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ClosetInvestor

12/11/21 11:16 PM

#196523 RE: The Dark KnaDDir #196520

“Do we know on what date the company or its CRO Amarex received the RTF letter from the FDA? On the letter from the court filings there is no date on it.”

No and that’s a good question. You could try an FOIA to the FDA but I’m sure they’ll deny the request because the HIV BLA and RTF is part of an ongoing investigation.
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justdafactss

12/12/21 1:23 PM

#196559 RE: The Dark KnaDDir #196520

In July 2020, the Company received a Refusal to File letter from the FDA regarding its BLA filing requesting additional information.
https://www.sec.gov/Archives/edgar/data/0001175680/000155837021004250/tmb-20210228x10q.htm

I would like to know the specific date for BLA 761144 too.


One thing is certain tho, BLA 761145 is signed NICOLE J GORMLEY
05/01/2020 12:55:59 PM

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761145Orig1s000ltr.pdf