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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Johnny H
post Posted: Today, 06:02 PM
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In Reply To: sharelooker's post @ Today, 04:13 PM

Thank you! I don't know how I missed your June 5th post. It has everything!

It seems that they really earned that CRL. 2 jaw droppers:

-"verifying the reliability of Cmax data and providing justification for non-applicability of the agreed-upon and prespecified Cmax secondary endpoints"
If you think you need some wiggle room to shift your endpoints after the fact when the results don't go your way.... for the love of god, DO NOT agree to pre-specified endpoints with the FDA. Changing agreed-upon endpoints without justification is a 100% guaranteed way to elicit a negative reaction from FDA reviewers and voting committee members.

-"obtaining definitive evidence pre-approval via an ambulatory blood pressure monitoring study as to whether TLANDO causes a clinically meaningful increase in blood pressure"
A testosterone replacement therapy with known cardiac side effects, intended for older men.... and they didn't do something as simple as a proper blood pressure monitoring study???



It appears that their advisory committee meeting was already scheduled before the PDUFA date was extended (but had not yet taken place), so perhaps the FDA couldn't determine if 1st cycle approval was likely until the results of the Adcom vote.

Either way, if this is the one counter-example to the trend, I'm pretty excited. Like you said, the chances of approval went up after Clinuvel announced the extension.

The fact that the FDA communicated to Clinuvel from the outset that it had no intention of calling an AdCom meeting indicates to me that the FDA is not on the fence about this decision at all.

And.... If the FDA were to call an Advisory Committee meeting, which they can do up until the end of the business day today (Friday, 5PM EST), the results of the Adcom would probably be unanimously in favor of approval. The FDA is well aware of this from the patient workshop (one of the first of its kind ever).

In hindsight, I think that if not for the contract manufacturing issues, it's possible that the FDA would have been on track for an expedited approval (approval a full month or more ahead of the original 6 month deadline). The labeling deadline was 3 months before the original target date, and now, it's only 1 month before. You have to wonder what the FDA was planning to do with those extra 2 months.

Anyway... I thought I would start getting more nervous as we near Oct 6, but the opposite is true.


Thanks for the data points!










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Clinuvel until my bowels release for the last time.

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LevelHeaded2000
post Posted: Today, 05:51 PM
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4 green days in a row. If I was a shorter I would begin to get very nervous. My guess is that once it is >= $20 USD that the shorters will begin to feel a bit of a panic.

Regarding any change in dividend, I hope that they do not raise the dividend much if any. I would actually prefer them to get rid of the dividend. Here are my reasons:
  1. Clinuvel will be transitioning to a growth strategy. They will need money to fund trials, so they have areas where dividend money can be spent for ROI. Unless they can get cheap debt financing there is no point to issue big dividends only to have to dilute later or severely limit the number of indications they can tackle in parallel due to lack of funds.
  2. A large portion of Clinuvel holders are holding the ADR (I believe it is 25% or so, but don't quote me). Any dividend provides negative shareholders value for ADR holders. So, the higher the dividend becomes the less sense it makes to hold the stock. The reason is because a substantial portion of the dividend gets eaten by the ADR administrator.



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sharelooker
post Posted: Today, 05:18 PM
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Could be a nice rally next week:

- Light and Life Conference
- Announcement of dividend policy
- Pre-annual report
- If no annoucement of a further adcom meeting, approval is a done deal



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polyphemus
post Posted: Today, 04:23 PM
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In Reply To: Verharven's post @ Today, 11:58 AM

I think profit will be $33m with a 3.5c div.


