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Re: BioInvestor4 post# 75989

Thursday, 05/07/2020 7:53:39 PM

Thursday, May 07, 2020 7:53:39 PM

Post# of 232976
NP has admitted to not finishing the BLA - read the PR from tonight. It says:

“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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