(Total Views: 667)
Posted On: 11/10/2021 7:12:13 PM
Post# of 154031
Re: Evil Rabbit #110300
More bits of information from another board:
Aaron
"It was last week I believe that the FDA granted us a rolling review for the resubmission of the HIV BLA
Also, from Sidley's court documents, the FDA gave a letter to Cytodyn showing Amarex failed to file annual IND annual reports.
While it is definite that these issues with Amarex put the BLA in danger, it is apparent that the FDA is aware of the situation and is working with Cytodyn to get this completed.
From the very detailed answers in the RTF, I do not believe the FDA would keep moving forward if there was no apparent pathway."
Aaron
"It was last week I believe that the FDA granted us a rolling review for the resubmission of the HIV BLA
Also, from Sidley's court documents, the FDA gave a letter to Cytodyn showing Amarex failed to file annual IND annual reports.
While it is definite that these issues with Amarex put the BLA in danger, it is apparent that the FDA is aware of the situation and is working with Cytodyn to get this completed.
From the very detailed answers in the RTF, I do not believe the FDA would keep moving forward if there was no apparent pathway."
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