Yes, I believe that is the case here. Rolling sub
Post# of 154726
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Posted On: 03/04/2019 9:32:27 AM
Yes, I believe that is the case here. Rolling submission to rolling review, see the pr last summer below.
Also, they mentioned Part 1 was ready to go in December. My guess is these discussions have been going on since December about he BLA, and the FDA already looked quickly at some items and responded with the 700mg change for safety data. I feel that the last of the fda surprises is behind us now with combo.
For last year the PR,
https://www.cytodyn.com/media/press-releases/...th-fda-for
Also, they mentioned Part 1 was ready to go in December. My guess is these discussions have been going on since December about he BLA, and the FDA already looked quickly at some items and responded with the 700mg change for safety data. I feel that the last of the fda surprises is behind us now with combo.
For last year the PR,
https://www.cytodyn.com/media/press-releases/...th-fda-for
Quote:
Our BLA filings may start as early as the end of 2018 and the FDA review process will start when the full BLA submission is completed and the FDA has accepted the BLA for review.”
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