Scenesse in HHD follows on from the first proof-of-concept pilot trial in 2012.

During this study, two HHD patients with long-lasting lesions and ulcerations were treated with Scenesse. Their lesions disappeared after day 60 and only started to reappear eight months after the completion of treatment.

“We are pleased with the results of the pilot study and look forward to the outcome of this longer-term study,” Clinuvel acting Chief Scientific Officer Dr Dennis Wright said. “We hope that afamelanotide provides a major therapeutic breakthrough for HHD patients who do not have any effective treatment.”


https://www.labonline.com.au/content/life-s...n-hhd-451320431
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CUV88
Posted on: Oct 19 2018, 03:38 PM


Group: Member
Posts: 187

My highlight:

QUOTE
A third indication will be announced after the print of this Annual Report, pending ethics, regulatory and clinical agreements with the study centre. This new indication has been prepared for more than five years and we are in the final stages of starting to evaluate SCENESSE® in patients with a genetic affliction.
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CUV88
Posted on: Oct 19 2018, 05:31 AM


Group: Member
Posts: 187

A short squeeze could push us to another ATH, lets see
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CUV88
Posted on: Sep 26 2018, 01:45 PM


Group: Member
Posts: 187

Next rebalance for ASX200: 21. December. Lets hope we keep up the momentum until then👍🏼
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CUV88
Posted on: Sep 25 2018, 04:20 PM


Group: Member
Posts: 187

I also think we still are below fair value. But i agree with xray the chart is not saying the market all of a sudden calculated fair value. Looks more like take over / new insto. Or do you guys think the new publicity in new york had that impact?
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CUV88
Posted on: Sep 21 2018, 11:17 PM


Group: Member
Posts: 187

8th October first day Clinuvel Dividend Payout and also Aston Martin IPO, coincidence? Who can see the connection 😄
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CUV88
Posted on: Sep 20 2018, 02:51 AM


Group: Member
Posts: 187

Hopefully we can expect a 88day letter today... would love that number
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CUV88
Posted on: Sep 8 2018, 12:23 AM


Group: Member
Posts: 187

Hi Peter,

welcome onboard! Thanks for all the extensive work you put into the analysis and reports. I think your publications are the only holistic reports out there.

Best regards
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CUV88
Posted on: Sep 5 2018, 04:06 PM


Group: Member
Posts: 187

trolling review
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CUV88
Posted on: Sep 5 2018, 12:45 PM


Group: Member
Posts: 187

WTF Clinuvel..... really?
Constant communication with the FDA to finally figure this out?

„... although at this stage further timelines have not been provided by the FDA...“

Perfect scenario, now they can keep us in the dark again and we dont know for how long.
Days, Months, Years?

I really thought we were over this Delay crap
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CUV88
Posted on: Aug 29 2018, 02:38 AM


Group: Member
Posts: 187

Volume of only 200?
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CUV88
Posted on: Aug 27 2018, 09:32 AM


Group: Member
Posts: 187

From the same announcement:
QUOTE
Pending validation of the NDA dossier, and allocation of priority or standard review...


I guess its only about the NDA beeing submitted, not accepted
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CUV88
Posted on: Aug 25 2018, 05:28 AM


Group: Member
Posts: 187

If NDA is rejected, then CUV would have to adjust and refile the NDA or add a new trial. etc. etc. VERY UNLIKELY ... we have fast track and rolling review with constant communication between the company and the FDA. I dont think PW would file a dossier that was that sucky. Worst case in my opinion is we get standard review with delays
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CUV88
Posted on: Aug 23 2018, 05:09 PM


Group: Member
Posts: 187

Scenarios:
QUOTE
Filing Communication: If the application is filed, the RPM issues a Filing Notification letter by day-60 for priority NDAs and all BLAs. The RPM also prepares a Filing Communication (the day-74 letter) describing deficiencies, filing review issues (See CDER MAPP 6010.5) and the final review designation. The RPM notifies the applicant of a priority review designation in writing by day-60, or of a standard review by day-74 (in the Filing Communication).
For a Priority Review, the RPM prepares one of the following three communication types:
1. If there are filing issues but they are not ready to send to applicant by day-60, send the “Priority Review Determination” letter by day-
60 then send the “Filing Issues Identified” Letter by day-74.
2. If there are filing issues and they are ready to send to the applicant by day-60, send the “Filing Issues Identified” letter by day-60.
3. If there are no filing issues, send the “No Filing Issues Identified” letter to the applicant by day-60.
For a Standard Review, send either the “Filing Issues Identified” letter or the “No Filing Issues Identified” letter to the applicant by day-74. A single letter can be used to satisfy both the day-60 and day-74 requirements. The filing communication gives the applicant early notice of any
review issues identified to this point. This communication also identifies review timelines (See Planning Meeting section below). The planned review timeline included in the day-74 letter for applications in the PDUFA V “Program” will include the planned date for
the internal mid-cycle review meeting and preliminary plans on whether to hold an Advisory Committee (AC) meeting. For expected expeditedapplications,thedategivenfortheinternalmid-cyclereviewwillalignwiththeexpeditedreviewtimeline. Thedates
provided for communication of PMRs/PMCs and labeling will still conform to 21st Century Review timelines, with a note that the review team will communicate revised dates if the review continues on an expedited timeline.


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

Page 21
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CUV88
Posted on: Aug 23 2018, 04:48 PM


Group: Member
Posts: 187

So 60 days NDA review time are over. I guess PW already got a short indication of what the FDA decided. Does anybody expect an announcement before the 74day letter including the official PDUFA Date? I do not ... hoping but not expecting anything
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CUV88
Posted on: Aug 11 2018, 02:24 AM


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Posts: 187

Whooow! ... „REPAIRING DNA“ !?!??
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CUV88
Posted on: Aug 7 2018, 03:29 AM


Group: Member
Posts: 187

User: paramour01

QUOTE
Clinuvel actively seeking global acquisition opportunities up to $300m (have looked at various potential targets but couldn't agree favourable valuations with sell-side) and Wolgen has confirmed the company has satisfied all internal criteria for a US IPO.

Should expect more public news on US listing from management towards latter stages of NDA review process.


There was no Source or proof... so i guess nobody thought it was worth discussing
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CUV88
Posted on: Aug 5 2018, 03:39 AM


Group: Member
Posts: 187

Attached Milestones ahead - Still awaiting vitiligo, pilot and product line
Attached thumbnail(s)
Attached Image


 
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CUV88
Posted on: Jul 31 2018, 04:39 PM


Group: Member
Posts: 187

NDA Feedback on 22. August, i guess no news on new Product line before
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CUV88
Posted on: Jul 31 2018, 08:47 AM


Group: Member
Posts: 187

Even worse: the IPPN describes a member (same?) as Vice President from Biogen, which could be a conflict of interest in the area of MS or other inflammatory / autoimmun diseases
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CUV88
Posted on: Jul 23 2018, 09:34 PM


Group: Member
Posts: 187

https://edition-m.cnn.com/2018/07/20/health...ww.google.de%2F
QUOTE
An injectable tan
Another manufacturer turned to a photoprotective substance closer to home, a hormone our bodies release in response to UV radiation in order to stimulate melanin production. In other words: a tan.
Clinuvel, an Australia-based company, has an injectable product on the market in Europe called Scenesse that contains an analog of this hormone, and the company recently submitted an application to the FDA for its use to treat a rare disorder that causes severe intolerance of light.
The injection is offered in Europe only for patients with this rare genetic disease, but a clinical study is underway in Singapore on Scenesse's effect on patients with vitiligo, a common skin condition.
Some dermatologists expressed concerns about Scenesse's potential side effects.
"I really do worry about unpredictable consequences of what else it's doing in the body," Linden said.
Leffell said that anything that turns on the body's pigmentation pathway makes him nervous, since the cells that produce melanin are also the ones that become cancerous in melanoma, a rare but dangerous form of skin cancer.
That concern is simplistic, Clinuvel CEO Dr. Philippe Wolgen said, since darker pigmentation can be a symptom of melanoma and not its underlying cause.
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.
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CUV88
Posted on: Jul 14 2018, 01:33 AM


Group: Member
Posts: 187

http://covenantcompanion.com/2018/07/12/co...into-the-light/
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CUV88
Posted on: Jul 12 2018, 03:43 AM


Group: Member
Posts: 187

Hey Clinuvel, we are bored please share your new product line now that the NDA is out!
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CUV88
Posted on: Jun 29 2018, 07:35 PM


Group: Member
Posts: 187

Well since 6,700 > 5,100 is mathematically true the first announcement could even mean 6,700 :D ... CUV style
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CUV88
Posted on: Jun 22 2018, 09:58 PM


Group: Member
Posts: 187

Couldnt they just announce the announcement on monday? I really hope we will get an update when the US market opens. Otherwise we are left to speculate the whole Weekend
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CUV88
Posted on: Jun 22 2018, 03:48 AM


Group: Member
Posts: 187

Everything takes ages, but I admire Clinuvels endurance in regulatory battles. Also it seems they fight for every single patient, good for Karma
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CUV88
Posted on: Jun 1 2018, 05:53 PM


Group: Member
Posts: 187

I think its too much speculation. Still convinced there will just be an announcement, when NDA submitted. Its too important to not just communicate it
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CUV88
Posted on: May 28 2018, 06:36 PM


Group: Member
Posts: 187

I think it is just wrong wording. I expect an official announcement within the next 5 weeks when NDA finally is submitted.
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CUV88
Posted on: May 24 2018, 01:56 PM


Group: Member
Posts: 187

QUOTE
In the immediate future we will launch a product line for comprehensive skin care which will serve us under extreme
conditions.


