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Re: Bolio98 post# 115458

Wednesday, 10/04/2017 10:39:27 AM

Wednesday, October 04, 2017 10:39:27 AM

Post# of 426453
Bolio,

I for one do not believe the FDA made a mistake on the SPA or Anchor. You have to go back in time and look at the landscape then, not now or 2013. They gave the SPA to foster competition. You had Fibrates and Niacin already approved, and were in the process of completing outcomes studies. Now, did they think ahead that maybe those 2 studies would fail. Maybe...either way, they decided that they would require an outcomes studies since those other trials failed in between the SPA being issued and the Anchor results. Again, someone could have come up with this plan of action before the SPA. The reality was it was handled poorly, but their intent was to always foster competition. They did not succeed and damaged AMRN in the process. For me at least, it's the best thing that could have happened. Hopefully someday you will feel the same.
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