CYDY - CytoDyn submits the first section of HIV BLA to FDA under rolling review

CytoDyn (OTCQB:CYDY) has initiated the resubmission of its Biologics License Application (BLA) for HIV under rolling review consistent with guidance from the FDA. The resubmission will include non-clinical and CMC sections during November, followed by submission of the clinical section in Q1 of 2022. CytoDyn (OTCQB:CYDY) will also file for expanded access use of leronlimab for a fee to MDR HIV patients who might need leronlimab urgently, possibly as soon as next week.

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CytoDyn submits the first section of HIV BLA to FDA under rolling review