... extreme conditions ...

http://clinuvel.com/clinuvel/company-overv...tory-and-future

#iggypushdown
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CUV88
Posted on: May 23 2018, 01:24 PM


Group: Member
Posts: 187


Pills that say they protect you from the sun might not actually work, FDA says
The Food and Drug Administration sent warning letters to five products marketing pills and capsules that make unproven claims they protect consumers from the sun.
It cited these products: Advanced Skin Brightening Formula, Sunsafe Rx, Solaricare and Sunergetic.
FDA Commissioner Scott Gottlieb says no pill or capsule can replace your sunscreen.

https://www.cnbc.com/2018/05/22/fda-says-st...-suns-harm.html

Yearly News on how we dont have any proper sun protection besides sunscreen.
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CUV88
Posted on: May 16 2018, 03:17 PM


Group: Member
Posts: 187

Like some here have suggested it is unlikely the product line planned to be launched this year includes a melanin increasing hormon. That would need some trials. Or ist there a way to get it on market in asia without authorities?
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CUV88
Posted on: May 15 2018, 12:46 PM


Group: Member
Posts: 187

Yeah the implant will then be available in a Set with a Scenesse-Gun for self implantation. I thought about this one as well... oh maybe we need some liquor in that pakage for the pain, i prefer vodka
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CUV88
Posted on: May 14 2018, 01:22 PM


Group: Member
Posts: 187

„New communication“ left shareholders in the dark for more than a month to finally disappoint about NDA progress. Reminds me of EMA: delay!
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CUV88
Posted on: May 13 2018, 03:47 AM


Group: Member
Posts: 187

40k
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CUV88
Posted on: Apr 21 2018, 03:04 AM


Group: Member
Posts: 187

The facebook campaign for EPP #IPAW2018 is a very smart marketing move. It seems like everybody who uses the facebook link gets automatically assigned to #clinuvel in instagram. Just check it out, im actually impressed by this one!!!
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CUV88
Posted on: Apr 20 2018, 04:48 PM


Group: Member
Posts: 187

What do you think who could buy us?
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CUV88
Posted on: Apr 20 2018, 03:49 PM


Group: Member
Posts: 187

Sure it is nice to see the SP increasing, but why? NDA runup, take over, coverage in germany? NDA is still not communicated.Usually this would result in some stagnating or even falling price. Anyway, good to have a higher base for NDA&FDA
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CUV88
Posted on: Apr 17 2018, 02:34 AM


Group: Member
Posts: 187

QUOTE
SUMOylation (uncountable)

(biochemistry) The process whereby SUMO proteins attach themselves to other proteins within cells and modify their function.


https://en.m.wiktionary.org/wiki/SUMOylation#English

Maybe far fetched, but might have a connection?

Since theres a Version like T’Sumoyle

https://en.m.wikipedia.org/wiki/SUMO_protein
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CUV88
Posted on: Apr 16 2018, 08:48 PM


Group: Member
Posts: 187

QUOTE
We are pleased to announce today the launch of the CLINUVEL Instagram channel. Click to visit our profile, and follow us to stay up to date with our skin and photoprotection posts: http://ow.ly/7Ppw30jvzfD
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CUV88
Posted on: Apr 10 2018, 04:58 AM


Group: Member
Posts: 187


QUOTE
In April and May, CLINUVEL will publish three successive SCIENTIFIC COMMUNIQUÉS to review the current understanding and progress in proopiomelanocortin (POMC) science and photomedicine. SCIENTIFIC COMMUNIQUÉ I provides an outline of the various physiological modifications taking place on proteins and the clinical relevance to our technology programs. In SCIENTIFIC COMMUNIQUÉ II we will delve into how ligands bind to the various cellular receptors, signalling cascades and output to arrive at therapeutically meaningful applications. In SCIENTIFIC COMMUNIQUÉ III we will review the effects of afamelanotide, CLINUVEL’s lead drug, on the human genome. After the COMMUNIQUÉS we hope the reader will be able to grasp the, often opposing, opinions found in the abundance of literature on relevant topics.


http://www.clinuvel.com/photoprotection-ex...ic-communique-i
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CUV88
Posted on: Apr 7 2018, 03:19 PM


Group: Member
Posts: 187

Just not true, Clinuvel had a take over attempt in 2014 prior FDA even prior EMA. ( not an answer to iggy since he knows this very well, but all new readers )

BTW interesting to see what were the numbers back then:

QUOTE
Drug developer Clinuvel Pharmaceuticals has received an unsolicited $95 million takeover offer from controversial, NASDAQ-listed drug company Retrophin, which has sent its share price soaring by 28 per cent.

Retrophin, which has a market capitalisation of $US281 million ($299 million) and is run by a former hedge fund trader, has proposed a complete takeover. It has offered either 0.175 Retrophin shares for each Clinuvel share, which is equivalent to $2.14 a share, or $2.17 in cash per share.


https://www.smh.com.au/business/clinuvel-re...0728-zxlj6.html
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CUV88
Posted on: Apr 6 2018, 02:30 AM


Group: Member
Posts: 187

Also cant buy a soccer team if you are too old or dead.
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CUV88
Posted on: Mar 19 2018, 02:00 PM


Group: Member
Posts: 187

BTW 10.49aud!!! Whooow what a nice momentum today!!
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CUV88
Posted on: Mar 19 2018, 01:57 PM


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Posts: 187

Yes, no matter how long you hold... we used to have no tax on long term holdings before 2009. If you bought before that its free, later its kind of flat tax with around 25% for private individuals
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CUV88
Posted on: Mar 19 2018, 01:06 AM


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Posts: 187

In Germany its 25% tax on the profit at the moment you sell
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CUV88
Posted on: Mar 10 2018, 08:06 AM


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Posts: 187

Fuck you iggy, get lost
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CUV88
Posted on: Mar 7 2018, 03:28 AM


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Posts: 187

Well well, hopefully B&S will do the marketing of our new product line then wink.gif
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CUV88
Posted on: Mar 1 2018, 08:58 AM


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Posts: 187

Some Positives:

- Clear milestones with dates communicated, and until now met
- Today already 3 posts in the Clinuvel Facebook group
- Spain seems to be online in some way (why no announcement?)

So they seem to get started with communications
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CUV88
Posted on: Mar 1 2018, 08:26 AM


Group: Member
Posts: 187

Also it is not that expensive to create a professional NEW website nowadays. Why did they just change the colors and logos? Ultra low budget....I really hope they are not going to squeeze a webshop into that template for the new product line.

Please Clinuvel get a new website build from scratch by a professional team! Include IT, Design & Marketing specialists...
And I also liked the old logo alot more... i want it back
By the way, for the new communication strategy i would like to see new promo videos like Clinuvel already used to have (last upload in the „photoprotection channel“ on youtube was 5 years ago) and regular investor calls, thanks
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CUV88
Posted on: Feb 20 2018, 12:06 PM


Group: Member
Posts: 187

In that page it also explains, the boards / writers opinion on the rebranding:

QUOTE
For CLINUVEL, it’s also time for a makeover as the company moves from research and development phase to commercialising its pharmaceutical pipeline.Last year CLINUVEL chalked up $12m of revenue from SCENESSE®, which is approved for use by the European Medicines Agency for the debilitating light intolerance, disorder erythropoietic protoporphyria (known as EPP)1.But the CLINUVEL name remains. For CLINUVEL, reinvention is nothing new, given the company shed its original name of EpiTan. This measure was much more than skin deep, given the company’s decision to move from developing a safe-tanning drugs to tackling some of the most serious skin disorders such as EPP. For CLINUVEL, it was a case of management mulling how the company would like to be defined now and in the long run. Thus the branding is a mere reflection of that thought process, the underlying philosophy being the company’s successes to date does not justify retaining the status quo. It will be interesting to see whether the subtle repositioning rubs off directly on CLINUVEL’s valuation and investor attitudes. The company can’t – and doesn’t – expect a ‘one day wonder’ re-rating on the back of it. More likely the share price will take care itself after further clinical and sales success: the result, in turn of the corporate philosophy espoused by the rebranding. Ultimately, by maintaining robust and well-executed values, pharma companies such as CLINUVEL will attract investors attracted not just by the existing technology and products, but management’s thought processes and integrity. That way, management can be confident of support for tomorrow’s innovations rather than just today’s. The danger, of course, lies with companies straying from these values and trashing their market brand. If it’s thoughtfully executed, a branding tweak can work wonders even for a well-established consumer brand – and it doesn’t need to involve changing an existing name and logo. Take McDonald’s, which a decade or so ago was seen as a stale fast-food chain selling unhealthy foods from shabby outlets. Simple measures such as introducing healthy options and overhauling the restaurant led to a sales turnaround – all without touching the golden arches. For a biotech not selling directly to the consumer market, a subtler approach is required. But a makeover can be highly effective – as long as it genuinely correlates with the company’s corporate philosophy and direction.


http://clinuvel.com/social-media/monthly-viewpoints
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CUV88
Posted on: Feb 3 2018, 11:43 PM


Group: Member
Posts: 187

So any guesses for the Clinuvel "Skincare Solutions"? It is definitely not going to be a melanocortin based creme. Also i guess Clinuvel will first tackle a special group, maybe they also choose some orphan disease?

My ideas would be:

- Additional creme for EPP that blocks relevant UV spectrum 400nm
- Skin Care solution for another disease e.g. psoriasis
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CUV88
Posted on: Feb 2 2018, 05:47 PM


Group: Member
Posts: 187

If i understand the relative milestone timeline from the AGM right we first have:

1. EMA Annual Report to FDA
2. Company positioning new website & communication
3. CUV103 vitiligo results
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CUV88
Posted on: Feb 2 2018, 04:51 PM


Group: Member
Posts: 187

https://www.europeanpharmaceuticalreview.co...erapy-vitiligo/

Researchers have successfully applied a novel combination therapy to restore skin colour in patients with vitiligo

QUOTE
Building on prior research that examined the use of an arthritis medication to treat vitiligo, a team of Yale dermatologists has successfully applied a novel combination therapy — the medication and light — to restore skin colour in patients.

Dr Brett King Associate Professor of Dermatology and his colleagues reported two cases of patients with significant loss of skin colour from vitiligo, a chronic autoimmune disease that destroys skin pigment, leaving white splotches where there had been colour. For Dr King’s patients, standard treatments, such as steroid creams and light treatment, had failed to restore pigmentation.

To address these difficult cases, the research team combined the medication, tofacitinib, with narrowband ultraviolet B light therapy. In recent experiments, King and Dr John Harris, a dermatologist at University of Massachusetts-Worcester, had shown that tofacitinib keeps the immune system from attacking the skin cells that manufacture melanin pigment (colour), and light stimulates pigment-making cells to restore colour to the skin.

After a few months of the combination therapy, there was a remarkable improvement, report the researchers: One patient saw the near-total restoration of skin colour on her face, neck, chest, forearms, and shins. The other patient experienced similar success.

While more research is needed, the study highlights another advance by the Yale team in treating this and other stigmatising skin conditions. “These findings will define the treatment of vitiligo in the future,” Dr King said.

The study has been was published in JAMA Dermatology.
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CUV88
Posted on: Dec 29 2017, 01:14 AM


Group: Member
Posts: 187

Maybe the PASS data from the EMA which was expected for december is encouraging
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CUV88
Posted on: Dec 5 2017, 04:03 PM


Group: Member
Posts: 187

Why only two weeks, i think we have a lot of time in 2018 for learning german. A few month before NDA and also afterwards.

