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Tuesday, 11/28/2017 10:13:47 AM

Tuesday, November 28, 2017 10:13:47 AM

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I'm really amazed AXSM hasn't garnered more attention. Looks like the Yahoo! message board has some activity.
Their pipeline is in great shape with results coming shortly.
I'm a little confused as to why AXS-07 isn't mentioned on their website. Going directly to phase 3 for this indication is excellent. With so few effective migraine treatments on the market, I think this will move quickly provided results are positive.


Axsome has received, from the U.S. Food and Drug Administration (FDA), Pre-Investigational New Drug Application (Pre-IND) written guidance on a proposed clinical developmental plan for AXS-07 including a planned Phase 3 trial. Based on this feedback, Axsome believes that only one Phase 3 trial may be needed for the approval of AXS-07 for the treatment of migraine. Axsome anticipates starting this trial in 2018 contingent on the availability of resources.


...

“AXS-07 is the second product candidate stemming from our MoSEIC platform which has the potential to generate additional proprietary new medicines,” added Dr. Tabuteau. “We are excited about the prospects of AXS-07 to address unmet medical needs in this important neurological condition and look forward to advancing it in late stage clinical trials as early as this coming year.”

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