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CUV, CLINUVEL PHARMACEUTICALS LIMITED
macgyver
post Posted: Oct 8 2018, 04:08 PM
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In Reply To: LevelHeaded2000's post @ Oct 8 2018, 03:53 PM

Its a problem I have with the current strategy. Regardless of whether Clinuvel obtains FDA approval, they still have work to do in Europe. This intense singular focus on the FDA blindsides Clinuvel to anything else. FDA approval is not contingent on keeping a low profile across the globe. It's approved in Europe for God's sake!

I understand meeting requirements to list on the NASDAQ, but like I mentioned before, theres a whole lot of money burning a hole in Clinuvel's bank account that needs to be put to work. Otherwise I'm going to give my crusty old friend Carl Ichan a call and get him down to the AGM to agitate for change!!!


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LevelHeaded2000
post Posted: Oct 8 2018, 03:53 PM
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When is it expected that we will hear back from the FDA? To me, the most important thing is that Clinuvel begins expansion on other indications. It can, and should, pursue other indications.


Regardless of the FDA approval it needs to expand its portfolio of indications in Europe. So, hopefully they are committed to the 2019 Q1 trial for VP. And, hopefully they begin to trial other indications more aggressively and work on things in parallel.

Regarding the FDA, it is an entirely different organization than it was back in the EpiTan days. Even if there is no priority review I do not think we should assume the FDA is yanking us around. Even compared to Europe, the FDA will have a wealth of information about the drug in real-life experience. The most important numbers, IMO, is 1) The drug is extremely safe 2) It has 98% continuance rate. The latter being important especially because it is not easy to take the drug. Patients need to drive distances to the specialty centers, They need to do medical tests. They need it implanted into their skin and may even get built up scar tissue at the implant sites, etc.

The primary weakness with the NDA is that it's primary end-point is weak. It is weak due to the disease type and the built-up lifelong habits of the patience. So, that is the real only weakness. And, that is why the 98% continuance rate is so important. It shows that even if it could not be fully demonstrated in the primary end-point of the trial that there is in-fact huge patient quality of life benefits. Otherwise there would not be a 98% continuance rate especially given the hassle to continue using it. I mean, there is at least one patient who flies to europe from the USA. Who would sit on a plane for 12 hours to take an expensive drug unless it let them be in the sun more?


This is likely why the FDA asked for more data about the last 6 months of patients taking the drug to view the patient continuance rate. It shows that they are considering that data and they find that data important.



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Dr Wally
post Posted: Oct 8 2018, 03:04 PM
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In Reply To: johnnytech's post @ Oct 8 2018, 11:18 AM

“At best, they have been told no priority and NDA accepted and filled and waiting pdufa.”

100%...... Im praying for it but it’s a certainty (always has been) that Clinuvel won’t be seeing the FDA grant their Priority Review for Scenesse NDA. FDA are going to happily drag this out for as long as they legally can, a la Europea. 2020 sometime will be the best we can hope for (Scenesse approval) I feel, barring a miracle. 🙏🏾

Not having FDA PR granted, is in no way indicative of Scenesses approvability (the one certainty in this never ending journey is that Scenesse WILL eventually be approved) it’s just proof that the regulator deplores the drug because it stimulates a safe, photo protective, therapeutic **tan.**





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Any price pre FDA approval will be seen as an absolute bargain within 2-3 years. 🙂

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macgyver
post Posted: Oct 8 2018, 02:22 PM
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In Reply To: LevelHeaded2000's post @ Oct 8 2018, 01:41 PM

Including the requisite increase in share price of course Mr LevelHeaded....

 
LevelHeaded2000
post Posted: Oct 8 2018, 01:41 PM
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In Reply To: Johnny H's post @ Oct 8 2018, 09:25 AM

I think this is will be a quiet period for a while. We will know when the FDA accepts the New Drug Application. I think Clinuvel will begin to attend more conferences and basically market the company more, which has been demonstrated in the last month. This is good to raise visibility of the company. After this, the primary new news over the next year will be new indications begin trialing and the approval by the FDA.

Other than the NDA acceptance I imagine the next 6 months will be rather quiet and will be just filled with marketing the company via investor presentations to raise awareness of the company to the investor class.


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johnnytech
post Posted: Oct 8 2018, 11:18 AM
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The Oct 4th presentation to the Europe Biotech conference is appended to today's Oct 8th announcement. It's uninteresting as others have pointed out, but some of the FDA language has changed nuance. It says the next step for FDA is waiting for an assigned PDUFA date and no longer is there any language about priority review.

We have been let to believe the next step is returning answers to the latest Sept inquiries, and the chairman's letter dated 3 days ago mentioned something about that as well. They PR language is is also lacking from his letter.

I don't exactly think investor slides is good source material, so this is mostly anecdotal observation. At best, they have been told no priority and NDA accepted and filled and waiting pdufa. At worst, no change.


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Clinhope
post Posted: Oct 8 2018, 09:59 AM
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Fantastic idea investek, i gave my details a bit late but when i recieve it ill make a donation.



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Member of the “ALL-IN” club 2018.

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Johnny H
post Posted: Oct 8 2018, 09:25 AM
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In Reply To: ajshare's post @ Oct 8 2018, 09:00 AM

Interesting. They have their boiler plate "Forward looking statements" on the ASX release.
And then they have a newer "Forward looking statements" in the presentation slide. I'm not going to read too much into it, but I hope it means some good news on the horizon.



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Clinuvel until my bowels release for the last time.

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ajshare
post Posted: Oct 8 2018, 09:00 AM
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new name....

Daniela Schaefer
VP Global Business Development

 
ajshare
post Posted: Oct 8 2018, 09:00 AM
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SACHS 18TH BIOTECH IN EUROPE FORUM PRESENTATION

Nothing new..
https://www.asx.com.au/asxpdf/20181008/pdf/...1lz45q14r6h.pdf


 
 


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