Greetings from our Mr wal(nu)tz
Attached thumbnail(s)
Attached Image



 
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CUV88
Posted on: Nov 25 2017, 06:41 AM


Group: Member
Posts: 187

We already had 7$ on 7. November
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CUV88
Posted on: Nov 24 2017, 10:27 PM


Group: Member
Posts: 187

Just migrated, love the ignore functionality, thanks!
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CUV88
Posted on: Nov 24 2017, 08:58 AM


Group: Member
Posts: 187

Its not A guy, its THE guy. But if you have a better explanation i am curious about it.
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CUV88
Posted on: Nov 24 2017, 08:58 AM


Group: Member
Posts: 187

Its not A guy, its THE guy. But if you have a better explanation i am curious about it.
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CUV88
Posted on: Nov 24 2017, 08:43 AM


Group: Member
Posts: 187

AGM will not have any effect on the SP, since the interested audience stays the small old group. Triggers are NDA/Prio Review and the approval itself. Current runup is caused by Mr. Homm. I hope all questions answered...

You naughty boy
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CUV88
Posted on: Nov 6 2017, 04:53 PM


Group: Member
Posts: 187

Hi xray, do you actually have an idea on what is happening? I think you are one of the few who could have some insights
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CUV88
Posted on: Nov 4 2017, 02:11 AM


Group: Member
Posts: 187

https://blogs.fda.gov/fdavoice/index.php/20...xpanded-access/

QUOTE
By: Scott Gottlieb, M.D.

FDA is committed to expanding access to safe and effective treatment options for patients with rare, debilitating, and sometimes fatal diseases. These patients face unique medical challenges. Sometimes there isn’t an FDA-approved drug to adequately address the needs of a patient with a rare disease. Therefore, the agency needs to take new steps to enable more patients with unmet needs to get access to promising treatments prior to full FDA approval.Two examples of the recent steps FDA has taken in pursuit of these goals are improvements we made to our Expanded Access Program and our Orphan Drug Program. These programs are high priorities of mine. They address the needs of patients with some of the most challenging conditions. Making sure there’s a close relationship with the efforts we take to expand pre-approval access to promising treatments, and the work of our orphan drugs program, is a key step toward maximizing opportunities for patients. To further achieve these goals, we’re announcing that FDA is widening the scope of the new Expanded Access Navigator tool, a comprehensive online information resource maintained by the nonprofit Reagan-Udall Foundation to facilitate pre-approval access to drugs. Previously this tool was rolled out for drugs that treat cancer. It will now apply to drugs that treat orphan diseases.

As I discussed in my testimony at a recent hearing of the Energy and Commerce Committee, expanded access programs play an important role for terminal patients who don’t have access to conventional, FDA-approved treatments. Because many orphan diseases don’t have FDA-approved treatment options, patients with a rare disease can benefit from early access programs.

There are numerous challenges to developing treatments for patients with rare diseases. For example, it can be hard to recruit clinical trial participants because of the small patient populations. In addition, there’s no single, consolidated place for patients with rare diseases to find companies that offer drugs on an expanded access basis, and then submit the information to enroll in these opportunities. This leaves a large, unmet need for access to investigational therapies among critically ill patients with rare diseases. Many of the innovative developers of orphan drug products are small companies that may face their own obstacles making this information available. We believe that patients shouldn’t face obstacles finding out which companies offer drugs on an expanded access basis, and then face additional unnecessary hurdles in accessing these programs.

Widening the scope of the Navigator program will help maximize the opportunity for patients to get access to promising treatments through clinical trials when these treatments are otherwise unavailable, and will advance the development of new drugs in a more transparent, accessible, and straightforward manner.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration
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CUV88
Posted on: Oct 27 2017, 10:56 PM


Group: Member
Posts: 187

I agree it seems like the NDA is submitted. Now the FDA is reviewing the application (2 months) . So if we are lucky in the year of printing which is 2017, we should get a decision around december yes or no for Priority Review -> If yes: Approval around July 2018 possible? Or do you interpret it differently?
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CUV88
Posted on: Oct 25 2017, 02:02 AM


Group: Member
Posts: 187

I would suggest everthing above 6m receipts is good. But since PW thought its worth mentioning twice in his last newsletter, i would expect double digit. Realistic CUV buffer maybe 8m
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CUV88
Posted on: Sep 28 2017, 12:17 AM


Group: Member
Posts: 187

Even if that is true and the share price is kept down for accumulation, the positive point is that those guys want to sell with a huge profit at some point. So in this scenario there will be a good uptrend in future, also good for us no?
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CUV88
Posted on: Sep 19 2017, 09:59 AM


Group: Member
Posts: 187

Soo, the data is available only in december thus NDA submission most likely Jan-Feb 2018? Plus 2 months verification and 6 months review. Now it seems be earliest approval october 2018

Also i dont like the idea of implementing the european PASS system in the US->First american implant 2019?
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CUV88
Posted on: Sep 9 2017, 07:14 AM


Group: Member
Posts: 187

As a redhead myself, i have to confess that my investment in this company was full of hope to benefit from afamelanotide someday. I am sure there alot of others who would be in need. This is also why a partnership with big pharma is fine for me, just get this damn product on the market so we all can use it!!!
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CUV88
Posted on: Aug 24 2017, 11:43 PM


Group: Member
Posts: 187

https://translate.googleusercontent.com/tra...646skeYxrnwiYFQ

QUOTE
No light sickness during pregnancy

Lisa Gudzenties already told the sad story about her illness five years ago ("It's as if I'm burning inside."). At that time, she struggled that her health insurance company take over the cost of UV protective clothing and travel expenses to doctors.

Meanwhile she has changed the health insurance with the help of RTL lawyer Christopher Posch. The new even takes the cost of the expensive drug Scenesse (a synthetic tanning hormone), which is used in Switzerland as an implant - albeit only four times a year. Actually, Lisa Gudzenties would need an implant every six weeks to be able to stay outside in the open during the day. But in this way it comes at least over the bright summer.

In the case of a human geneticist, she has had to check whether her children are also suffering from EPP before pregnancy. The result has taken her with relief: "They will only be carriers." That is, they may pass the disease further. By the way, during her pregnancy Lisa Gudzenties is almost free of complaints. "The babies are the stuff I'm missing. But as soon as they are born, it starts again. Probably even worse than before. "
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CUV88
Posted on: Aug 18 2017, 09:08 AM


Group: Member
Posts: 187

We all know this story very well ...retro offered either 0.175 Retrophin shares for each Clinuvel share, which was equivalent to $2.14 a share, or $2.17 in cash per share. If my calculation is right, i would have lost at least 10% with retro share exchange as of now and more than 50% with cash deal... the only one with a profit would have been martin and co
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CUV88
Posted on: Aug 18 2017, 08:40 AM


Group: Member
Posts: 187

Oh thanks for the info, Nvidia and i robot performed awesome as well... also if you bought bitcoin for 100$ Seven years ago you would be sitting at 75m$ Right now. Whats your point and whats your connection to retro?
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CUV88
Posted on: Aug 12 2017, 09:04 AM


Group: Member
Posts: 187

Good idea iggy, i bet you would get lots of those "no thanks" feedback. So do you work for lagoda, martin or another party that wants to keep CUV price down?
  Forum: By Share Code

CUV88
Posted on: Aug 5 2017, 05:21 AM


Group: Member
Posts: 187

Shkreli faces up to 20 years in prison for the 3 convictions.
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CUV88
Posted on: Aug 4 2017, 08:46 PM


Group: Member
Posts: 187

I dont think dividend makes sense at all right now. Every penny needs to be reinvested into FDA process and R&D for topical solution that can be sold to everybody. Dividends are for establised companys and not start ups in a growth mode with lots of momentum
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CUV88
Posted on: Aug 3 2017, 05:04 PM


Group: Member
Posts: 187

"Market Bell Ceremonies at the Nasdaq MarketSite in New York’s Times Square serves as a platform to generate exposure for your company, make a news announcement or celebrate corporate milestones. Hosted by a Nasdaq senior executive, the Opening and Closing Bells allow listed companies to address a wide audience with specific messages. Choreographed by a professional event planner, each ceremony is carefully designed to showcase your company on the Nasdaq Webcam, MarketSite Tower and participating television networks such as CNBC, Bloomberg TV, Fox Business News and many others - reaching millions of viewers worldwide."

I hope PW is ready for some PR show!
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CUV88
Posted on: Aug 2 2017, 04:19 PM


Group: Member
Posts: 187

As a friend of Martin you should be used to even higher prices
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CUV88
Posted on: Jul 31 2017, 05:00 PM


Group: Member
Posts: 187

With everything going under radar we might have at some point more cash on bank than market cap...

Btw i am also satisfied with this quarter. Hope we keep up this direction
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CUV88
Posted on: Jul 28 2017, 10:44 PM


Group: Member
Posts: 187

Thanks, i know this file, too. I meant how long in months... i would guess average is about 6 months plus minus 2 months? Or how long can this take at max, years!?

We should be very close already
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CUV88
Posted on: Jul 28 2017, 08:50 PM


Group: Member
Posts: 187

Does anybody know how long a rolling review within the fast track designation takes on average until the NDA is submitted to the FDA? Any experience or statistical links?
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CUV88
Posted on: Jul 26 2017, 11:57 PM


Group: Member
Posts: 187

So born in 1976? I always wanted to retire in my twenties with CUV cash out... this really looks unrealistic now after ten years of waiting
  Forum: By Share Code

CUV88
Posted on: Jul 20 2017, 05:20 AM


Group: Member
Posts: 187

If you are clever you can realize that im not him. Also i dont do multiple accounts yet
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CUV88
Posted on: Jul 20 2017, 03:17 AM


Group: Member
Posts: 187

Q: Scenesse has orphan and fast-track status for the EPP indication in the US, where in July last year the Food and Drug Administration said it would allow Clinuvel to file a rolling New Drug Application for the product. (Also see "PIPELINE WATCH: 13 Approvals, Two Filings And Two Launches" - Pink Sheet, 10 Jul, 2016.)
With regard to the rolling dossier, you’ve said in the past that you hoped to submit the first part in the first half of 2017.

