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Posted On: 04/12/2023 2:34:28 AM
Post# of 154476
Quote:
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 ....
1. What has a new HIV protocol to do with safety data analysis/ clinical hold of past clinical trials? What is their motivation to request this? (please do not give me the BLA resubmission bs)
2. The second part of the sentence almost reads like a thread from FDA. COVID indication was withdrawn by Cytodyn voluntarily, it seems FDA wants the same for HIV. If Cytodyn forward a new HIV trial, they will have questions, remarks, changerequest, meetings for the next six months.
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