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justdafactss

07/10/20 11:07 PM

#92950 RE: justdafactss #92941

Uh OHHH! PDUFA Agenda Listing to March 31, 2021

CYDY nowhere to be found-



https://www.fdatracker.com/fda-calendar/

Scooter McCabe

07/10/20 11:09 PM

#92951 RE: justdafactss #92941

Myth Busted Fake Calendar.

Quick and simple you have to pay to see what is actually on the calendar.

29 bucks a month to some company that runs a site not actually attached to the FDA.

Here is the link for having to pay to see what's on the Calendar:

https://www.fdatracker.com/membership-account/membership-levels/


Here is a link showing it has nothing to do with the FDA:

https://www.fdatracker.com/about/


MYTH BUSTED

Chuckles759

07/10/20 11:58 PM

#92960 RE: justdafactss #92941

Tsk...Tsk...Tsk....

Shameful analysis of how this calendar works. These PDUFA dates listed in the calendar shown are the ACTUAL PDUFA dates - not the date they were announced.

I thought everyone here understood that CytoDyn is awaiting ANNOUNCEMENT of the future PDUFA date, which isn't shown on this calendar if I hadn't mentioned that already, at which time the ACTUAL PDUFA date will then be known and can be placed on the calendar.

If one were to read the text of the underlying documents for each PDUFA date on this calendar they would find that the announcement date was many months prior to the date marked on the calendar.

For instance, on July 23, 2020 the company ANIP ANI Pharmaceuticals, Inc. will hopefully have their PDUFA date granted on that day. The actual announcement was way back on April 13, 2020 as evidenced in the link provide on that calendar date (https://www.prnewswire.com/news-releases/ani-announces-fda-acceptance-of-supplemental-filing-for-cortrophin-gel-80-uml-301039194.html).

Oh, and I wouldn't trust non-authorative .COM websites for PDUFA announcements because they are not be maintained by the FDA and may not be updated regularly since they rely upon either press releases from the applicant or an SEC filing to manually create the calendar item. Since the FDA only notifies the applicant and not the general public about these approvals, it would make sense to hear it from the only entity who would know this...meaning CytoDyn in this instance.

So, I think this one has now been TRIPLE DOG DEBUNKED.


SNICKERING