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georgejjl

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georgejjl

Re: None

Thursday, 08/18/2022 9:12:37 AM

Thursday, August 18, 2022 9:12:37 AM

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This coming Monday 22 August 2022 will be one year since the FDA had planned on making a decision regarding AXS-05 for treating MDD

"...The FDA had set Sunday, Aug. 22, as its PDUFA date to approve or reject AXS-05..."


From this months resent quarterly update:

"...With regards to our NDA for AXS-05 in major depressive disorder, or MDD, we announced that we have entered into labeling discussions with the FDA in late June. We have been pleased with the progress of these discussions. And based on the interactions, we anticipate potential FDA action on the NDA in the third quarter and potentially as early as this month...."

Good luck and GOD bless,
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