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Posted On: 05/02/2019 9:59:45 PM
Post# of 151071
The 6 months referenced is for the FDA review itself. Timeline for standard review is 10 months. If a priority review is requested at BLA submission and approved by the FDA (approval would be announced by end of May) then timeline is 6 months. But I haven't seen anywhere where Cytodyn had requested a priority review.
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