According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that:
- Axsome’s chemistry, manufacturing, and control (“CMC”) practices were deficient with respect to AXS-07 and its manufacturing process;
- Axsome was unable to resolve these CMC problems or complete stability studies on additional batches of AXS-07 before it belatedly (after repeated delays in the initially represented timeline) submitted its AXS-07 NDA in June 2021;
- accordingly, the FDA was unlikely to approve the AXS-07 NDA;
- as a result of all the foregoing, Axsome had overstated AXS-07’s regulatory and commercial prospects; and
- as a result, the Company’s public statements were materially false and misleading at all relevant times.
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