It was revealed to us on April 11th.
Here is exactly what Cyrus said, below. It's open to interpretation, but my opinion is that he was saying they FDA still needed more info about benefit/risk. Now the FDA was also "requesting submission of a new Protocol for HIV indication," but since Cyrus said this was "to be studied once the Partial Hold is lifted," it's not clear that this needed to be done IN ORDER FOR the hold to be lifted. (Or, alternately, if CYDY is not going to develop Leron for that indication, we needed to tell the FDA that.) Let me know if this is how you read the following, HH:
Here is exactly what Cyrus said, below. It's open to interpretation, but my opinion is that he was saying they FDA still needed more info about benefit/risk. Now the FDA was also "requesting submission of a new Protocol for HIV indication," but since Cyrus said this was "to be studied once the Partial Hold is lifted," it's not clear that this needed to be done IN ORDER FOR the hold to be lifted. (Or, alternately, if CYDY is not going to develop Leron for that indication, we needed to tell the FDA that.) Let me know if this is how you read the following, HH:
Quote: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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