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Re: 3X Charm post# 203943

Friday, 02/18/2022 4:43:39 AM

Friday, February 18, 2022 4:43:39 AM

Post# of 233759
They have the EDC system and TMF. Those are obviously in the MSA. You can refer to Cytodyn vs. Amarex for proof. The data in the EDC was not appropriately transferred to the FDA during the BLA submission. Amarex wouldn't allow Cytodyn to have the database, so they were solely responsible for all clinical data in the BLA. Do you even know what is included in a BLA?
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