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Re: Just the facts maam post# 13130

Friday, 10/29/2021 5:15:44 PM

Friday, October 29, 2021 5:15:44 PM

Post# of 16485
One way or another, the FDA made a decision. I can't imagine a Complete Response Letter at this stage. At most, an extended PDUFA date, which will cause some heartburn, but will not be the end of the world.

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