I think your assessment is correct, however I'm still not sure if he was saying the protocol is due now for a future HIV indication study, or if he was saying the protocol was due after the partial hold was lifted. Unfortunately, his 09:24 comment really muddies it up. Specifically, what did he mean by "we" when he said "with respect to the information that we would like to see addressed."?
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So, in March 2023, just last month, we responded and submitted the additional information, and the clarifications requested for those 2 items. The 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.
09:24: So, at the end of March 2023, just last month, we had, an informal meeting with the FDA, where the agency clarified some of our more specific questions with respect to the information that we would like to see addressed. The risk / benefit portion, of the clinical hold and work on finalizing the supplemental submissions to address the items that we discussed with the agency during that informal meeting and we remain fully committed to the submission of the complete response to lift the partial clinical hold for that indication.
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My comments are just my opinions and should NOT be taken as investment advice.
