Replies to post #81528 on Cytodyn Inc (CYDY)

[Chuckles759]

Good question on how long the FDA can stall the process.

Here's a graphic showing the normal 10-month process. The 6-month "fast track" is shown in red text on the graphic.



This came from briefings found here:

"Bootcamp" presentation:
The Biologic License Application (BLA) Process

FDA Link:
CDER 21st Century Review Process

[ohm20]

74 days to either accept or reject. Once interim COVID-19 trial results are released and the spotlight is on Cytodyn, HIV BLA rejection without extremely good cause would blow up in the FDA's face. The last thing the FDA wants is an investigation into how the FDA held back a no SAE, no resistance HIV drug for years.