Failing to include statin-intolerant patients — when doing so was obvious, feasible, and potentially game-changing — meets the threshold of gross negligence, if not willful disregard of fiduciary duty.
Do you understand why the company ran Reduce It? They wanted the Anchor label. Lovaza 2.0, 10x the market when Lovaza going generic, trig reduction = implied CVD benefit no increase in ldl-c. FDA wouldnt accept Jelis data, so FDA told them they could have it if they had Reduce It ~50% enrolled, signed an SPA allowing it. If the FDA didn't make them run it, they never would have done it. Amarin just copied Jelis with western diet/population selecting the sickest cohort they could find to make sure it turned up good. Amarin never intended to market a pure CVD prevention label. They just ran with Reduce It and tried to make something out of it.
If there's negligence, it's not suing the FDA after Anchor SPA got taken away, or coming to an extended data exclusivity agreement for Marine as a concession for pulling a legally binding agreement while waiting on Reduce It readout.