Replies to post #92032 on Cytodyn Inc (CYDY)

[Rtime]

Excellent point MunchMeat42 !!

[Chuckles759]

---late add---
Borel Fields - hahaha !! wicked minds think alike !!

Not sure about 8K filing deadlines after receiving info from FDA.
---late add---

Even NP himself said in the DrBeen interview that CytoDyn made the BLA submission on 27Apr20 and that the FDA said "No, it's not complete"...CytoDyn scrambles and submits additional data on 11May20.

Which date is the REAL SUBMISSION DATE plus 74 days? And the CDER BLA process documents say "by" a certain date...which could also mean "before but no later than".

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

So, two things of many could be happening here. NP has the BLA announcement of the PDUFA date, or he's been sitting on the RTF announcement. Also, CytoDyn is notified confidentially of the FDA rulings - it's not a public announcement from the FDA. So, CytoDyn is the only one making the announcement of any of this.

Any bets on which date? Which announcement?

[Borel Fields]

When did the FDA start the clock? April 27 with the main filing or May 11 when additional data tables were provided?

If April 27, Saturday is 74 days and the FDA has to respond.

If May 11, Saturday is 60 days, and there is an optional FDA response (per my reading) only in case of really good news (priority review) or really bad news (refuse to file).

All just my understanding.