Cytodyn Inc (CYDY)

[justdafactss]

Seems the CALENDARS are doing all the talking.

No FDA PDUFA date set for Cytodyn. Best I can make of it, the BLA was not submitted or if submitted the FDA found it to be incomplete.

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/2020/07/02/2056782/0/en/CytoDyn-Releases-Mechanism-of-Action-Animation-for-Leronlimab-in-Immuno-Oncology.html