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Posted On: 09/10/2020 9:25:12 PM
Post# of 148899
Re: thriftycents #55181
I am thinking that the CC delay is too allow time for the filing of the revised HIV BLA. I expect that the BLA will be filed the day of the CC.
It is likely that both the FDA and MHRA are waiting for the CD12 interim results before granting an EUA. The CD12 trial could have safety and/or efficacy issues as so many phase 3 trials have had. It would be very bad for the agencies to grant approval and then the CD12 phase 3 trial fails. My 2 cents.
It is likely that both the FDA and MHRA are waiting for the CD12 interim results before granting an EUA. The CD12 trial could have safety and/or efficacy issues as so many phase 3 trials have had. It would be very bad for the agencies to grant approval and then the CD12 phase 3 trial fails. My 2 cents.
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