The FDA informed the company...that the HIV BLA di
Post# of 148026
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Posted On: 10/12/2021 6:35:45 PM
The FDA informed the company...that the HIV BLA did NOT contain certain information needed to complete a substantive review and therefore advised that the "third party" submission was not properly performed and required REsubmission...Cytodyn has disengaged Amarex... and has a global CRO and expects HIV BLA completion in the 1st quarter of 2022.
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