CytoDyn Submits CMC (Manufacturing) Section of HIV BLA to FDA Under Previously Authorized Rolling Review; Last (Clinical) Section Will Complete Full BLA Submission
CYTODYN INC (CYDY)
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ir.cytodyn.com
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Source: Business Wire
CMC section is of great importance to our other potential approvals, including potential EUA for COVID-19 and Breakthrough Designation Therapy in CancerFDA may initiate review of this BLA under previous rolling review granted to CytoDyn VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. CMC is a critical part of CytoDyn’s Biologics License Application (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted.Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Office
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CYDY
Sec Filings
- 4/16/24 - Form 424B3
- 4/16/24 - Form 424B3
- 4/15/24 - Form 10-Q
- CYDY's page on the SEC website