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LongRun8

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LongRun8

Re: marthambles post# 2208

Friday, 10/15/2021 6:06:17 PM

Friday, October 15, 2021 6:06:17 PM

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I guess, but I don't think the dataset was really ever an issue. Daxi looks safe and effective. When PDUFA was delayed last year, FDA said there was no issue with BLA and that they were only waiting to do inspection.

Then after all the extra time they got with changing vial size and the FDA's delay, RVNC still seems like they were caught completely unprepared when inspectors showed up.
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