Chuckles759 on another board recently posted this

Quote:

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For anyone wanting to understand the FDA's CDER process and the timeline they try to adhere to for NDA/BLA applications, I invite them to consult the briefing the FDA provides on their website.

https://www.fda.gov/media/78941/download

Going to the first page of Appendix A there is a framework of dates. See below for a copy of this one page as I have posted it here multiple times and some may have "misplaced" it.

Even if there is confusion concerning on what day the FDA considered the BLA submission "complete" we can either take April 27, 2020 or May 11, 2020. We're either waiting for CytoDyn to announce something they've heard from the FDA, or CytoDyn is still waiting on the FDA. Time will tell.

PDUFA announcement date:
27Apr20 + 74days = 11Jul20
11May20 + 74days = 24Jul20

Also, in the CDER timeline is the notification of RTF (Refusal to File) which would have been by Day 60.

RTF notification:
27Apr20 + 60days = 26Jun20
11May20 + 60days = 10Jul20

The salient steps here are detailed in Steps 8 through 13. For complete information on what leads up to these dates, consult the FDA link from above and refer to Pages 19 through 31.

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