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post Posted: Yesterday, 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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post Posted: Yesterday, 02:57 PM
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In Reply To: seeva222's post @ Aug 20 2019, 11:18 PM

I'm not sure when lift off will occur, though around this week is as good a guess as any.
I did decide today though, that I think we have seen the bottom of this dip and so bought up a few thousand for the first time in 6 months. I didn't get the very bottom, but I'm satisfied, a few more above $28.80 (when/if it gets there) and I'm done.

This pull-back and the 3 month delay cost me a lot of money on paper, I thought it'd annoy my wife too, but she just quipped back:
"Didn't you say, when they gave the first approval date, that we should add half a year of Clinuvel time? Seems like it's ahead of schedule"

So I've felt no stress the last few months as the price dropped, CUV is doing exactly what anyone who has been around more than 4 years is used to.

I'll just buy the dip... again GLTAH

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post Posted: Yesterday, 08:31 AM
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In Reply To: LevelHeaded2000's post @ Aug 20 2019, 10:08 PM

I get your point but I’m just trying to get the attention of people that maybe aren’t as interested in this than the usual crowd.

Echo chambers are the death of truth.

Member of the “ALL-IN” club 2018.

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Johnny H
post Posted: Yesterday, 08:09 AM
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In Reply To: Johnny H's post @ Yesterday, 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.
Attached thumbnail(s)
Attached Image


Attached File(s)
Attached File  PDUFA_VI_FINAL_Committment_Letter.pdf ( 262.53K ) Number of downloads: 25


Clinuvel until my bowels release for the last time.

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post Posted: Yesterday, 06:27 AM
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In Reply To: johnnytech's post @ Yesterday, 06:01 AM

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

post Posted: Yesterday, 06:01 AM
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In Reply To: rabbitrun's post @ Yesterday, 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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post Posted: Yesterday, 05:56 AM
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In Reply To: rabbitrun's post @ Yesterday, 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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post Posted: Yesterday, 05:38 AM
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In Reply To: Johnny H's post @ Yesterday, 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?

post Posted: Yesterday, 04:58 AM
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In Reply To: Johnny H's post @ Yesterday, 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: Yesterday, 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:






Selinexor, and


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:

"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.

Clinuvel until my bowels release for the last time.

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