Axsome Therapeutics (NASDAQ:AXSM) has completed a successful pre-New Drug Application (NDA) meeting with the FDA for AXS-07 for the acute treatment of migraine.
The purpose of the meeting was to reach an agreement with the Agency on the proposed content and format of the Company’s NDA submission including the clinical and nonclinical requirements.
The company remains on track to submit the planned NDA in Q4.
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