Do you have a source for that definition? Here is the exact quote from the REDUCE-IT paper (hyperlink) regarding primary and secondary prevention cohorts,
This definition was also used in the most recent 10-Q (hyperlink),
This language is also used on the Vascepa website (hyperlink),
Is it possible you're confusing "primary prevention" with "first events" as shown on slide 12 (hyperlink) and described here (hyperlink),
In regards to ezetimibe, I was responding to this comment (hyperlink),
Ezetimibe does have a relative risk reduction (RRR) in cardiovascular outcomes that is less than Vascepa (6% in IMPROVE-IT vs 12% in REDUCE-IT), however, Ezetimibe is approved for dyslipidemia (hyperlink), not cardiovascular outcomes. Like Ezetemibe, Vascepa is approved for dyslipidemia (hyperlink), however, Amarin wants to expand the label to cover cardiovascular outcomes based on REDUCE-IT results. Therefore, I am indeed suggesting that the FDA is convening an AdCom because they do not think a 12% relative risk reduction in cardiovascular outcomes is sufficient for expanding the label to include the primary prevention cohort (i.e., patients had diabetes mellitus and at least one additional risk factor).