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DaveV-1

06/23/20 1:11 AM

#86547 RE: justdafactss #86542

The FDA does not publicly publish a list of BLA applications submitted for assessment. The FDA makes filing determinations for BLAs or they inform the applicant of the refusal to file in an official correspondence to the applicant.

Cytodyn did have a press release 8 June stating "the U.S. Food and Drug Administration (FDA) advised the Company, subject to its ongoing review, it could receive its “PDUFA date” on July 10, 2020" or the filing determination date.
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ohm20

06/23/20 5:03 AM

#86554 RE: justdafactss #86542

It's common knowledge that the FDA does not announce that.
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bwolfy2002

06/23/20 3:14 PM

#86717 RE: justdafactss #86542

That is true for every company that has EVER filed a BLA FOR EVERY BLA they have EVER filed... so I don’t see your point here.