It seems clear to me that the review is designed t
Post# of 148110
(Total Views: 934)
Posted On: 09/15/2020 10:32:17 AM
It seems clear to me that the review is designed to only look for shortcomings in just the revised Combo HIV BLA submission.
CytoDyn would be crazy to not take this path, even at the cost of losing 30+ days to the process.
Notwithstanding evidence of inexperience and mistakes by CytoDyn and Amarex, and objectively unreasonable demands by the FDA -- the forces working to deny this indication are strong. They will have less leverage if the FDA 'blesses' the application prior to final submission.
CytoDyn would be crazy to not take this path, even at the cost of losing 30+ days to the process.
Notwithstanding evidence of inexperience and mistakes by CytoDyn and Amarex, and objectively unreasonable demands by the FDA -- the forces working to deny this indication are strong. They will have less leverage if the FDA 'blesses' the application prior to final submission.
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