L. Hay: "That’s perhaps optimistic but ... we like to be aggressive in our targets. Certainly by the end of this year."

There is no exact 6 month delay.... he said it might take longer. So definitely by the end of the year. MAX 6 month, hopefully less
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CUV88
Posted on: Jul 17 2017, 06:23 PM


Group: Member
Posts: 187

Oh whow! And its called "Chivére". Any idea what it could mean? Deja vu here we go. Where have you been the last week contro!? :D
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CUV88
Posted on: Jul 16 2017, 07:44 AM


Group: Member
Posts: 187

Clinuvels Pilot Program with patient involvement at the EMA seems to be very succeful:

http://www.ema.europa.eu/docs/en_GB/docume...WC500230985.pdf
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CUV88
Posted on: Jul 16 2017, 04:24 AM


Group: Member
Posts: 187

Its not too late guys, you still can sell your CUV shares and buy another stock with better performance. There is always a good investment somewhere out there
  Forum: By Share Code

CUV88
Posted on: Jul 15 2017, 05:07 AM


Group: Member
Posts: 187

Welcome Desert Rat, good first post. Thanks for the info
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CUV88
Posted on: Jul 14 2017, 08:04 PM


Group: Member
Posts: 187

Carte Blanche = iggy ...
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CUV88
Posted on: Jul 12 2017, 02:19 PM


Group: Member
Posts: 187

They also reserved some domains for it:

chivere.asia 2017-02-09
chivere.biz 2017-02-09
chivere.info 2017-02-09
chivere.mobi 2017-02-09
chivere.net 2017-02-09
chivere.org.uk 2017-02-09
chivere.org 2017-02-09
chivere.us 2017-02-16

Also new ones:

clinuvel.at 2017-07-11
clinuvel.co.at 2017-07-11

vallaurix.co.uk 2017-02-09

http://viewdns.info/reversewhois/?q=Clinuvel
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CUV88
Posted on: Jul 12 2017, 08:35 AM


Group: Member
Posts: 187

QUOTE
Skin care preparations; cosmetic preparations for skin care; cosmetic preparations for skin care, based on analogues of melanocyte stimulating hormone (MSH),in particular afamelanotide...


It says analogues. As soon afamelanotid is approved by the FDA, isnt it possible an analogue has a good chance to be placed without further trials?
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CUV88
Posted on: Jul 11 2017, 10:53 PM


Group: Member
Posts: 187

Way to go! Seems one patient more online
  Forum: By Share Code

CUV88
Posted on: Jul 11 2017, 05:08 AM


Group: Member
Posts: 187

Why so annoyed today? SP too high?
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CUV88
Posted on: Jul 11 2017, 05:01 AM


Group: Member
Posts: 187

At least sharelooker seems to be a smart guy ( probably Phd or higher?) ... check post history
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CUV88
Posted on: Jul 11 2017, 03:30 AM


Group: Member
Posts: 187

Drop in (european) Winter Sales is going to be less of a problem when the US, Australia and ROW are online. So again FDA is the bottle neck

BTW: I think this interview of lachlan is pretty old already
  Forum: By Share Code

CUV88
Posted on: Jul 11 2017, 02:53 AM


Group: Member
Posts: 187

"Shares of Clinuvel Pharmaceuticals Ltd (CLVLY) are on watch as the Tenkan Line has moved above the Kijun line, indicating positive momentum for the equity. Clinuvel Pharmaceuticals Ltd moved 0.00 in the most recent session and touched 5.0700 on a recent tick."

...love those sites...

http://aikenadvocate.com/chartists-taking-...-shares/260845/
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CUV88
Posted on: Jul 7 2017, 11:20 PM


Group: Member
Posts: 187

Dear Dr. Wolgen,

How much additional cash do we have to throw into the bucket, to accelerate the overall process of Scenesse and topicals OTC, Platform for others?
I know FDA is taking full attention, but the global Clinuvel 2020 strategy has to work on multiple products NOW.

After FDA we need to preasure PR for those products and find a partner ASAP?

Bi Monthly news please!
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CUV88
Posted on: Jul 7 2017, 07:32 AM


Group: Member
Posts: 187

I guess its the rampers. Also there is no helping drug Scenesse for EPP since there are no such patients. There is no global warming and we have never been on the moon...
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CUV88
Posted on: Jul 1 2017, 08:47 AM


Group: Member
Posts: 187

In FB Clinuvel Photoprotection group somebody posted in swedish following:

QUOTE
I actually heard that there is Scenesse now in the hospital here in Örebro. I've got a referral there. I can hear from me as soon as I know more.


Maybe we have a foot in the door in sweden!
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CUV88
Posted on: Jun 30 2017, 03:21 AM


Group: Member
Posts: 187

https://www.fda.gov/downloads/ForIndustry/D...n/UCM565068.pdf
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CUV88
Posted on: Jun 28 2017, 12:07 AM


Group: Member
Posts: 187

Sure, this year was so much content expected to introduce a bimonthly newsletter. I wonder if the third newsletter this year will be on time, if thats still possible. But hey only one announcement would be enough for me in 2017: FDA Approval
  Forum: By Share Code

CUV88
Posted on: Jun 27 2017, 10:45 PM


Group: Member
Posts: 187

What do you expect? Quarterly is announced at the end of july...FDA news?
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CUV88
Posted on: Jun 27 2017, 07:48 AM


Group: Member
Posts: 187

Yes i think they might approve up to 4 implants.

But this is an agreement for only one expert center and not on a national level.

"In Italy some regions have already moved to purchase Scenesse, and several reference centers, including Modena, Milan, Trieste, Brescia, Rome and Padua, have been accredited for the administration.
Every region lives a different and particular reality, some do not have the funds to repay the drug, in others there is no expert center to administer it.

The patient association has called for a meeting at the Ministry of Health to promote the delivery of SCENESSE unanimously at national level."

Source:
https://www.osservatoriomalattierare.it/por...di-appartenenza
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CUV88
Posted on: Jun 27 2017, 07:05 AM


Group: Member
Posts: 187

If it speeds up the rollout of SCENESSE the EPP Centers may have these 2% of sales smile.gif
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CUV88
Posted on: Jun 27 2017, 06:36 AM


Group: Member
Posts: 187

Tried to put it into online translate:

"Attached to the contract for the commercial supply of SCENESSE to patients who have been diagnosed and according to the protocol of treatment

Activities that do not fall within the normal scope of clinical practice (collection of safety and efficacy data and entry into the register)

CLINUVEL (UK) LTD and the holder of a marketing authorization for SCENESSE is a newly licensed photoprotective drug for sale by the European Agency for Medicines in Exceptional Circumstances for the Treatment of EPP Disease.

The European Medicines Agency requires CLINUVEL to collect post-authorization safety data and long-term efficacy data and the clinical benefits of SCENESSE in patients with EPP.

Consequently, CLINUVEL can provide SCENESSE for commercial purposes only to institutes that agree to attend CLINUVEL and in accordance with a protocol supervised by the Competent Authorities. The Institute is experienced in providing routine care to patients diagnosed with the EPP and wants to receive SCENESSE commercial supplies.

CLINUVEL (UK) Ltd agrees to pay SC Dermatology U C / o AOU City of Health and Science of Turin for the collection of safety and efficacy data required to comply with regulatory requirements in a post-authorization study, As they do not fall within the normal scope of clinical practice. The sponsor therefore, for these activities, amounts to € 1606.25 for patients undergoing treatment. The compensation is a fixed amount and covers the specific study procedures provided by the Institute's staff in compliance with the requirements of the SCENESSE Commercial Supply Contract for patients who have been diagnosed with the EPP under the Treatment Protocol dated March 2016 Including Appendices to the Contract."

Screening 196.75 €
Implant 1 (includes photographic and dermatological evaluation) € 434.25
Day 60 Implant 2 - 270,50 €
Day 120 Implant 3 - 270,50 €
Day 180 Implant 4 - (includes photo and dermatological evaluation) - 434.24 €
Total 1606,25 €
  Forum: By Share Code

CUV88
Posted on: Jun 19 2017, 04:54 PM


Group: Member
Posts: 187

In the progress overview it still says 21. June

http://www.awmsg.org/awmsgonline/app/appraisalinfo/634
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CUV88
Posted on: Jun 15 2017, 12:06 AM


Group: Member
Posts: 187

I am quite sure the Formulation of the Topical Solution from Clinuvel is already in PW's drawer. Just kept Secret until FDA Approval, to be on the safe site. Why? Because the authorities just dont like tanning cremes. Also my personal feeling is, vallaurix was created because the EMA would only grant approval if Clinuvel would not sell cosmetic/topical products in the furure.
  Forum: By Share Code

CUV88
Posted on: Jun 8 2017, 02:27 AM


Group: Member
Posts: 187

We have a Provisional Schedule for the HST now:

Committee meeting: 1 17 October 2017
Committee meeting: 2 20 February 2018
Expected publication May 2018

https://www.nice.org.uk/guidance/indevelopment/gid-hst10009
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CUV88
Posted on: Jun 7 2017, 09:41 AM


Group: Member
Posts: 187

“There will be one price and no discounts, no backroom deals, no incentives off the record.” In an interview with the Pink Sheet, Clinuvel UK’s general manager Lachlan Hay talked about the company’s unusual pricing policy for its equally unusual photoprotective therapy, Scenesse (afamelanotide), its frustrations at out-of-sync regulatory and market access systems, and how its plans for a US regulatory filing are going."

https://pink.pharmamedtechbi.com/PS120803/I...oes-The-Unusual

Does somebody habe full access? Thanks.
  Forum: By Share Code

CUV88
Posted on: Jun 1 2017, 02:57 AM


Group: Member
Posts: 187

Do you think NDA will happen in H1, so next 4 Weeks?
  Forum: By Share Code

CUV88
Posted on: May 31 2017, 12:51 AM


Group: Member
Posts: 187

Who will pay that drug now too expensive?
Two appeals to the Federal Court do not end the dispute between a woman living in Ticino suffering from a serious skin disease and her insurance - Causing the escalation of the price of the only medication available

BERNA - Two appeals to the Federal Court were not enough to put an end to the question of who would pay the drug Scene to a woman living in Ticino suffering from a rare skin disease - erythropoic protoporphyria (EPP) - that causes burns , Erythema and edema in sunny areas.

The underlying problem is the dizzying increase in the cost of the drug decided by the company, Clinuvel Pharmaceutical, in 2015. A drug that is apparently the only one on the market that can successfully deal with the disease the woman suffers. In fact, between 2012 and 2015, CSS (old woman insurance) repaid her 6,560 francs per dose, which would take 4 to 5 times a year. Then, the price increase. Now a dose costs 18,989 francs (24,772 will be from 2019), three times as much. CSS informed the woman that she would not change her refund, and from November 2016 she would have dropped her 20%; Decision also maintained by Intras to change the health insurance.

On September 21, 2016, the Cantonal Cantonal Court of Canton Ticino gave reason to the woman and sentenced Intras to fully cover the costs of the drug, but both of them applied to the Federal Court: the woman because the cover was for four doses, while the doctor Who had taken care of her had prescribed five; The insurance because it wanted the annulment of the decision.

The Federal Court, in its decision of May 9, made known today, however, sent the wrapper to the cantonal court to re-establish the procedure on new bases. While on the one hand he felt in principle that the cost-benefit ratio of the drug was balanced despite price increases, the other complained that the patient's health status reports from the underlying doctor Too succinct and not sufficient to determine the positive impact of the drug in the woman's life (the doctor said that before the doses of Scene the patient was forced to live in the dark, and that by the medication he could even undertake a work ). Mon Repos's judges have also challenged the five annual doses prescribed by the doctor when the medication dosage (which in Switzerland is not approved by Swissmedic but is in Europe) states that four of them are worth it.

