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CUV, CLINUVEL PHARMACEUTICALS LIMITED
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: 63

 



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johnnytech
post Posted: Yesterday, 07:26 AM
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In Reply To: Johnny H's post @ Yesterday, 02:48 AM

Your first point bears repeating just in case it's not clear to everyone. The FDA might respond on October 9th or early, and as late as October 11th (Friday), and still meet their internal metrics. But they could also miss the date and it might be as late as December 10th or January 10... just like the two outlier cases from 2017.

As far as extensions for changing the PDUFA date again, what Johnny H found was gold and I didn't know that previously, there are no more extensions to be had. They have to approve or reject and the clock is ticking. It almost makes me wonder if PW purposely left them low-hanging fruit to find, (to give the FDA fodder for an extension), because how can you screw up a simple response about a manufacturing question 5 months ago when you were given the question 9 months ago. It's almost as if he planned it. If he was that calculating, kudos to him.


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Johnny H
post Posted: Yesterday, 03:52 AM
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In Reply To: seeva222's post @ Yesterday, 03:07 AM

This is more in response to Wolgen's statement in the newsletter:

"At this stage an Advisory Committee is not planned but again, the FDA reserves – at this late stage of the review – its right to call an Advisory Committee if it concludes that a further independent opinion is needed."

He's right. The FDA has the right to call AdComm, up until August 25th... this Sunday.



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Clinuvel until my bowels release for the last time.
 
seeva222
post Posted: Yesterday, 03:07 AM
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In Reply To: Johnny H's post @ Yesterday, 02:48 AM

They didn’t announce it six weeks prior to the first PDUFA date. Wouldn’t that time have passed?

“The FDA had previously advised that it does not intend to hold an advisory committee meeting during the scientific review of the SCENESSE® NDA.”

 
Johnny H
post Posted: Yesterday, 02:50 AM
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In Reply To: seeva222's post @ Yesterday, 02:46 AM

I found some CRLs from back in 2010-2011, but that was before the FDA guidance was issued.

I can't find a single instance of a CRL under current PDUFA VI guidance.



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Clinuvel until my bowels release for the last time.

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Johnny H
post Posted: Yesterday, 02:48 AM
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So, there is a lot of talk about AdComs and PDUFA extensions. I highly recommend that anyone interested in these matters read the FDA guidance I posted below. I'm only about halfway through it, but there is a bunch of useful information on how this process works.


Among the useful information I've come across so far:

-The PDUFA date can be extended once, and only once. (yes, the FDA can miss their own target date if they have not completed the review, but they cannot extend the date again)

-The FDA can announce an Advisory Committee Meeting up to 2 months before the PDUFA date (standard review), or 6 weeks before the PDUFA date (priority review).

As this pertains to Clinuvel, it means that the FDA can announce an Advisory Committee meeting any time up until.... this Sunday. After that, we're out of the woods (not that I am particularly concerned about it; just one less thing to worry about)

There's some stuff about the Signatory Authority in the guidance as well, but I haven't read and digested that part yet.



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Clinuvel until my bowels release for the last time.

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seeva222
post Posted: Yesterday, 02:46 AM
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In Reply To: Johnny H's post @ Aug 21 2019, 04:46 AM

I looked at a few more. All were approved.


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stmccallum
post Posted: Yesterday, 01:08 AM
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In Reply To: royco's post @ Aug 21 2019, 04:22 PM

The FDA can send a draft label to the sponsor right up until the last days before the PDUFA and say take it or leave it.
Not the best way to negotiate with a sponsor in good faith but it can happen. Also not a way to have meaningful discussions on any post marketing studies they may want the sponsor to run.

But anything is possible right up until the PDUFA date.

Just look at what happened to Vascepa initially given priority review without the need for an Ad Com, PDUFA date of July to now we need an ad com earliest we can accommodate is November..... new PDUFA end of Dec.....oh well so much for that priority review....


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royco
post Posted: Aug 21 2019, 04:22 PM
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What I dont get is the time the fda leaves cuv to put in place the labelling and follow on requirements..

Previously these were supposed to be released no later then April with a pdufa set for July 8th.
Now early September for early October pdufa.

1 month compared to 3 months.

The latest newletter says cuv is unaware but expecting an Ema copy of draconian follow up.
How can they put this in place within 20 working days? Hire, train peiple and document what is not an exact copy and paste of eu follow up.
After all this is clinuvel and iT is in a virtual timezone as we know.
Probably the mass impact of scenesse is causing a wobble in the space time continuüm when close enough to market gatekeepers.

If really eu-similar I would count on 3 to six months needed before commercial roll out start in the usa.
My guess would be this has to be audited by the fda prior to pdufa.
Hence further delayed pdufa.
Then pdufa met within 3 days and perfect stats.

First us sales around half 2020??

Other option: eventually very little follow on misery required since the fda dont want to put out a “bad” example of how iT approves drugs(not).
Other option: cuv u turn and strategy change. Eg. Us partnership, take over, Nasdaq entity, prior to the September release.
And Many more options for sure!



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Ἀρτεμίσιον

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