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CUV, CLINUVEL PHARMACEUTICALS LIMITED
andymen
post Posted: May 2 2019, 10:34 AM
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In Reply To: Hamster72's post @ May 2 2019, 10:29 AM

I stand corrected. Apologies.

 
macgyver
post Posted: May 2 2019, 10:33 AM
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In Reply To: LJS's post @ May 2 2019, 10:12 AM

Agreed. A timely reminder that we're not quite there yet.

A NASDAQ listing will probably not occur until after approval, which might be delayed. Yet PW is pressing the flesh with institutional investors abroad, I assume in anticipation of listing.

 
Hamster72
post Posted: May 2 2019, 10:29 AM
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In Reply To: andymen's post @ May 2 2019, 10:24 AM

He said 50/50 chance of approval vs CRL


“In conclusion, while the probability of a US approval versus a CRL are equally weighted at this point of the Priority Review, our teams are striving to satisfy the frequent queries lodged by the FDA. As our Chair recently stated, given the legacy of the Company, we are determined to overcome all conceivable obstacles, and maintain a relentlessness in our “

That would explain the sell off earlier this month.



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Dr Wally is not a doctor at all. He's a dentist.
 
andymen
post Posted: May 2 2019, 10:24 AM
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In Reply To: LJS's post @ May 2 2019, 10:12 AM

He didn't say it's a 50% chance of approval, he said 50% of the risk:benefit equation is safety. Or to quote:

"The target for our teams over a decade has been on management of the safety profile of SCENESSE® since the drug’s “safety” forms the basis of the regulators’ scientific opinion on risk, 50% of the risk-benefit evaluation."

Safety of the drug is excellent, so your initial 75% probability is still conservative IMO. I would put it at ~90%.


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LJS
post Posted: May 2 2019, 10:12 AM
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In Reply To: sharelooker's post @ May 2 2019, 09:42 AM

Seemingly a timely reminder that the process is not a slam dunk at this point. I think PW is pragmatic but conservative so a 50:50 hopefully is better than it looks. It's certainly less than my 75:25. If we can move to the labeling issues point at some time soon this would be a positive, albeit missing the April 8 date is a little alarming. Meanwhile Europe forges ahead and the USA will happen at some point, it remains a matter of timing which does not assist those awaiting access. GLTA


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sharelooker
post Posted: May 2 2019, 09:42 AM
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Newsletter is out!

https://www.asx.com.au/asxpdf/20190502/pdf/...sdwp551f27h.pdf


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Hamster72
post Posted: May 2 2019, 08:53 AM
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In Reply To: Verharven's post @ May 2 2019, 06:10 AM

That’s great news on Fidelity. I honestly thought it would take another month or two. Lagoda on the other hand is illusive and tough to track. I’d be surprised if they haven’t sold a good chunk as well but just speculating. That’s a lot of selling pressure taken out of the market. Do we go to new highs now prior to approval?



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Dr Wally is not a doctor at all. He's a dentist.
 
Verharven
post Posted: May 2 2019, 06:10 AM
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Insto and fund ownership updated to April 30 (click on the ownership tab) https://www.morningstar.com/stocks/pinx/clvlf/quote.html

Fidelity is now out! Vanguard picked up all of their shares as they added ~948k over their various funds in the month of April (click on the 'Funds' and 'Institutions' tabs to see this)


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scipio79
post Posted: May 2 2019, 06:10 AM
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Joined the final buy-in club yesterday and today. GLTA


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rabbitrun
post Posted: May 2 2019, 04:47 AM
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http://www.cureffi.org/2019/04/29/financia...n-rare-disease/


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