It will therefore be up to the Cantonal Court to order a new medical examination to give more light to the woman's health, and then to arrive at a new ruling. In the meantime, both parties will have to pay 500 francs for legal expenses and Intras 2,800 for the woman as repeatable.
  Forum: By Share Code

CUV88
Posted on: May 29 2017, 05:48 AM


Group: Member
Posts: 187

Validation period and filing period is in my opinion the same only different wording: in those two month the FDA checks if the NDA is complete and if priority review is granted.
  Forum: By Share Code

CUV88
Posted on: May 28 2017, 10:11 PM


Group: Member
Posts: 187

I still had trouble understanding where we are right now in the FDA process and when a possible approval might be realistic. So i did some research and want to share my insights:

FDA NDA

„Once a company reaches the NDA stage, the probability of the drug receiving FDA approval and being marketed in the U.S. exceeds 80%. Filing of an NDA typically does not result in a substantial increase in the share price of the sponsor company, as most of the stock appreciation is likely to have occurred as the investigational drug progressed through successive phases of earlier clinical trials.“[1]

„The final FDA decision to approve or not approve a new product occurs on the Prescription Drug User Fee Act (PDUFA) meeting date. The PDUFA date is the final step in the formal regulatory pathway.
Trial data, AdCom panel votes and PDUFAs make smaller company shares move dramatically.“[2] 

Timeline

„In 2008, the Office for Orphan Products oft he FDA awarded SCENESSE orphan designation for EPP. Significant advantages of the orphan designation include substantially lower NDA filing fees and market exclusivity for seven years following first market access in the US.“ [3]

July, 2016: „… US Food and Drug Administration (FDA) has granted SCENESSE (afamelanotide 16 mg) Fast Track designation for the treatment of erythropoietic protoporphyria (EPP). [3]

„Clinuvel will submit the modular dossier on SCENESSE on a rolling basis during the first half of 2017. After the completion of the submission of the dossier the FDA will observe a validation period of two month. Further interactions between DDDP and CLINUVEL will take place as the submission progresses.“ [4]

In my understanding: After the NDA has been submitted by Clinuvel there are two possibilities:

Priority Review: 60-day filing period plus 6-month review = 8 months from receipt date to PDUFA date
Standard Review: 60-day filing period plus 10-month review = 12 months from receipt date to PDUFA date

Sponsors need to request Priority Review with the submission of their NDA. Fast Track designation increases the likelihood that a product will be granted Priority Review. This, however, is not guaranteed, and the Sponsor must still apply for the designation. FDA responds to the request within 60 calendar days of the date of NDA submission.
In 2014, 25 of the 41 novel drugs approved were granted Priority Review. Similarly, in 2015, 24 of the 45 novel drugs approved were granted Priority Review. [6]

In my opinion, if Clinuvel submits its NDA at the end of June we will probably need another 8 month with a possible PDUFA around February 2018 only when we get Priority Review.
With the standard review it might be July 2018.

Sorry if I pickup on this again. Is my understanding right?

Source:

[1]http://www.investopedia.com/terms/n/new-drug-application-nda.asp#ixzz4hhKZODz2 

[2]https://www.streetwisereports.com/pub/na/pdufa-whats-a-pdufa-understanding-the-drug-development-process-is-key-to-biotech-investing

[3] CUV ASX Announcement 06/07/2016 - FDA awards SCENESSE Fast Track designation for EPP treatment
http://www.asx.com.au/asx/statistics/displ...;idsId=01755123

[4] CUV ASX Announcement 09/11/2016 - CLINUVEL agrees with FDA on New Drug Application timelines
http://www.asx.com.au/asx/statistics/displ...;idsId=01800197

[5] CUV ASX Announcement 20/01/2016 - CEO Brief
http://www.asx.com.au/asxpdf/20160120/pdf/434gx4vkch4vgg.pdf

[6] http://3dcommunications.us/insight/cder-expedited-pathways/
  Forum: By Share Code

CUV88
Posted on: May 3 2017, 01:32 AM


Group: Member
Posts: 187

Thanks for clarification. Isnt accelerated approval also an option, as shortest way for approval?
  Forum: By Share Code

CUV88
Posted on: Apr 20 2017, 03:30 PM


Group: Member
Posts: 187

No, i am using a cellphone with touchscreen. Sometimes i get on like buttons when im scrolling the page. Theres also no unlike button
  Forum: By Share Code

CUV88
Posted on: Apr 20 2017, 08:30 AM


Group: Member
Posts: 187

Everybody is welcome to post everything RELATED to this discussion. I can ignore those false posts BUT people who are not familiar with details are easily flooded with offtopic stories containing lies that are obviously used to manipulate. You for example are a new member with no post that actually contains CUV related information. The only thing we see is that you support ignoramus who we try to get rid of. If your intention is the same you are No. 2 who has to leave
  Forum: By Share Code

CUV88
Posted on: Apr 19 2017, 11:41 PM


Group: Member
Posts: 187

I asked the sharescene admin to remove ignoramus from this discussion. Everybody who feels the same way, please show your support. Its enough lies, and im sick of it. And since this is a public forum other people deserve true information and a chance to join a fair board
  Forum: By Share Code

CUV88
Posted on: Apr 19 2017, 11:21 PM


Group: Member
Posts: 187

Thank you for sharing your path to CUV. Your comments are partitally entertaining, but some statements are just not true and misleading. And i think people might be confused, so please just stop posting on this board and leave since you dont have any CUV shares anyway.
  Forum: By Share Code

CUV88
Posted on: Apr 19 2017, 11:12 PM


Group: Member
Posts: 187

Hello fresher, you are very new to this board and sympathize with ignoramus, who in your opinion is "generous" contributing very questionable statements. So why is that, wouldnt you first try to read alittle through the comments before judging anybody who is longer on this board than you? - sorry guys this is getting more fun every day coming closer to FDA decision
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CUV88
Posted on: Apr 19 2017, 05:05 PM


Group: Member
Posts: 187

So whats your deal then for trolling here? You appeared shortly before take over bid by Retrophin. First i thought you might be Mr. Shkreli himself, but i really think he has better things to do. But maybe you work for him? Hes probably not happy how things went with this company
  Forum: By Share Code

CUV88
Posted on: Apr 11 2017, 03:27 PM


Group: Member
Posts: 187

This doesnt make any sense. Even if the price was discounted yesterday, the numbers for the quarter were fix already end of march
  Forum: By Share Code

CUV88
Posted on: Apr 10 2017, 10:39 PM


Group: Member
Posts: 187

This is indeed fantastic news! So rollout in europe is safe!! Germany ur9 is up 6%
  Forum: By Share Code

CUV88
Posted on: Apr 8 2017, 01:00 AM


Group: Member
Posts: 187

I am also expecting 7m AUD
  Forum: By Share Code

CUV88
Posted on: Mar 10 2017, 09:24 AM


Group: Member
Posts: 187

http://www.marketindex.com.au/sites/defaul...lance-march.pdf

So CUV didnt make it into ASX300, pity
  Forum: By Share Code

CUV88
Posted on: Mar 1 2017, 09:53 AM


Group: Member
Posts: 187

" I’m still hanging in there with the vague thought that an opportunity may someday arrive that Clinuvel will be a worthwhile investment."

- Could you elaborate please?
  Forum: By Share Code

CUV88
Posted on: Mar 1 2017, 08:46 AM


Group: Member
Posts: 187

Good morning iggy! Your Assumptions are one of af kind. No Links, no quotes just some shitty thoughts of yours. As clever as you are and as much i appreciate some contrary thoughts and intelligent input, i still dont know why you spend so much time on this board if you are not invested or interested in this stock. Still you try to provide some misleading information?

Oh yeah wait: since when are you on board? Shortly before october 2014 when retro offered to take over clinuvel.
  Forum: By Share Code

CUV88
Posted on: Feb 28 2017, 06:48 PM


Group: Member
Posts: 187

I wonder what this QR9 is you keep talking about ...
  Forum: By Share Code

CUV88
Posted on: Feb 28 2017, 05:44 PM


Group: Member
Posts: 187

yes indeed, iggy. Everbody is buying and selling shares on basis of your posts here. This bullish post of yours also influenced Dow Jones to an all time high
  Forum: By Share Code

CUV88
Posted on: Feb 27 2017, 10:50 PM


Group: Member
Posts: 187

These are comments out of the current petition for germany, just read them and you know its not only about share price movement but about patients demand and proof of benefit.

1. I have EPP too and have been prescribed scenesse a few times now. It charged my life. The german patients deserve it too!!
2. I am an EPP patient and I have used Afamelanotide with success.
3. I ' am Signing because I know how much we EPP patients benefit from this medicine. I can live a normal life since The Netherlands has accepted This.
4. I'm a patient myself en afamelanotide/Scenesse really helps!! it is a life changer.
5. I have EPP my self and I'm very thankfull that I can use Scenesse. It should be available fot every one who need it.
6. My life for my WHOLE family and myself changed 500% ! Now I am able to run a normal life ! Can't live without it! All patients dezerve this medicine.
7. I sn sining because i Also have e.p.p. And jusing scenesse
8. Scenesse helps!! After 30 yeras waiting for a medicine, i experienced substantial better protection against the sun, i'm having an normal life after many years! Germany, please put EPP and Scenesse on the medical political agenda!
9. I have epp myself and now the importance of scenesse
10. I have EPP and know from own experience how this influences my life and how scenesse can help.
11. Because I got a lot of profit out of the Afemelanotid therapy myself.
12. I am a patient too en this medicin is very much needed!
13. My husband suffers from EPP. This medicine makes a huge difference.

Look how much it already helps people, i am very satisfied to be part of this!
  Forum: By Share Code

CUV88
Posted on: Feb 24 2017, 05:09 PM


Group: Member
Posts: 187

Vallaurix Pte Ltd

Vallaurix is a subsidiary of Clinuvel Pharmaceuticals headquatered in Melbourne, Australia.

Clinuvel is a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.

Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe. In December 2014 the European Commission granted SCENESSE® marketing authorisation under exceptional circumstances for the prevention of phototoxicity in adult patients with EPP. Further trials of SCENESSE® are underway in the pigmentary disorder vitiligo.

Office Manager

- Interesting and diverse role in a growing international organization

- Important support to executives and all staff

- Requires well developed organizational skills



Vallaurix Pte Ltd is a Global Pharmaceutical company with an opening for an Office Manager. The company seeks an enthusiastic individual with proven experience in office and business administration to manage its Singapore office facilities and also to provide key administrative support to the finance and Lab development teams.



The role will requires a flexible, intelligent and personable individual who is able to work on a number of activities at one time, both independently and with key staff. An office manager is vital in a growing organization and problem solving skills are essential.



