Posted by Michael Wonder on 02 Dec 2021
CytoDyn submits CMC (manufacturing) section of HIV BLA to FDA under previously authorised rolling review; last (clinical) section will complete full BLA submission
1 December 2021 - FDA may initiate review of this biologics license application under previous rolling review granted to CytoDyn.
CytoDyn today announced it has completed submission of all the major sections of CMC modules to the FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week.
