Thanks for finding and posting the smoking gun. Ka
Post# of 148179
(Total Views: 588)
Posted On: 04/20/2024 11:45:30 PM
Thanks for finding and posting the smoking gun. Kazempour’s attorney should take one look at that and advise him to cop a plea.
Quote:
We have communicated to you multiple occasions as well as provided you with the link to Guidance entitled "Guidance for Industry Expedited Programs for Serious Conditions -- Drugs and Biologics", whereby we clarified that the BLA review clock does not begin until the applicant informs the Agency that a complete BLA was submitted.
Your April 27, 2020, submissions do not constitute a completed BLA as Cytodyn has reported to the public via press release.
The BLA application is not considered complete as you yourself acknowledged in your covering letter with the April 27, 2020, submission --noting that the clinical datasets remain outstanding.
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