Factual quotes from a very good summary:

"Right now in my opinion the odds are almost certain of a BTD approval. One BTD is worth billions and the company seems resolute on getting 2 BTD’s which would put valuation well over $10 billion. "

"It’s important for shareholders to realize why the BLA was delayed: initially, the FDA only wanted the safety data from 50 patients, when the FDA asked for data from all 595 patients in the ongoing CD03 trial in BLA format this created much more work (this is a manual procedure) — The FDA was essentially sitting quietly on the sidelines, happy with the data but wanted 595 instead of 50 patients.

Investors should keep in mind that the company was supposed to have filed the completed BLA originally by the end of December, with the safety data already on file for months. The timing of the clinical part was for all practical purposes done, with only the CMC (Chemistry, Manufacturing, & Controls) stability studies remaining.

Indirectly the FDA is helping CytoDyn by not making them do another trial."

https://insiderfinancial.com/investors-fleein...al/179575/