(Total Views: 715)
Posted On: 07/30/2020 6:00:12 PM
Post# of 153908
Quote:Since the FDA demanded the Integrated Assessment of the CD03 Mono data (under the guise of wanting the Mono safety data), I believe Dr.NP is going to ask the FDA for updated guidance regarding the approval process for Mono.
On previous calls Nader had indicated we would definitely need to do a Phase III for HIV monotherapy and this BLA submission would not cover that. Has this changed?
My assumption is that CytoDyn is going to explore the possibility of a Mono approval without the Phase 3 Registration trial currently slated to begin by the end of the year.
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