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Re: marzan post# 198800

Thursday, 06/27/2019 4:09:16 PM

Thursday, June 27, 2019 4:09:16 PM

Post# of 425920
Marzan,

No word from the FDA to the sponsor on plans to hold an AC meeting either way by now is unusual, especially for Priority Review applications. And when unusual things occur with the FDA, especially where a significantly exceeded timeframe on receiving expected information is concerned, it is often negative.

Good luck to you.



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