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sharelooker
post Posted: Today, 04:13 PM
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In Reply To: Johnny H's post @ Today, 11:52 AM

I did the same analysis some month ago and i found only one drug ('TLANDO') that wasn't approved even after the three month extension. However, during the extension period the FDA scheduled an adcom meeting that voted againt the drug (13 vs 6).

https://boards.sharecafe.com.au/index.php?s...=27&st=1130

Extension of PDUFA:
https://ir.lipocine.com/U-S-FDA-Extends-Rev...mains-Unchanged

Outcome of adcom:
https://ir.lipocine.com/2018-01-10-Lipocine...th-Hypogonadism

CRL:
https://ir.lipocine.com/2018-05-09-Lipocine...-Administration


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Verharven
post Posted: Today, 11:58 AM
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Last year, preliminary financial results and dividend announced Wednesday, August 29. The year before it was Wednesday, August 30 so expecting this mid next week. I'm going for a $0.05 divvy


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Johnny H
post Posted: Today, 11:52 AM
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In Reply To: Clinhope's post @ Today, 10:33 AM

Every incidence I've been able to find is from 2012 or earlier, and it appears to be so because the law has changed.

Congress has to reauthorize the Prescription Drug User Fee Act (PDUFA) every 5 years, and each time they do, they make changes and improvements.

Every example of a PDUFA extension later resulting in a CRL in the first cycle (that I have been able to find, anyway) occurred in 2012 or earlier, which was under the laws of PDUFA IV (the 4th reauthorization, legally in force from 2008-2012).


PDUFA V was approved in 2012 and in legally in force from 2013 to 2017. Currently, PDUFA VI is legally in force from 2018-2022.

Both PDUFA V and PDUFA VI have the specific language: "FDA’s decision to extend the review clock should, except in rare circumstances, be limited to occasions where review of the new information could address outstanding deficiencies in the application and lead to approval in the current review cycle."

I can't find the exact text for the laws in PDUFA IV, but I would assume that the language is not in there. I CAN confirm that the language was was NOT in PDUFA III (see attached).

It would appear that the FDA adopted the policy of only extending the review when it would lead to 1st cycle approval sometime in 2013 ish.

So... the question is... have there been any recent (last 5 years) PDUFA extensions that later resulted in a CRL? If so, what were the rare circumstances?

I still haven't been able to find any. Anyone else?

This almost seems too good to be true. There has to be at least once example that we can discuss and learn from.

If not.... beer me... because this might be a done deal.
 




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Clinuvel until my bowels release for the last time.

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Clinhope
post Posted: Today, 10:33 AM
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I was looking for companies that I managed to find some other interesting cases that received an extension but are a little bit different.

Eliquis by Bristol-Myers Squibb Company and Pfizer.

In March 2012 they received the three month extension.

By late June 2012 they received a CRL!

Late September 2012 FDA accepts resubmission.

December 28th 2012 FDA approves Eliquis.

Bivigam by Adma Biologics did the same with an extension, CRL due to "FDA running out of time to review their extensive submission package."

So there are two companies that seemed to be in a very bad situation and received extensions and CRLs and went on to be approved.






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Member of the “ALL-IN” club 2018.

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Dr Wally
post Posted: Yesterday, 12:40 PM
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It must be incredibly exciting for a professional person in this space when they first hear about the incredibly effective photo protective and therapeutic (game changing) qualities of scenesse.

Would be nice get a review of some kind about the going’s on at this event while we twiddle our thumbs waiting for the inevitable (US approval) to occur.😑



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50+ on or before PDUFA... GLTA that have seen the future and kept the faith. 😎 Scenesse 100% will be approved. Too safe, too beneficial to the health of millions. Logic and community pressure will eventually prevail over regulator ignorance.
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waz
post Posted: Yesterday, 09:52 AM
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CLINUVEL PHARMACEUTICALS LTD today announced that its program in systemic photoprotection will be discussed and presented at the first European-American meeting of the International Congress on Photobiology and Congress of the European Society for Photobiology, Light and Life, held in Barcelona, Spain, from 25-30 August.

CLINUVEL is convening both a symposium and keynote lecture on photomedicine for the attending medical community. To increase its engagement with expert researchers and clinicians interested in CLINUVEL’s R&D stages, the Company is hosting exhibition space.

Attached File(s)
Attached File  Announcements___2019_08_22T094751.878.pdf ( 149.8K ) Number of downloads: 68

 



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