Craigakess this is not true and has been discussed
Post# of 153822
(Total Views: 774)
Posted On: 09/01/2020 1:57:21 PM
Quote:Incorrect. CytoDyn's BLA application will not be APPROVED in weeks.
Craigakess this is not true and has been discussed at length on other boards via published RTF FDA protocol. We do not have to restart from go. The approval for the BLA will likely be weeks, not months if CytoDyn has allayed the FDA’s stated concerns in written deliberation.
- The FDA has 60 days after BLA application submission to issue a RTF.
- If the FDA does not issue a RTF, they have 74 days to ACCEPT a BLA application and issue a PDUFA date.
- The FDA is not obligated to ACCEPT a BLA application at 74 days.
- Once the PDUFA date has been issued, if the FDA has accepted CytoDyn's request for a Priority Review, the FDA has 6 months to render a decision regarding the possible APPROVAL of a BLA application.
https://www.globenewswire.com/news-release/20...roval.html
So, no, the BLA application will NOT be APPROVED in weeks.
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