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

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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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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post Posted: Yesterday, 08:43 PM
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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 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

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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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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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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.

Clinuvel until my bowels release for the last time.
post Posted: Yesterday, 10:42 AM
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In Reply To: polyphemus's post @ Yesterday, 09:58 AM

Thanks. I saw 17 transactions on my NAB brokerage account between the hours of 17:00pm and 07.39am and all of them were for 43,139 shares each with SXXT. May be an error or repeat of the same transaction. Not sure.

Also for sure about 1.2m shares came on the sell side during CSPA 4.00pm

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post Posted: Yesterday, 09:58 AM
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In Reply To: Johnny H's post @ Yesterday, 08:48 AM

Friday - ASX crossed at 16:10:44 Couple of large specials were then book on CHI-X for 72,810 - finally a couple of late Portfolio transactions occurred on ASX and CHI-X.
If I were showing day traded volume in a system I would cut of at the listing exchanges close to have a more reflective day change for price and volume. That's just a philosophical view point not a rule. But there is no reason why these could not be put into daily volume calculations, however there is no guarantee the price transacted at will be similar to the market. Special Transactions can be like placements at pre-agreed prices. CHI-X market also trades a little later than ASX random post 4:10pm, to 4:12pm fixed time for clean up purpose on Brokers day books.

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