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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Johnny H
post Posted: Aug 21 2019, 08:09 AM
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In Reply To: Johnny H's post @ Aug 21 2019, 04:46 AM

Clarification on the press release I linked below:

I just looked it up. That language comes directly from the FDA guidance itself.

See page 5 of attached PDUFA Commitment letter (guidance and procedures for Fiscal Years 2018-2022)

I have to say that I'm pretty happy about this.
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Attached File  PDUFA_VI_FINAL_Committment_Letter.pdf ( 262.53K ) Number of downloads: 37

 




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Clinuvel until my bowels release for the last time.

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rabbitrun
post Posted: Aug 21 2019, 06:27 AM
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In Reply To: johnnytech's post @ Aug 21 2019, 06:01 AM

Whatever it takes. Move the goal posts to make your numbers look good, but approve Scenesse!

 
johnnytech
post Posted: Aug 21 2019, 06:01 AM
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In Reply To: rabbitrun's post @ Aug 21 2019, 05:38 AM

FDA is measured internally on hitting that PDUFA date. In that list of date differentials I posted earlier, it's rounded to every two weeks in the spreadsheet with a complicated time/date formula, but almost all those results are within 3 days of the rounded result anyway.

Doesn't it seem odd that they always hit the date or earlier in such a complicated team effort of evaluating a drug? Why is their miss ratio so low? Well, I read somewhere a long time ago that FDA is under high scrutiny internally based on performance metrics on hitting those dates.

The inference of this from my own conjecture is that the PDUFA extension mechanism is just a function to keep their metrics looking good. Otherwise why even bother with an extension. With the pressure to keep "fast tracked" drugs within parameters (can't keep extending priority drugs, looks bad), and crossing this with internal FDA performance metrics, I think there is a higher chance of rejection than extension. They don't want to extend our go over. Approval chances on our before PDUFA deadline.... 96%. Rejection... 3%. Extension or missed date... 1%.


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totallysour
post Posted: Aug 21 2019, 05:56 AM
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In Reply To: rabbitrun's post @ Aug 21 2019, 05:38 AM

Just checked. Drugs from that list were all approved essentially on the PDUFA date. One was ~2 weeks early. Wouldn’t get too excited but it does bode very well for Scenesse approval.


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rabbitrun
post Posted: Aug 21 2019, 05:38 AM
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In Reply To: Johnny H's post @ Aug 21 2019, 04:46 AM

So that list of companies that received extensions were approved within that extra three month window -- were any of them actually approved before the revised date?

 
seeva222
post Posted: Aug 21 2019, 04:58 AM
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In Reply To: Johnny H's post @ Aug 21 2019, 04:46 AM

Logically, you wouldn’t think they’d extend a deadline on something they didn’t anticipate approving. Agencies aren’t always logical.

 


Johnny H
post Posted: Aug 21 2019, 04:46 AM
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I did a quick google search of PDUFA extensions to see how common it is, and what the outcome generally is.

The first 3 pages of results led me to:

Orilissa

Solriamfetol

Inbrija

Zulresso

Ruxolitinib

Selinexor, and

Zerenex.

All received a 3 month PDUFA extension, and then were later approved in that 3 month window(1st cycle approval, no CRL).

In addition, Xeris Pharmaceuticals received a 3 month PDUFA extension for the FDA review of Gvoke. New PDUFA date is September 10th, 2019. The language in their investor press release is interesting:
https://www.globenewswire.com/news-release/...-for-Gvoke.html

"According to FDA’s current PDUFA Performance Goals, an FDA decision to extend the review period typically is limited to situations where review of the new information could address an outstanding issue(s) and lead to approval in the current review cycle."


Perhaps we're in an even better position for approval than I had previously thought (in my opinion, chances for approval were already above 90%).

Does anyone know of a drug that received a 3 month PDUFA extension and then was later denied? I haven't found one yet. I'll keep looking.



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Clinuvel until my bowels release for the last time.

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seeva222
post Posted: Aug 20 2019, 11:18 PM
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I predicted Aug 21 as liftoff date. Hope it holds true

 
Farleap11
post Posted: Aug 20 2019, 11:05 PM
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A couple more Mutual and Institutional Funds have been added to the major holders list as from 31 July 2019.

https://www.barrons.com/quote/stock/au/xasx/cuv


 
LevelHeaded2000
post Posted: Aug 20 2019, 10:08 PM
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In Reply To: Clinhope's post @ Aug 20 2019, 09:30 PM

You may want to check out bitcoin or gold forums. That is usually where there is lots of cash activism.

 
 


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