CytoDyn Inc CEO Nader Pourhassan joined Proactive to speak about the FDA’s acceptance of its revised “rolling review” timeline for the upcoming resubmission of its biologics license application for leronlimab as a combination therapy for highly treatment-experienced HIV patients.
Pourhassan says it expects the non-clinical and CMC (chemistry, manufacturing and controls) sections of the BLA to be resubmitted to the FDA in November 2021. The clinical section of the BLA is anticipated to be completed and resubmitted during the first quarter of calendar 2022.
source