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Posted On: 10/06/2021 2:44:48 AM
Post# of 148899
Quote:
I was under the impression that the BLA would be submitted before the end of the year. I wonder if that is still accurate.
Cytodyn was trying to get the raw data from Amarex so the new CRO could fix the BLA. That never happened and an attempt can't be made until they get the data. If Amarex was not tracking data properly then a proper BLA could never be filed. If that's the case then Amarex needs to be sued for massive damages.
But as I've said before I'd be just as happy if they abandoned the BLA and filed a protocol for phase 3 monotherapy.
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