An additional two links from the FDA that describe both categories:

www.fda.gov/.../fast-track

www.fda.gov/.../priority-review

Yes. But please do not confuse "fast track" and "Priority Review" as part of the FDA's CDER process for BLAs. Fast Track: https://en.wikipedia.org/wiki/Fast_track_(FDA) Priority Review: https://en.wikipedia.org/wiki/Priority_review Two different processes, timelines, and approvals. The "Priority Review" designation is the most important at this time since it is what the FDA uses to determine the PDUFA date from the time of BLA acceptance. For this BLA, CytoDyn's was accepted on 27Apr20 with a data follow up on 11May20. The Day 74 date, or PDUFA date notification date to CytoDyn, will be by 11Jul20. A very minor overall point to make for this very critical juncture but, none the less, a point of accuracy. Of course, in times of crisis any of these dates can be accelerated.

I would also like to point out that your article is a wonderful write-up of the current status for this exciting announcement. Very good work. Thank you.

Thank you for the reply. I understand the CDER process. But there is no other confirmation of a "Priority Review" designation - that would have come by Day 60 (June 26) directly to CytoDyn. The PDUFA date is by Day 74 (July 11). Both of these dates are the same for "Priority Review" or "Standard Review". Maybe there is some misunderstanding about what "fast track" and "Priority Review" indicate here. The CDER "Priority Review" designation would be the one which allows the PDUFA date to be in the August or September time-frame. Thank you ---late add--- The CDER process information from the FDA website: https://www.fda.gov/media/78941/download ---late add---

A question to the author: Can you provide information to your statement "It filed its BLA in April and is widely expected to receive a PDUFA date in August or September because it has fast track and rolling review."?

Specifically the "fast track" designation.

Thank you