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CUV, CLINUVEL PHARMACEUTICALS LIMITED
johnnytech
post Posted: Today, 05:08 AM
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In Reply To: royco's post @ Yesterday, 08:33 PM

Royco, it does seem to put the horse in front of the cart to approve labeling in advance of approval, but the overall process is designed to include the minor details like this so the drug is marketable on July 8. As with all application approvals, the approval is effective immediately. Clinuvel can literally sell the drug same day as approval and thus all the details need advance sorting out.

Another example of this is last fall the FDA even added manufacturing inspections to the approval process (which we aren't affected by I think because of the timing of the policy announcement), which were previously a case by case detail or a later event like a health inspector might surprise inspect a restaurant.

As for any info conveyed to us in April, I have zero expectation that we will see an announcement. I hope we do because it keeps the stock going north, but that is secret private work product and no obligation to disclose.

 
Verharven
post Posted: Today, 05:04 AM
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In Reply To: royco's post @ Yesterday, 08:33 PM

I wouldn't put too much significance on the July 8 date as this is more an aspirational target for the FDA. From data I posted previously, based on the last 3 years, the median approval time for a priority review was 8 months and ranged from just over 90 days to almost 2 years so I would treat the 8 April as the starting point where news could arrive 'any day'. Considering the FDA has had many years to take a look at Scennesse under the rolling review and it has EMA approval I am mildly optimistic that it could be a shorter review time.

 
rabbitrun
post Posted: Today, 03:06 AM
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So easily this could have been us. Thankfully, we’re on a different path.

https://www.fiercebiotech.com/biotech/aerpi...-eye-study-flop

 
IntiRaymi
post Posted: Yesterday, 09:29 PM
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In Reply To: royco's post @ Yesterday, 08:33 PM

What if, Royco, the labelling decision is made these three months in advance of the July decision for IF there is approval? I.e these are the parameters put in place should the drug be allowed to come to market. Maybe this kind of documentation is quite trivial and easy to produce


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sharelooker
post Posted: Yesterday, 08:59 PM
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BTW the new Acting FDA Commissioner was a co-founder of a biotech called Sapere Bio that focuses on cell-aging and senescence.


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sharelooker
post Posted: Yesterday, 08:43 PM
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https://www.cash.ch/forum/boerse/aktien-aus...maceuticals-ltd

Good morning Mela

Thank you for your interest! But you have a lot of questions for an "unaffected" Wink

I'll try to answer one or two questions. In any case, I find it exciting that you have contacted us. I just write - don't be embarrassed to ask further questions. The questionnaire is a bit stupid. There are probably about 10 pages full of questions that I would formulate differently or even ask completely different. The questions are primarily about the current status of changes/improvements in dealing with EPP - so what has changed since the last implant. Dress habits, how did I expose myself to the sun/light, did I have EPP Schüber etc.? Duration approx. 30 minutes. Basically I think it's good that (whoever) wants to know what is changing. The total duration of the 'treatment' is about 1 hour. The implantation of the implant seems difficult to me - it needs experienced hands! The syringe goes under the skin, so that the medicine can spread best. It takes about 10 days until the whole substance is released. After only 3 days a tan is visible and the light protection is activated and becomes stronger and stronger - for about 2 months, then it decreases again. There are different strong EPP- characteristics. The stronger the more often an implant is necessary to be protected the whole year. For example, I only need 3 implants! I cannot judge the load for the evaluation of the questionnaires of an institute. I find the word "load" unsuitable - an implant costs about CHF 17'000.- and the institute/spital certainly earns it. At least once a year you have to give a blood sample and urine - these will be examined for changes because our liver is especially burdened with protoporphyrin. Also every year the skin has to be examined, especially with the treatment scenesse for skin cancer. NEW we EPPler go also to the sun... hihi... So process: Give blood, inject implant, give urine, fill out questionnaire.

The LIFE WITH scenesse is a NEW life - all EPPers confirm that to you. Pain is gone, shadow running is no longer necessary, social restrictions as well as professional are almost gone, sports are almost all possible...you can already imagine when a legless person suddenly gets 2 functioning legs or sees a blind person again? One should not underestimate EPP. The illness WITHOUT scenesse is very difficult to bear and needs much courage and willingness to suffer and perseverance. It has a massive impact on the EPPler!

Scenesse has massive potential - Cliunvel is also working on it. Skin cancer prevention, beauty industry and possible cell renewal (reduction of cell aging) are only the most important application areas of Clinuvel's drugs. There are more features by entering scenesse, but I don't want to declare them here because they are not official.

So that would be for now. As I said - just ask...

Dear greetings, star hour

Translated with www.DeepL.com/Translator


Said 'Thanks' for this post: Dr Wally  royco  odi01  IntiRaymi  NewToCli  seeva222  blackm3  Texas T  
 


royco
post Posted: Yesterday, 08:33 PM
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Martket cap of 1 BN USD attained.cuv is passing this important milestone of credibility.What a journey.
In my opinion cuv is worth double today based on the growth figures from the recent past and those expected for the near future.The profitability is great, they have zero debt and a nice pipeline of new products or applications in preparation.
The FDA decision is a next turning point for credibility and visibility but also the starting point for cuv to increase the speed of development on many fronts.
What I do not understand is how the FDA can issue a decision on the labelling and post marketing commitments by April 8 and then wait another 3 months before the 8 July overall marketing decision.
Scenario 1:
8 April the FDA communicates the labelling and post marketing commitments to clinuvel.Then I can only deduct that SCENESSE will be approved. Why else go through the efforts to let them prepare all of this if not to start marketing in 3 months time? I presume the 3 months are meant for clinuvel to get their ducks lined up before marketing starts.

Scenario 2:
8 April the FDA does not communicate any labelling or post marketing commitments to clinuvel.By logical deduction the FDA thinks the product is safe enough and well labelled as it is presented in the EU currently.
So how on earth would it then come to any other conclusion then to approve in July? Hence, why do they need 3 months more?

In other words I presume that the April 8 news or no news from the FDA concerning the labelling and post marketing commitments is all encompassing for the July 8 decision. By doing a little more work on the why and how you can find out that approval chances are VERY close to 100% and you have the information 3 months ahead!
I would find it more logical that if the FDA would issue no news on April 8 they should decide very shortly after on the marketing of SCENESSE in case there is no further need for labelling and post marketing adaptions.

There is also a third scenario: delay








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Ἀρτεμίσιον

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Verharven
post Posted: Yesterday, 03:12 PM
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No after-market close shenanigans today, but still, 32k shares going through at 4:10 pm to finish the day on a volume of 173k is not bad at all.

Fun fact: the number of days prior to 2019 where daily traded value exceeded $2M was 17 and all but 3 of those were in 2018 (2 were in 2014 when EMA approval came through and the other an aberration from a bulk share transfer in 2008 of $17M for the day). Number of days we've gone past $2M this year so far is....20


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PunkassDerm
post Posted: Yesterday, 01:44 PM
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Anyone take notice, Clinuvel passed 1B USD?

Sláinte is táinte!


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Johnny H
post Posted: Yesterday, 12:42 PM
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Thank you to everyone for your replies. It's Saint Paddy's Day, so I have zero chance of forming an intelligent thought right now, but, I did just notice that the reported gross shorts for CUV on Friday was 125,589 shares. Wow.



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Clinuvel until my bowels release for the last time.
 
 


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