Amarin Corp Plc (AMRN)

[KCSVEN]

That's not the question, obviously it does not inhibit statins completely or even a lot as the lipid profile of the placebo group did not go to levels that they would if everyone stopped taking statins.

The question is did MO effect absorption to a level that would cause CVD risk to increase to levels that were found in RI trial. The Only study they could do is a 6 year study with a placebo and mineral oil and then see if the mineral oil group had more CVD. Of course, you CAN'T do that study because you are basically giving one group something that will not help them in anyway and might harm them.
So your left with a new study with Vascepa and no mineral oil, probably corn oil. But why? The evidence is not strong that MO effected the results so now you want 6 more years? While most scientists and doctors believe RI was a definitive practice altering study?

It does not matter the lipid change, the amount of serum statin concentration or anything else, just because those are effected has no bearing on whether they are effected enough to cause CVD. If they are not changed well maybe MO works in a way that this test doesn't show so you've proved nothing.

Jelis worked without MO. In RI The changes were not major over the whole study and subgroups show changes in LDL or other factors had no bearing, the FDA could approve label and request down the line study but I'm unclear what that study would be.

If there was a simple, short test/study someone would have done it.