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georgejjl

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georgejjl

Re: None

Monday, 05/16/2022 9:35:59 PM

Monday, May 16, 2022 9:35:59 PM

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In April 2022, we announced that it has received and agreed to Postmarketing Requirements/Commitments proposed by the FDA with respect to the NDA for our AXS-05 product candidate for the treatment of major depressive disorder.

Based on this interaction, we anticipate potential FDA action on the NDA in the second quarter of 2022.



https://www.sec.gov/ix?doc=/Archives/edgar/data/1579428/000095017022006901/axsm-20220331.htm

Good luck and GOD bless,
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