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Did someone say SAFETY?

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All of those statements go to efficacy, not safety. But safety goes all the way back to the phase 1 trial done by Progenics and all the way through the NASH trial (not done by Amarex). Even with the Amarex studies all SAEs and AEs would be presented to a Data and Safety Monitoring Board (experts not associated with Amarex). They would be required to determine whether any SAE/AE is due to leronlimab and pass that information to Cytodyn who is required to report it to the FDA. If the FDA had any reason to believe that Cytodyn's statements that leronlimab had not caused any SAEs were false then they would have crucified Cytodyn then and there.

That two SAEs in Brazil, one determined to be in the placebo arm and I believe the other was determined to be caused by the underlying illness (Covid) were used to put a clinical hold on leronlimab is rather infuriating.