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Re: ggwpq post# 213635

Wednesday, 09/11/2019 9:44:50 AM

Wednesday, September 11, 2019 9:44:50 AM

Post# of 425688
Once again, there is no indication that the PDUFA date will be delayed. It is the FDA's fault that they failed to schedule AdCom in August. AdCom will be November 14th and then they will have final label negotiations. Final approval will come before the end of the year.
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