You will be the first point of call for all incoming office communications and be responsible for the management of all general office tasks (supplies, daily routine, IT issues) and telecommunications, requiring you to build relationships with essential stakeholders. You will be responsible for organizing meeting calendars, monitor management schedules, providing ad hoc assistance to the team are other important duties you will be required to perform.



The role will also require you to manage and oversee creation of filing systems and setting up supplier accounts as well as manage the payroll, accounts payable and associated banking functions.



Candidates must demonstrate the following personal qualities and experience:

- Previous history working in a similar role

- Adaptable in constantly changing environment

- Ability to prioritise work, to problem solve and to display initiative where needed

- Ability to learn an organizational structure and manage internal and external relationships

- Computer literate

- Very good written and verbal communication skills in English and German (native speaker of one and fluent in the other preferred)

- A bright, enthusiastic, motivated, professional manner



This is a full time role with some overtime required for specific projects or busy periods.

http://sg.jobsdb.com/sg/en/job/office-mana...400003003126252
  Forum: By Share Code

CUV88
Posted on: Feb 18 2017, 12:25 AM


Group: Member
Posts: 187

Contro, thank you for trying to keep this forum in a good balance. Nevertheless, could you please concentrate on Posting only "News" and not repeating everything over and over again. You dont need to comment every little move in SP and try to explain why it moves, we are all grown up people here. Also for new people this is not giving a professional feeling. What we need is facts, links, quotes and everything most recent please. You already had some good posts like that. Hope this helps.
  Forum: By Share Code

CUV88
Posted on: Feb 17 2017, 03:11 AM


Group: Member
Posts: 187

The Market Cap. is probably good enough for asx300 but i think CUV liquidity might be a problem, if we are lucky the last weeks of increased volume pushed us in.
  Forum: By Share Code

CUV88
Posted on: Feb 17 2017, 03:03 AM


Group: Member
Posts: 187

When do rebalances occur?
• After the market closes on the third Friday of March, June, September and December.



How much notice is given?
• The market is notified one to two weeks prior to all upcoming constituent changes.

March, June & December - one week notice is given

September - two weeks notice is given

Note: Starting March 2016, only one week notice will be given for Quarterly Rebalances in March, June and December. September will keep the two week notice period.

http://www.marketindex.com.au/rebalance-announcements

  Forum: By Share Code

CUV88
Posted on: Feb 16 2017, 01:17 PM


Group: Member
Posts: 187

epp.care
  Forum: By Share Code

CUV88
Posted on: Feb 13 2017, 07:21 PM


Group: Member
Posts: 187

You are so full of shit. People fly from America to Europe to get Scenesse. And i guess they would not do it if it wasnt worth it, nomatter what studpid P Values say. We got EPP patients in Europe AND the US that demand this treatment. If your proposed treatment is so great why wouldt you fly over to the US and just get it!?
  Forum: By Share Code

CUV88
Posted on: Jan 25 2017, 05:23 AM


Group: Member
Posts: 187

The only one posting there is you sante....
  Forum: By Share Code

CUV88
Posted on: Jan 8 2017, 11:11 PM


Group: Member
Posts: 187

Here on this board was lots of dreaming in the last years. But this year its different....
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CUV88
Posted on: Dec 28 2016, 12:52 AM


Group: Member
Posts: 187

http://www.theaustralian.com.au/business/c...0afaefbadb0eb67

"The Australian technology is already helping patients and 12 US families are travelling to Switzerland every month to ­obtain the treatment."

“We are not interested ... we are building the value ourselves, ­distributing ourselves. No one wanted to know us before, now there is interest,” Dr Wolgen said.
  Forum: By Share Code

CUV88
Posted on: Dec 10 2016, 01:50 PM


Group: Member
Posts: 187

"We found that the compound outperformed reference compound NDP-MSH, afamelanotide, by achieving highest efficacy (227% at 10"8 M vs 156% at 10"9 M; with the compound actually also having a higher efficacy of 198% at 10"9 M) and the results were statistically different compared to the control (at p <0.05) at concentrations from 10"10 M to 10"7M."
  Forum: By Share Code

CUV88
Posted on: Nov 27 2016, 08:48 AM


Group: Member
Posts: 187

The quality of posts is obviously lacking. But there is something beautiful about pure quantity. This Clinuvel discussion is No.1 in the amount of views and No.2 in replies on sharescene. Every post is pushing us up in search engine ranking, increasing visibility online. We have patients on twitter, who demand SCENESSE in the US. There are Facebook groups discussing this miraculous treatment. Soon there are going to be storys about life changing SCENESSE all over social media. That is probably how Sean Parker found this investment, and this is the way how much more people will find this investment.

So let everybody post as much as they want, what ever they want. There is no such thing as bad publicity.
  Forum: By Share Code

CUV88
Posted on: Nov 24 2016, 06:04 PM


Group: Member
Posts: 187

Rebalances are conducted biannually in March and September.
  Forum: By Share Code

CUV88
Posted on: Nov 22 2016, 04:19 PM


Group: Member
Posts: 187

"Quick Technology Assessment conducted for afamelanotide (Scenesse) to treat patients with erythropoietic protoporphyria (EPP) by the Norwegian Medicines Agency."

This decision was made on 13. June 2016. Translated from

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

Definition:

"Quick method reviews

A rapid technology assessment is a summary of knowledge focusing on efficacy, safety and cost effectiveness.
Quick Technology Assessment on drugs carried out by the Norwegian Medicines Agency, while Public Health performs rapid method reviews on methods that are not drugs.

By rapid technology assessment is preferably the manufacturer / supplier who retrieve documentation and prepares necessary analyzes. Studying Instance conducts then the method evaluation within a deadline of 180 days from the date of documentation received."

Source: https://nyemetoder.no/om-systemet/metodevurderinger

I hope to see another update in december, maybe alittle christmas present for us wink.gif
  Forum: By Share Code

CUV88
Posted on: Nov 20 2016, 02:58 AM


Group: Member
Posts: 187

Hopefully they will upgrade now, with sales growing in europe. I would love to see a tesla charged by solar panels. Perfect for a company thats an expert in sun and light...
  Forum: By Share Code

CUV88
Posted on: Nov 17 2016, 05:23 PM


Group: Member
Posts: 187

So as of now, no employees of the FDA are allowed to purchase Clinuvel stock for ethical reasons. Some kind of process must have started
  Forum: By Share Code

CUV88
Posted on: Nov 17 2016, 03:11 PM


Group: Member
Posts: 187

Clinuvel on Listing of Significantly Regulated Organizations (SRO)

Which companies are included on the SRO List?

A publicly traded company, US or foreign stock exchange, is added to the SRO List if it meets either of the following criteria:
It is an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year;
An organization that does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA.

http://www.fda.gov/aboutfda/workingatfda/e...s/ucm079670.htm

  Forum: By Share Code

CUV88
Posted on: Oct 25 2016, 04:35 PM


Group: Member
Posts: 187

"Currently on the FDA EPP web mtg. Seeing/hearing a great representation for those suffering with EPP. Thank you!..."

"I'm also attending the web meeting from South Africa. Thanks to all for their efforts. Gives us hope😊"

"Feeling grateful and positive. Thank you FDA."

You seem to only find negative posts
  Forum: By Share Code

CUV88
Posted on: Oct 9 2016, 03:18 AM


Group: Member
Posts: 187

8.51 AUD
  Forum: By Share Code

CUV88
Posted on: Sep 8 2016, 02:22 AM


Group: Member
Posts: 187

What kind of news do you have in mind? Numbers came last month*, fda meeting is in october, vitiligo probably no news...

News from germany would be nice, but nothing heard or seen. Maybe another country going live?
  Forum: By Share Code

CUV88
Posted on: Jul 6 2016, 12:27 PM


Group: Member
Posts: 187

FDA awards SCENESSE® Fast Track designation for treatment of EPP!!!

That is fantastic news, glad to see the patient groups indeed have an influence:

http://www.asx.com.au/asxpdf/20160706/pdf/438d04cjr2bg20.pdf


  Forum: By Share Code

CUV88
Posted on: Jun 24 2016, 07:08 PM


Group: Member
Posts: 187

The CHF is probably going to increase in Value, switzerland is a save place to be. I think you are right, this exit should not harm CUV income. Maybe its even better with a stronger CHF
  Forum: By Share Code

CUV88
Posted on: Jun 9 2016, 08:06 AM


Group: Member
Posts: 187

Yes. Yes. How is that? When? Why? Why? Yes.Yes.Yes.Yes.

WTF is your point????
  Forum: By Share Code

CUV88
Posted on: May 31 2016, 08:34 AM


Group: Member
Posts: 187

Seems like following might be the new info page:

http://epp.care

"EPP.Care is published by Clinuvel Pharmaceuticals to provide information and resources related to Erythropoietic Protoporphyria. Information presented on this site is presented for educational and informational purposes only and is not a substitute for professional medical and health advice. Please consult a relevant health care provider if you have any questions or concerns."
  Forum: By Share Code

CUV88
Posted on: May 14 2016, 01:31 AM


Group: Member
Posts: 187

Deadline was May 20th, but indeen 17th is probably going to be more interesting
  Forum: By Share Code

CUV88
Posted on: Jan 22 2016, 03:52 PM


Group: Member
Posts: 187

https://www.facebook.com/AccelerateApprovalOfAfamelanotide/

Please like and share! We should try to support the patient groups.
  Forum: By Share Code

CUV88
Posted on: Dec 21 2015, 01:20 AM


Group: Member
Posts: 187

"The federal charges partly parallel a lawsuit filed against Shkreli in August by Retrophin, whose board ousted Shkreli as chief executive in September 2014. At the time, Retrophin had launched a takeover offer for the ASX-listed Clinuvel Pharmaceutical, with Shkreli involved directly.

"He led the approach," one source close to Clinuvel said. Retrophin's bid for Clinuvel was well timed, coming only a matter of weeks before the Australian company won approval to launch its treatment, known as Scenesse which is a treatment for light sensitive people. It won approval to launch its treatment in Europe in October 2014.

A matter of months earlier, in July of that year, Shkreli's Retrophin offered its shares in return for Clinuvel shares held, or $2.17 in cash. At around the same time, Retrophin emerged with a 7.8 per cent stake in Clinuvel, having paid as much as $4.44 a share although the average price paid would have been significantly less.

Shkreli had already turned a seller of Clinuvel shares in the fortnight ahead of Clinuvel winning approval to enter the European market, but appears to have profited from the subsequent share price surge, selling the bulk of his holding at over $4 a share. At around the same time, Shkreli was pushed out of Retrophin.

