Cytodyn Inc (CYDY)

[justdafactss]

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA. The Company filed a request for Priority Review designation for its BLA to shorten the FDA’s review time from 10 to 6 months, an FDA goal for BLA applications given Priority Review designation.
https://www.globenewswire.com/news-release/2020/06/08/2044758/0/en/CytoDyn-Receives-BLA-Acknowledgment-Letter-From-the-FDA.html

No PDUFA goal date set for CYDY-


https://www.fdatracker.com/fda-calendar/

Listings shown from July 2020 to April 2021-

https://www.biopharmcatalyst.com/calendars/pdufa-calendar