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Whosetosay

03/16/19 10:51 AM

#3050 RE: dtdude #3049

dtdude, you are 100% correct. 302RECOVERY study makes or breaks this company, pretty much. Cash to fund 302 is the key obstacle at this point. 302 has beneficial changes over 301.

Any thoughts as to why the retrospective data alone as in the corporate presentation could not justify an NDA? The p values are impressive on the select population. Why isn't the DoD pushing the FDA to move on this?

Unmet need. Strong efficacy in retro group. If POTUS is fully engaged and serious about recently mentioned initiative to address soaring PTSD veteran suicides, FDA/DoD must act. $8.6B annual PTSD budget. Any drug that can reduce PTSD suffering, even if in a partial population , i.e. <9 years, must be approved. Can reduce PTSD suffering by 20% in that pop. It is important to note, every day that passes without approval, more PTSD sufferers slip out of the <9 year window.