Happy to be corrected, but here is my understandin

Happy to be corrected, but here is my understanding of the process.

Also, here is a link if you'd like to research this on your own:
https://www.fda.gov/media/78941/download


- FDA may issue a RTF 60 days after BLA submission
- Otherwise, if a BLA is accepted, a PDUFA date may be provided in 74 days
- CytoDyn received a RTF 60 days after their corrected filing

- A RTF includes a list of deficiencies (which we know)
- After receiving a RTF, a company can request a Type A Meeting
- A Type A Meeting allows questions to be asked regarding the deficiencies
- The goal is to correct issues BEFORE a re-submission of the BLA

- The Type A Meeting request form includes a list of CytoDyn questions
- The FDA responded by saying that the meeting would be WRO (Written Response Only)
- The FDA stated they would respond (in writing) to CytoDyn's questions by September 4
- That response may, or may not, have already happened (we'll learn on Wednesday)

- The FDA's WRO may completely answer CytoDyn's questions
- If so, CytoDyn can perfect the BLA and resubmit to the FDA

- Alternatively, CytoDyn may ask more questions if further clarification is necessary

- Either way, CytoDyn must resubmit the BLA and the clock is completely reset
- The FDA will have another 60 days to issue a RTF based on the re-submission
- Otherwise, if the revised BLA is accepted, a PDUFA date may be provided in 74 days

- Based on Fast Track status, it can take 6 months after the issuance of a PDUFA date to learn if the BLA is approved

So, all told, it can take up to ~8 months for BLA approval after CytoDyn resubmits the revised BLA.