Axsome Therapeutics Inc (AXSM)

[georgejjl]

AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine. AXS-07 consists of MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) meloxicam and rizatriptan.

Interestingly both meloxicam and rizatriptan are FDA approved drugs currently on the market.

Therefore, the FDA may only have minor questions about the chemistry, manufacturing, and controls (“CMC”) issues identified during the FDA’s review of the Company’s New Drug Application (“NDA”) for its AXS-07.

Good luck and GOD bless,