“ VANCOUVER, Washington, May 13, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today confirmed on May 11, 2020, it submitted all remaining parts of the Company’s Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients to the U.S. Food and Drug Administration (“FDA”). Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review.

As a next step, the FDA will start reviewing the BLA for completeness and will make a filing decision. After the BLA submission is deemed completed, the FDA assigns a Prescription Drug User Fee Act (PDUFA) goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation, if granted, means the FDA’s goal is to take action on the application within six months of receipt (compared with 10 months under standard review).”