Looks like the FDA, for whatever reason, may have
Post# of 148293
Quote:The Type A Meeting is tomorrow, September 8.
Looks like the FDA, for whatever reason, may have “changed it’s position” on some of their WRO responses. This necessitated an immediate issuance for a Type A meeting, Sept 9th.
I understand an appreciate the logic of your thesis, but CytoDyn will not receive a BLA approval tomorrow, and they will not receive it at the end of the Multidisciplinary Review, which is not less than 30 days from when CytoDyn provides the FDA with the entire revised BLA submission.