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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Dr Wally
post Posted: Today, 12:37 AM
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If it was at all possible to get things happening in the US 6 months earlier, and they didn’t make it happen, after all the years that have been thrown down the shitta already, then it wouldn’t just be their business savvy in question, their sanity in general would surely be of greater concern.

Are these guys really that naive or stupid? Im praying that their not.

I look at the way their managing the financial side of the business and thats what gives me confidence that (now the elusive FDA hurdle has been cleared) they've got their sh1t together and everything is going to be ok and 2020 will be a monumental year for us all. king.gif



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The never ending quest to have Afamelanotide (peptide) accepted for its potent ability to stimulate a natural photo protective therapeutic “tan” was accomplished in 2019.
 
seeva222
post Posted: Yesterday, 05:23 AM
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In Reply To: Johnny H's post @ Yesterday, 04:18 AM

Every dollar they spend on the rollout will come back to them quickly and many times over. It’s not like this is R&D that will take years to recoup. That money comes back immediately. I completely get fiscal conservatism, but this is immediate return.


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Johnny H
post Posted: Yesterday, 04:18 AM
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In Reply To: xlnja's post @ Yesterday, 03:51 AM

Exactly. There's a reasonable middle ground.

They don't need to license out or give up control. But a $1-2 million consult with Icon PLC to jumpstart distribution would be nice.


Rolling out 6 months earlier would mean an additional $10-$15 million in revenue that would otherwise be lost, and also helps protect against competition. Totally worth it.



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Clinuvel until my bowels release for the last time.

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xlnja
post Posted: Yesterday, 03:51 AM
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In Reply To: PortugueseMan's post @ Dec 13 2019, 10:27 PM

I understand PW's desire to keep everything "in house". That kind of thinking goes with his background in medicine where you have to become an expert yourself instead of relying on external resources. I'm speaking in terms of their practice of having existing employees handle the rollouts, submissions, etc. While this approach keeps costs down and increases employee knowledge and value, it is also very slow. Can you imagine trying to figure out the rules and regulations for all the EU countries and the U.S.? Without experience in those areas, you figure out things as you go and often don't know what you don't know. If we had an unlimited amount of time to do all the rollouts without competition and could wait 50 years for returns, this might be fine, but speed is needed now to capitalize as soon as possible. Get some experts to move this thing along.


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Desert Rat
post Posted: Yesterday, 03:47 AM
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Rhythm Pharma has completed phase III enrollment of their setmelanotide trial in the ultra-rare obesity disorders Bardet-Biedl and Alstrom syndromes, but it is only 32 and 6 patients, respectively. Those two MC4r-related obesity syndromes have a US prevalence of only 2,500 and 500, respectively. They expect to have top-line results in late 2020/early 2021. Their other phase III trial in the more common types of MC4r mutation-mediated childhood obesity syndromes (POMC and leptin receptor deficiency) is on course for top line results, possibly mid 2020. Since Vyleesi hasn't seemed to catch fire yet, to put it mildy, Scenesse still remains the most widely-used melanotropic peptide world-wide, and esp. if they can get distribution going for EPP patients in the US.

https://finance.yahoo.com/news/rhythm-pharm...-130010299.html



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Johnny H
post Posted: Yesterday, 03:37 AM
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In Reply To: investek's post @ Dec 13 2019, 09:49 PM

The impression I got is that Bull was instructed to conduct IR in this fashion. He was open and responsive at first, and then something changed. He probably received the same instructions as Keamy: avoid replying to investors unless you are legally obligated to do so.

If Bull was hoping to transition from a career in banking to a career in investor relations, he picked the wrong stepping stone.

Having a bull isn't very useful if he's castrated.



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Clinuvel until my bowels release for the last time.

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Dr Wally
post Posted: Yesterday, 01:34 AM
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The interviewer “Tom” must have been advised by PW that he wouldn’t be talking about anything to do with Scenesse or surely he would have “drilled down” into 1 or 2 subjects like US rollout, photoprotection = skin cancer prevention, transdermal formulation or even DNA repair. There's so so much to be talking about right now but alls we get is talk of shorting and financials, not suggesting for a second that the financials are not extremely important.

For PW to have a platform like that and not even go close to mentioning anything at all related to the FDA approved Scenesse is strange.What reason could there possibly be for deliberately ignoring critical subjects at a time when he has the spotlight on him like this? Something is definitely up here but I honestly think that when we're finally informed (2020 ph34r.gif ) its going to be all good and not at all bad.

I've got a feeling that something substantial has taken place at some stage this year that has dramatically changed their plans and some reform has been taking place and this is why at a time when information about so many things should be flowing from the company it’s mystifyingly not happening.

We know that the drug is brilliant and not in question anymore as the FDA have capitulated and completely cleared the road moving forward of any nasties so I can't think of any other reason (other than this management are sh1t of course) for this kind of behavior post FDA approval. .



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The never ending quest to have Afamelanotide (peptide) accepted for its potent ability to stimulate a natural photo protective therapeutic “tan” was accomplished in 2019.

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seeva222
post Posted: Yesterday, 12:01 AM
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In Reply To: andymen's post @ Dec 13 2019, 03:40 PM

It’s not more convenient and keeping to a regimen like that is hard. Pills and creams are hard to keep up with.

 
KRD
post Posted: Dec 13 2019, 11:23 PM
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In Reply To: CUV88's post @ Dec 13 2019, 01:18 PM

Just checked out the ComSec interview. Glad someone is getting their regular dose of Scenesse. Never seen PW look so tan before.


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PortugueseMan
post Posted: Dec 13 2019, 10:27 PM
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Well, here you have a curious thing: Analysing criteria for price and reimbursement of orphan drugs in Spain

The authors of this study, published on 26 july 2019, already knew that AEMPS rejected Scenesse for reimbursement (see table 2). This was 3 months before the publication of the TPR, on 30 october 2019. Did management also know, back on july, about the AEMPS' rejection?

Regarding PW's interview, I missed some updates on marketing authorizations in EU countries, such as:


- the reason why Spain and Norway rejected Scenesse was pretty much the same: not enough data (safety, efficacy, whatever...). It is not supposed that, 5 years after EMA approval and 3,5 years after the first commercial deliveries, we already have enough data to present and completely refute those decisions? Or will we give up on these two markets?

- how long will we wait for NICE to answer? one more month? one more year? Since the appeal decision was crystal clear ("...it was unreasonable for the committee to state that the trial results show small benefits with afamelanotide..."), why not go ahead, right away, with a lawsuit?

- an official confirmation that the reimbursement dossier will be handed over to the french authorities until the end of the year.

- what about Sweden, Denmark and Finland? (with a total of 160-200 EPP patients)




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