JL I can't argue with anything in your post. Up until my experience with Amarin I always thought that procuring an SPA gave the developer a safer framework within which to proceed clinical trials towards drug approval. Someone may know the answer to my question as to how many times something like this - a recision of an SPA - has happened?
If we can trust or believe the FDA (not much confidence in what they actually say) they based their decision in part on results from a few outcome trials such as ACCORD, AIM, etc. But to me either they were simply using those as an excuse or they demonstrated a sad lack of science acumen.
Those trials were not designed to show clinical benefits in the type of population Anchor covers. Most of the subjects in those trials had normal to borderline high triglycerides and so in interpreting those results and trying to apply them to Vascepa the FDA should have known better.
The SPA covered an outcome trial (Reduce-It) that was substantially enrolled and FDA would have their results in a few years. No logical or scientific reason in my book for the action they took.
Just a little side note. Just as it was pointed out (I believe by you) how the FDA says nothing about 180 mg EPA over the counter being touted for CVD, let's just look at the NIH. They categorize triglyceride levels partially according to CVD risk, calling 150 to 200 borderline high risk and 200 to 500 as high risk.
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