Posted by Michael Wonder on 01 Jun 2020
CytoDyn files request with FDA for priority review of BLA for first approval
1 June 2020 - If granted, the FDA is expected to take action on the Company’s BLA within six months.
CytoDyn announced today that it has filed with the U.S. FDA a request seeking priority review designation for the Company’s biologics license application for leronlimab as a combination therapy for HIV indication.
The Company filed its application for leronlimab as a combination therapy for highly treatment experienced HIV patients with the FDA on 27 April 2020 and submitted additional FDA requested clinical datasets on 11 May 2020.
