Thanks Goosebumps. I share your concerns about saf
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Thanks Goosebumps. I share your concerns about safety. We were told it was super safe, and I believe that is true. But then we got holds based on lacking aggregated safety data
SAEs would have been reported to the DSMB and Cytodyn by the Institutional Review Boards or oversight boards where the trial is taking place. Cytodyn would be responsible for reporting them directly to the FDA bypassing Amarex. If there were notable problems the DSMB boards and the FDA would have halted the trials well before now,