In its lawsuit, Retrophin accused Shkreli of having used the company as a kind of personal piggy bank to help pay off upset investors who lost money at MSMB. Among the ways he did this, the lawsuit says, was by hiring some of these investors as sham consultants to Retrophin."

http://m.smh.com.au/business/world-busines...217-glqjrw.html

Seems like the australians think Shkreli was arrested because of clinuvel and his takeover game?

  Forum: By Share Code

CUV88
Posted on: Oct 8 2015, 12:35 AM


Group: Member
Posts: 187

Well yeah, we should cut some of PWs bonus. She is definitely doing more work and communicaton than him. Also i believe Desiree is the reason for approval in the EU with all the patient engagement.
  Forum: By Share Code

CUV88
Posted on: Sep 6 2015, 12:20 AM


Group: Member
Posts: 187

.
  Forum: By Share Code

CUV88
Posted on: Sep 5 2015, 08:32 PM


Group: Member
Posts: 187

I think people should be allowed to make an own decision to take or not take this drug based on the information we have now. People with EPP are already waiting for years. If they dont get it they might just take the illegal solution mela 1 or 2 like the bodybuilds and tan freaks. If i was in the authorities i would rather see it on the market under my control than all people injecting illegal solutions from the internet. JUST CANT UNDERSTAND THE AUTHORITIES
  Forum: By Share Code

CUV88
Posted on: Sep 5 2015, 07:39 PM


Group: Member
Posts: 187

In the big german Newspaper "BILD" an article about EPP and Scenesse was published yesterday:

http://www.bild.de/ratgeber/gesundheit/sel...95230.bild.html

Jasmin Barman-Aksözen: „Wir wissen jetzt – acht Monate nach der offiziellen Zulassung durch die EU – immer noch nicht, ob diese erste und einzig wirksame Therapie für EPP für die Patienten in Deutschland je verfügbar sein wird. Wir können nur spekulieren, welche Gründe die Verzögerung hat. Es ist sehr frustrierend. Zudem verzögert sich natürlich auch die Verfügbarkeit der Behandlung für die am schlimmste betroffene Gruppe – Kinder und Jugendliche – Studien können erst beginnen wenn das Medikament bei Erwachsenen eingesetzt wurde.“

Das zuständige Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) darf aus Datenschutzgründen keine genauen Details über die Zusammenarbeit mit dem Medikamentenhersteller nennen. BfArM-Sprecher Maik Pommer zu BILD: „Die schnelle Versorgung der Patientinnen und Patienten mit sicheren und wirksamen neuen Therapieoptionen hat für das BfArM höchste Priorität. Dies gilt in besonderem Maße für die EPP-Patienten, deren Versorgung gerade in den Sommermonaten von besonderer Bedeutung ist. Voraussetzung dafür ist eine schnelle und vollständige Einreichung von Unterlagen durch den Zulassungsinhaber (in diesem Fall der Hersteller).“

Ist ein neues Medikament zugelassen, bedeutet das nämlich nicht unbedingt, dass es ohne weiteres auf den Markt kommen kann. Bei Agamelanotid, bei dem die Sicherheit und Wirksamkeit noch nicht abschließend geklärt sind, muss zum Beispiel ein Krankheitsregister eingerichtet werden, um die Langzeit-Auswirkungen des neuartigen Medikaments auf die Patienten im Blick zu behalten, für die verabreichenden Ärzte muss es Informations- und Schulungsprogramme (z.B. Videos) geben. Ganz wichtig ist auch ein kontrolliertes Abgabesystem um Missbrauch zu verhindern, etwa, dass gesunde Menschen versuchen, Afamelanotid zu bekommen, um sonnenlos braun zu werden.
Für Menschen wie Clara oder Jasmin ist das Mittel einfach der lang ersehnte Weg aus ihrem Schattendasein.

Translation:

Jasmin Barman-Aksözen: still do not know whether this first and only effective treatment for EPP will ever be available to patients in Germany - "We now know - eight months after the official approval by the EU. We can only speculate what reasons has the delay. It's very frustrating. In addition, of course, delay the availability of treatment for affected the worst group - children and young people - studies can begin when the drug was used in adults only. "

The competent Federal Institute for Drugs and Medical Devices (BfArM) allowed for privacy mention any exact details about working with the drug manufacturers. BfArM spokesman Maik Pommer told BILD: "The rapid supply of patients with safe and effective new treatment options is a top priority for the BfArM. This is especially true for EPP patients whose care is just in the summer months are of particular importance. This requires a rapid and complete submission of documents by the marketing authorization holder (in this case the manufacturer). "

Is a new drug approved, that means namely not necessarily mean that it can reach the market without further notice. In Agamelanotid in which the safety and efficacy have not yet been fully clarified, must a be disease registries set up, for example, to retain the long-term effects of the new drug on the patient in mind, for the administered doctors it needs information and training programs (eg videos) give. Very important is also a controlled delivery system to prevent abuses, such that healthy people are trying to get Afamelanotide to be sunless brown.
For people like Clara or Jasmine, the agent is simply the long-awaited way out of the shadows.
  Forum: By Share Code

CUV88
Posted on: Aug 27 2015, 03:39 AM


Group: Member
Posts: 187

Official statement to the second twitter account
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CUV88
Posted on: Aug 20 2015, 02:32 AM


Group: Member
Posts: 187

Maybe lachlan forgot his PWD and had to create a new account tongue.gif
  Forum: By Share Code

CUV88
Posted on: Aug 20 2015, 02:26 AM


Group: Member
Posts: 187

Maybe PW gets a bonus from big pharma for every silent month and a double bonus for not holding timelines... So bored, sorry
  Forum: By Share Code

CUV88
Posted on: Jun 30 2015, 07:37 PM


Group: Member
Posts: 187

Wouldnt it be a good moment for a partnership after pricing is negotiated and distribution has to commence? I dont think clinuvel wants to distribute scenesse for epp all alone. For Vitiligo it is just not possible without partnership.
  Forum: By Share Code

CUV88
Posted on: May 22 2015, 03:32 AM


Group: Member
Posts: 187

Are you online mobile? I think there is no mobile version
  Forum: By Share Code

CUV88
Posted on: May 22 2015, 03:02 AM


Group: Member
Posts: 187

Not sure it was posted already, but there is a new item in the menu on the clinuvel homepage: "Pipeline"
http://www.clinuvel.com/en/pipeline
In my opinion it clearly describes CUV9900 as the platform and VLRX001 as a new formulation. And there will be more formulations build on the foundation CUV9900 in future.

So clinuvel is working on their homepage, giving panel discussion in singapore, discussing prices in the UK. Just not telling anybody. As long they work fine...
  Forum: By Share Code

CUV88
Posted on: May 15 2015, 11:51 PM


Group: Member
Posts: 187

Other than that, its nice he is building his network in singapore.
  Forum: By Share Code

CUV88
Posted on: May 15 2015, 11:44 PM


Group: Member
Posts: 187

PW is going to talk about: "Building and maintaining positive relationships with stakeholders." Thats going to be interesting, since he is not talking to his shareholders .., thought we are also stakeholder
  Forum: By Share Code

CUV88
Posted on: May 12 2015, 06:45 AM


Group: Member
Posts: 187

Thanks snaffew, why do you think at best 30k of $107.369?
  Forum: By Share Code

CUV88
Posted on: May 12 2015, 06:34 AM


Group: Member
Posts: 187

Retro First Quarter 2015 Financial Results are out:

http://amda-1pla2o.client.shareholder.com/...eleaseID=912367

No word on clinuvel. Can somebody read between the numbers if sales of CUV took place or not?
  Forum: By Share Code

CUV88
Posted on: May 10 2015, 09:16 PM


Group: Member
Posts: 187

Pity there is no "say blabla" button
  Forum: By Share Code

CUV88
Posted on: Apr 27 2015, 03:10 PM


Group: Member
Posts: 187

Here again my contribution with new numbers, since people seemed to like it
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CUV88
Posted on: Apr 25 2015, 07:10 PM


Group: Member
Posts: 187

Clinuvel is no.1 on sharescene regarding amount of views:

Views:
CUV 2,934,128
SLA 2,441,127
CST 1,128,382

Also we only need about 30 more comments to step up in the replies ranking to no.3:

Replies:
SLA 42,941
MST 25,197
CST 22,022
CUV 21,994

It is really impressive this small biotech is getting to the top, although there was not to much publicity and the big events are still ahead of us!
  Forum: By Share Code

CUV88
Posted on: Apr 19 2015, 07:30 AM


Group: Member
Posts: 187

"Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has reached agreement on terms and conditions with Biotech Lab Singapore Pte Ltd (BLS) to enter a joint venture (to be called Vallaurix Pte Ltd) for the final development of formulations for paediatric use of afamelanotide, and CUV9900, a novel melanocortin peptide for topical application for skin care. Clinuvel retains a majority interest in the partnership. The financial terms have not been disclosed."

I would like the topical formulation with cuv9900 for pediatric use. Way better than the small surgery to get the implant into the kids! Also that would speed everything up.
  Forum: By Share Code

CUV88
Posted on: Apr 13 2015, 05:19 PM


Group: Member
Posts: 187

We all do know, that there is no communication... The question for me is, why is there no communication? Do you guys really think PW and his team are just to lazy. Or do you think he just doesnt care about the investors? Maybe he is too busy to give us some update? But there are some clever guys on the CUV board including PW. So my personal opinion is: there is a strategic reason for the silence. The history of Epitan with its cosmetic marketing approach failed and since then the company had to be very careful with the authorities. We do have a product that is approved under "exceptional circumstances" in Europe. If Clinuvel wants to get an approval also from the FDA, maybe they want to do it without to much media and publicity on them.
  Forum: By Share Code

CUV88
Posted on: Apr 10 2015, 11:29 PM


Group: Member
Posts: 187

For everybody whos interested i attached a graphical summary of the quarterly figures of the last 5 years. You can see Clinuvel reduced payments for research and development drastically. Additionally there is a regular income for receipts from customers. Fix costs stay constantly low. All together we are moving to a break even in net operating cash flow and should have a profitable company in foreseeable future. Ignoramus or anybody else of the critical people having a destroying comment on this?

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CUV88
Posted on: Apr 10 2015, 10:58 PM


Group: Member
Posts: 187

Just watched a recording, no word on scenesse or clinuvel
  Forum: By Share Code

CUV88
Posted on: Apr 10 2015, 10:22 PM


Group: Member
Posts: 187

Hi royco,

how do you want to compare/benchmark the numbers? Looking at the receipts history of Q1 in the last years its an up and down:

2014: 197000 AUD
2013: 275000 AUD
2012: 40000 AUD
2011: 171000 AUD
up to 2010: 0 AUD

So would 250000 in receipts in 2015 be better or worse than our expectations... Since its higher than 2014 but lower than in 2013. etc
I would be interested in your view on evaluating the next appendix 4c.

