Posted by Michael Wonder on 29 Oct 2021
CytoDyn announces FDA accepts revised rolling review timeline for resubmission of its BLA
28 October 2021 - Management expects the non-clinical and CMC sections of the BLA to be resubmitted to FDA in November.
CytoDyn announced today the U.S. FDA has accepted the Company’s revised rolling review timeline for the Company’s upcoming resubmission of its biologics license application for leronlimab as a combination therapy for highly treatment experienced HIV patients.
