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Posted On: 08/20/2020 7:12:15 AM
Post# of 148983
Quote:
Announced today it will conduct its Type A meeting in writing in lieu of a teleconference with the U.S. Food and Drug Administration (FDA). The FDA has agreed to respond to the Company’s questions by September 4, 2020 concerning the additional information the FDA requires to resubmit the Biologics License Application (BLA) for leronlimab as a combination therapy for HIV.
The good news: We will get an answer soon (September 4).
The bad news: There will be only one shot to the goal. No back and forth.
The interpretation: Either the FDA thinks that the BLA documentation deficiencies are simpe to overcome and can be resolved by a simple delivery of documents/clarifications/additions to address their concerns and accept or reject on September 4th (my birthday
) or they are planning on continuing giving us the "slow motion" treatment. We will find out soon which one it is (in 14 days, to be more precise).
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