Thanks and best regards,
CUV88
  Forum: By Share Code

CUV88
Posted on: Apr 8 2015, 12:44 AM


Group: Member
Posts: 187

It will air on april 17, 2015 ( comment from desiree lyon )
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  Forum: By Share Code

CUV88
Posted on: Mar 25 2015, 07:53 PM


Group: Member
Posts: 187

Well if you would post something useful people might quote you as well. Maybe even in a positive way...
  Forum: By Share Code

CUV88
Posted on: Mar 25 2015, 04:56 PM


Group: Member
Posts: 187

Hey all,

YES, there is a lack of communication from Clinuvels Management. And YES the Share Price should be definitely higher already.
But do we know if the share price rises at a regular communication from PW? I don't want daily updates with the same content over and over again.

Philippe Wolgen could communicate his strategy in public but then we might have a problem, since media turns every achievement and future vision regarding scenesse into a "barbie wonder drug" headline.
Until FDA has not approved the drug in any form, this is not the publicity we need.

Since i am not an expert, i like to read the opinion of people who are professionals in their field.
And since on this Forum everybody is posting a subjective, anonymous opinion i want to repost the letter from Florian Homm, who wrote a more objective view than ours on google groups in December '14.


"Dear Uhohinc,

your research is amazingly in depth. You even quoted my book, Rogue Financier. That is thorough stuff.. I am leaving this little post with you. On November 5th I will hold a speech at a University in Erding, Bavaria, north of Munich before a few hundred students and about a dozen people from the media. Clinuvel will feature quite prominently in this speech as the investment, providing me with great emotional gratification especially after the EMA approval. I was fortunate to finance this company. Quite frankly, our funding prevented this jewel from going bust and we actively searched the market for credible, science oriented management. I leave this little commentary with you to make available to others on share scene and other boards. I have followed Clinuvel very closely for years even during my 15 months in prison fighting extradition to America. I will touch on a few issues (not just these very narrow financial concerns) that may be of interest to you and others:

Valuation:
In the absence of serious research the shares are absurdly misplaced. During my illustrious career I received numerous investment awards (european hedge fund manager of the year, top us specialty fund manager, number one germany fund, European pension fund, blah blah blah). I have written over 500 research reports for the likes of Fidelity, Merrill Lynch, tweedy Browne, VMR AG, ACMH Group etc etc... I have a reasonable idea of this business. Here we go:
Revenues of USD 40 to 70 Million for EPP is realistic. But get to the pretax or net profit figures! On EPP alone, Clinuvel may trade at only 5 times 2016 or 2017 earnings. I have not the slightest doubt that EPP alone is worth AUD 5-7 per share right now. You have to look at Vitiligo separately! This a sum of the parts evaluation. I was the original proponent to encourage CUV to consider Vitiligo, but Dr. Wolgen took it the critical step further: not as a stand-alone treatment but as a combination therapy. Here are some facts which will blow your mind: there are no less than 1.2 million vitiligo treatments per year. Some world class sources say the number may be between 1.5 and 1.8 Million. I love using lowish numbers in my models. If the low balling works and I do not have to twist the math - so much the better. It is utterly realistic that CUV may get USD 5K to 7K per vitiligo treatment. It is increasingly evident, that the combination therapy is so much more effective it will over a few years largely wipe out the traditional treatments. I would be very surprised if CUV does not reach abut half of the market in annual vitiligo treatments, certainly no less than 500,000 treatments a year as the market will quickly learn about CUV's vastly superior product. USD 3.5 Billion in sales. What do you thing the bit margins are on this product? It is not unrealistic that CUV generates USD 1 Billion or more in net profit by 2018/2019. Some of the things you say make serious sense as well. How about off-label use for extreme vitiligo cases? Or how about the hundreds of thousands who get skin cancer after organ transplants. Would CUV work there. Worth a try certainly. Always better than the risk of malignant, at times deadly skin cancer. Or how about those extreme Fitzgerald 1 types ultra prone to get skin cancer even with only modest sun exposure. What is beautiful about the modeling now is that with EMA approval and 95 percent likelihood of FDA approval the shares have basically done nothing. There is not a single first rate research report on CUV! That is incredible and difficult to fathom. It is also a once in a lifetime investment opportunity. Do not get lost in all the blah-bla micro details in these posts. Buy, put away and then cash out of your ten, twenty, thirty or forty bagger. Yes, that is possible and probable. There is no chance this undervaluation persists for more than 6 to 12 months. None. Vitiligo is progressing quite quickly, quarterly EPP profit figures will show exponential growth and patient numbers in the US and Europe may even surprise on the upside. For a proper valuation you need to strip out all R&D, OH and simply take COGS and Marketing/Sales. Vitiligo, the same but get ready for USD 50 Million to get to full FDA approval. If I use 50 million shares outstanding (conservative) CUV is worth 12 to 15 AUD per share at this very moment. 300 for EPP and 450 for Vitiligo. In an organized auction process, CUV would easily get USD 10 per share. Cash!

Threats:
There are three: A takeover. CUV, at this price is a sitting duck. It needs to be on NASDAQ asap. Top senior management (mostly Dr. Wolgen) needs to stay for at least the next 5 years and he needs to upgrade his team for a rather demanding Vitiligo approval process. Unless you have been in this space for a few decades (I have) you do not appreciate obtaining regulatory approval for a treatment which simply does not fit into the classical approval methodology (placebo or double blind design was absolutely not possible). The Scenesse approval by the EMA was the first ever, which integrated patient/doctor groups in the decision making process. That is a monumental achievement. The product pricing is amazingly good and much better than I ever imagined when I got involved about a decade ago. I see shareholders moaning about compensation levels. That is beyond absurd. This company is already global, operating in Europe, Australia, Singapore and the US. Compared to those companies compensation levels are well below average and what I view as a serious risk - management only has a tiny stake in this company. Their interest are not properly aligned with shareholders. It is always the same risk. A well payed manager may sell out a company well below price if his personal stake is small. He may opt for a fat golden parachute instead. CUV top management owns about 4 percent of the company. Get real. 10 percent, some for EPP and milestones like NASDAQ and the mother of all approvals vitiligo. This is a serious risk. Of course an opportunistic takeover at AUD 7, 10, 20 or even 30 is another heavy risk. You are sitting on a potentially huge gold mine and someone literally steals it from under you. The third serious risk is execution. Dr. Wolgen is key and few very focused members of senior management. Retain, retain, retain and motivate. So simple. Upgrade that board and senior management for NSDAQ because this is no longer the Queensland Cup. There are so many clowns running around (an Australian dentist (madman on share scene), Retrophin under Shkreli, some suspect, "concert party" hedge funds) who have no idea what has been achieved and what remains to be done. This stuff is micro-management, persistence requiring the highest possible degree of credibility and operational focus. Regulators hate disruptions. Management disruptions, and all too frequent board shuffles are toxic and at best delay regulatory procedures. At worst they can derail them entirely. I have hired and fired hundreds of senior executives. Those wannabe entrepreneurs offer nothing but populistic generic hogwash. Madman has a sharp mind, but stick to the research Mr. Jones. I like what I read from you and Poontz as well, but get the big picture....grasp the complexity.

The Human Dimension:
I do not own a single share. I will not own a single share. I used to serve Mammon. I have zero motivation to pump CUV. I want millions to be treated and cured. I want people to be hopeful. My masters are God, Jesus and Mary. I am so grateful Scenesse was approved. I wish all of you great fortunes with CUV, but give some back to great causes when you cash in that CUV check. On a fifteen year viewpoint, Scenesse may even succeed to help those most likely to contract skin cancer. Vitiligo is very damaging emotionally. EPP suicide rates are very, very high. At least half of those obtaining organ transplants get skin cancer. Hundreds of thousands of lives may be saved, millions will improve. Many of these folks have been without hope. That is what pleases me most. CUV gives hope, not just superior investment returns. It gives me a kick, that between all the raids, dozens of IPOs, short sales, VC deals and so forth there is this one company which makes me happy to bee associated with: Clinuvel. How often in life can you invest and reap a serious fortune and do something really good at the same time? Well? I have done hundreds of deals in a thirty year career. Such a benign and virtuous mix is incredibly rare: once in a lifetime for me. So you intense investors.....do not forget the human dimension and consider if CUV becomes this multi-bagger as I am predicting (anybody who had bought Rogue Financier and bought CUV shares would have made more than 300 percent), give to those in need and those who are less fortunate than you.

Viel Glück

Florian"

So i think we need to keep PW, and btw. he is not the only one in Management. Also Clinuvel just added Willem Blijdorp. Mr Blijdorp was awarded by Ernst & Young Netherlands as Entrepreneur of the year 2014.

Best regards
CUV88
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CUV88
Posted on: Mar 10 2015, 08:19 PM


Group: Member
Posts: 187

Yes, little sparkles in my eyes when i think of my CUV holdings.
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CUV88
Posted on: Mar 10 2015, 03:37 PM


Group: Member
Posts: 187

RC, if you want to play some numbers check the AGM presentation http://clinuvel.com/resources/pdf/20141128AGMSlides.pdf. Slides 27-29.
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CUV88
Posted on: Mar 10 2015, 03:03 PM


Group: Member
Posts: 187

That is indeed a very good question, what everybody should be curious about now. The recent silence of CUV management is even for clinuvel odd. We can ask ourself IF the health insurances will reimburse SCENSSE. And in my opinion they will, just look at switzerland and italy. They even paid for the drug when it wasnt approved in the EU. Now the next question is, at WHAT price. Thats what keeps PW so busy that he can't even write a small business update.
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CUV88
Posted on: Mar 10 2015, 02:41 PM


Group: Member
Posts: 187

Actually the only news the dutch site (http://www.epp.info/pages/2/nieuws/) has, is about scenesse. Also with radio interview.
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CUV88
Posted on: Mar 10 2015, 02:32 PM


Group: Member
Posts: 187

Scenesse is well known in the EPP Community. Especially the german (epp-deutschland.de) dutch (epp.info) and the american. If you check the homepages and Facebook groups you will find patients waiting and demanding scenesse. There is going to be an international patient day in germany in Düsseldorf (http://epp-deutschland.de/mediapool/21/211484/data/International_Patient_Day_Sept_13th_2015-eng.pdf) Scenes is mentioned and will be presented by Prof. Elisabeth Minder from switzerland. Also Desiree Lyon, President of the American Porphyria Foundation will be there. She is a very active member and always in contact with the FDA. She is know for her passion and already knows how to talk to the FDA. I am not saying everybody who has EPP knows about scenes, but many definitely do! At least the important, leading people in this field.
  Forum: By Share Code

CUV88
Posted on: Mar 10 2015, 02:13 PM


Group: Member
Posts: 187

Tonight is not that bad! 3,5 AUD with +9% right now smile.gif
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