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post Posted: Apr 29 2019, 01:07 PM
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In Reply To: Verharven's post @ Apr 29 2019, 12:56 PM

Some stats on 2018...any day now????

PDUFA Dates, AdComms and Approvals – 2018 So Far
Posted on March 14, 2018 by Mark Senak

There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular entities (NMEs), but also for generic approvals (1027). And among those approvals, there were a number of “firsts” – such as first gene therapy and the first CAR-T therapies. In addition there were a significant number of approvals in oncology. A lot happened last year. That means a lot of eyes turn to this year to see what kind of year it is going to be in 2018.

So how are we doing? There are a few places to look when you are making that assessment that are kind of surrogate markers to tell us how things are going. First, of course, there would be the NME approvals. By the end of February this year, FDA had approved only 4 NMEs, which might sound discouraging, but in fact, it is only one less than was approved by the same time last year. There is still a lot of time for a lot to happen in 2018.

Another place to look is at PDUFA dates, and in doing so there is perhaps reason for cheer. During January and February there were 15 PDUFA dates, 3 of which resulted in Complete Response Letters and 12 of which were approvals, some of which not only occurred early, but very early. At least three of these were approved in December 2017, two months before the PDUFA date. Of the approvals during the first two months, 9 of them were NDAs and 6 were sNDAs.

And finally, if we take into consideration the activity among advisory committees – last year there was only 1 advisory committee meeting held during the January/February period to consider an NDA for a new drug. During the entire year by my count there were 23 such meetings. By contrast, during the January/February time period this year there were 5 advisory committee meetings held to consider NDAs and there have been 10 meetings scheduled so far this year, with more surely to come, particularly with the increase of drugs that have priority review.

Back to PDUFA, for the future, right now by my count, I am currently counting 60 more decision dates for 2018, 41 of which are for NDAs and the balance are sNDAs, and of course, there are more to come. Five of these involve product NDAs in oncology, two of which FDA have already acted upon away before their actual PDUFA dates. There are also five in cardiovascular, two in antimicrobial and six in pain.

In short, at this early juncture, judging by a look at these “surrogate endpoints” it would seem that there is a good chance this year will not be a slacker in terms of progress in approvals overall or in advances in major disease areas.

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post Posted: Apr 29 2019, 12:56 PM
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In Reply To: Hamster72's post @ Apr 29 2019, 12:48 PM

A nice article on FDA approval times for drugs given the 'fast lane' designation under 4 different types of programs so includes priority review which is what Scenesse has. Point of note is that even though the PDUFA date is given as 8 months from the submission date for a PR (so 6 months once the day 74 letter has been generated which we got in Jan) this isn't set in stone and the second graph (Figure 2) I've copied below is the one of interest showing the median time of approval for Priority Review (PR - in green) is about 240 days (8 months) which is bang on the expected timeframe, but there is a range of about 90 days to 620 days though maybe a trend for this getting into a narrower band for all approvals with each year especially now in 2018/2019 with the push for even faster approvals..

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post Posted: Apr 29 2019, 12:48 PM
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I'm a novice on FDA approval timelines. Can anyone with knowledge help us understand expectations on a FDA decision? Would it be normal to not receive an answer until July, or is it probable we will hear a final decision before? Also, is it a positive that we are still here 60 days out without a decision or Clinuvel withdrawal, or is this all completely normal?

Thank you in advance.

Dr Wally is not a doctor at all. He's a dentist.
Dr Wally
post Posted: Apr 28 2019, 11:47 PM
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In Reply To: Dr Wally's post @ Apr 28 2019, 07:52 PM

ironically might make more sense 🤓

Dr Wally
post Posted: Apr 28 2019, 11:47 PM
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In Reply To: Dr Wally's post @ Apr 28 2019, 07:52 PM

ironically might make more sense 🤓

Dr Wally
post Posted: Apr 28 2019, 07:52 PM
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In Reply To: johnnytech's post @ Apr 28 2019, 02:11 AM

It p1sses me off when I think about the years that have been wasted frustratingly because of the very thing that lies at the heart of this cancer preventative drugs certain success: EUMelanin. Aka a photo protective “tan”.

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Johnny H
post Posted: Apr 28 2019, 07:25 PM
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In Reply To: juxtaposer's post @ Apr 28 2019, 01:57 PM

The thing that is absolutely stopping me: quality control.

Counterfeit is exactly that: counterfeit. There are plenty of companies on the internet selling Chinese made knock-off peptides for $3 per milligram with a claim of 99.9% purity.

To put that into perspective, one of the most reputable peptide manufactures in the United States manufactures NDP-MSH/afamelanotide and sells it for legitimate scientific research. Each batch of peptides is delivered with an audited QC summary sheet including:
-2 reverse phase HPLC profiles to verify purity
-mass spectrometry to verify molecular weight (performed and certified by an independent 3rd party)
-amino acid analysis to verify composition

They are the absolute best in the business, and despite all of their expertise, their batches of afamelanotide/NDP-MSH are only about 96% guaranteed purity.. And guess how much they charge for 10 milligrams of NDP-MSH/afamelanotide?


The websites selling the knock-offs are obviously lying about what they're selling. If they're lying about that, what else are they lying about? Are they selling rat poison? It's just not worth the risk.

Of course, I can think of an easy way for the FDA to eliminate that risk if they want to....

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Clinuvel until my bowels release for the last time.

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post Posted: Apr 28 2019, 01:57 PM
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In Reply To: Dr Wally's post @ Apr 27 2019, 08:38 PM

"What’s stopping you?"
I'm not prepared to go down the online knockoff line.Besides that Clinuvel picture on Twitter recently of a purple/blue/grey lotion
from their Singapore office during #PorphyriaAwarenessWeek sure looks interesting.
Porphyria Awareness Week

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post Posted: Apr 28 2019, 01:40 PM
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So the fun is about to start.

> Cash receipts numbers next week. If early payments are coming in they could surprise.
> 60 day countdown starts May 7th, prices look to start rising at this point.
> June ASX rebalance on the way
> July 7 PDUFA
> July cash receipts. This should be a strong quarter.

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post Posted: Apr 28 2019, 12:39 PM
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In Reply To: Clinhope's post @ Apr 28 2019, 09:36 AM

Thanks Clinhope have had health issues myself last couple of years and live for moment now myself dont need CUV $'s yet but will sell some when I do although would love to hang onto some untll a 20 bagger or $80

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