Asking for protocol is probably why CA chuckled at
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Posted On: 05/04/2023 3:44:39 PM
Re: HHIGambler #134424
Asking for protocol is probably why CA chuckled at the last CC. I really wish he had said "we were just trying to get a hold lifted and they asked for protocol for an upcoming trial" which was a surprise. Does suggest that they are working on something like an HIV BLA.
From the CC: "FDA then responded back with a 3rd further written communication to us, again relating to the benefit / risk assessment as well as requesting submission of a new Protocol for HIV indication to be studied once the Partial Hold is lifted or some clarification that CytoDyn may not continue to develop Leronlimab in that indication.... we remain fully committed to the submission of the complete response to lift the partial clinical hold for that indication."
My question: Why wasn't the hold on Covid lifted right after the DSMB evaluation? I know CYDY is no longer going after Covid but that's our business, not the FDA.
From the CC: "FDA then responded back with a 3rd further written communication to us, again relating to the benefit / risk assessment as well as requesting submission of a new Protocol for HIV indication to be studied once the Partial Hold is lifted or some clarification that CytoDyn may not continue to develop Leronlimab in that indication.... we remain fully committed to the submission of the complete response to lift the partial clinical hold for that indication."
My question: Why wasn't the hold on Covid lifted right after the DSMB evaluation? I know CYDY is no longer going after Covid but that's our business, not the FDA.
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