Here is exactly what was said. It was completed an

Here is exactly what was said. It was completed and submitted and the FDA didn't consider it complete because they wanted a different setup for the data sets.

That the FDA changed it's mind makes no difference to it originally being completed and submitted.

April 27th

Quote:

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CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients

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May 4th

Quote:

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We would like to provide an update that the Biologics License Application (BLA) for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients will be considered completed after the clinical datasets are submitted on May 11, 2020. The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date.

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