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Re: yellow_bluff post# 8609

Monday, 06/17/2013 1:17:28 PM

Monday, June 17, 2013 1:17:28 PM

Post# of 426734
Adcom reviews safety and efficacy, would be a pretty easy Adcom, The reason they would hold one is guidelines recommend there be one in this instance.
They can always ignore the guidelines because it is so obvious in this case but FDA is rather conservative so since it is recommended they have an Adcom they probably will. The guidelines were put in place to have something to follow, it is rare a drug such as Vascepa comes along, no side effects, meets all endpoints so guidelines were not really written with Vasepa in mind, it just happens to be the first fish oil drug in High trig thus automatically it is recommended to have an Adcom.
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