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Sunday, 05/19/2019 1:12:31 PM

Sunday, May 19, 2019 1:12:31 PM

Post# of 430138
Most here seem to think priority review is a slam dunk based on Reduce-It and the science behind Vascepa. I had a near panic attack in the middle of the night last night. Has anyone considered the competence of the submission? The application, itself, could be rejected because it is improperly filed or is not structured properly or is missing key components. Additionally, for months I read that the submission was going to be 200,000 pages (+/-) then all of a sudden JT says it was over a million pages... there is not an agency on the planet that could process a million pages of scientific data in a year, much less the 6 months we are all hoping for.

I think there are a lot of heads in the clouds on this one. I hope for priority review, but I cannot imagine how that could even be possible given the complexity of the study and its submission to the FDA; Amarin's history with FDA, not to forget the very recent appeal with the FTC and the adcom debacle of the pre-Reduce-It days, and the politics behind a small, one-drug pharmaceutical company that will potentially knock out (as well as supplement) at least a few very big-named drugs. Not all BP's are on our side, and let's not forget assholes like Nissen, whose sole purpose in life is to kill Vascepa.



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