CytoDyn Receives FDA Guidance for its HIV BLA Dose Justification Report

 Company Believes All Issues Are Addressable and it Will Be Able to Continue BLA Resubmission

CMC and Non-Clinical Sections Will Be Fully Resubmitted as Early as September 2021

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, announced today that it received comments from the U.S. Food and Drug Administration (“FDA”) on the Company’s recently submitted dose justification report, an important component to the Company’s resubmission of its Biologics License Application (“BLA”) for HIV.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are encouraged by the guidance and comments received from the FDA. Our management team and regulatory advisory team are confident that we will be able to successfully address these comments, allowing the further advancement of our BLA resubmission. In our view, this is a major step forward in our BLA process.

“This is an exciting period for CytoDyn. With the continuation of the BLA resubmission, the near-term initiation of two important COVID-19 trials in Brazil, and possibly a strong clinical trial in the U.S. for COVID-19 long-haulers, the next two to three months could be transformative for the Company.”

https://www.cytodyn.com/newsroom/press-releases/detail/549/cytodyn-receives-fda-guidance-for-its-hiv-bla-dose