The worst case scenario in the 10q happened word for word. By approving snda earlier this year fda didnt identify additional risks or studies required....they convened adcom to offer additonal view point. I still feel its a large grey area and still dont see why they couldnt approve based on safety profile pending reduce it study. Judging from fda adcom, they didnt seem to think risk to benefit analysis was worth it. Again i am not a specialist in this area but i am hoping amrn comes up with a battle plan to conserve cash and pick up sales based on marine and off label.
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