from YMB:
Indeed, Reduce-IT was an outcome study. I'll repeat / paraphrase some comments regarding the critical importance of this point to investors, analysts, and most importantly the medical community.
Reduce-It was an outcome based study. "Does taking Vascepa together with statin result in lowering CV risk?" The outcome answer was an emphatic "Yes, by a 25-30% reduction". The method of action, while not fully understood, is multifactorial, not just lowering of triglycerides! This is critical to understand, and critical for AMRN to remind the world for two reasons: (1) as you point out, it allows for the broadest label possible irrespective of triglyceride level; and (2) because Reduce-It was outcome study not a lowering triglyceride study, no other drug or supplement can piggy-back off of Reduce-It to state that since their drug lowers triglycerides, then there is a CV risk reduction. AMRN / FDA, whether intentional or not, designed Reduce-IT as an outcome study specific to Vascepa, not applicable to any other drug that isn't pure EPA. Point 3: You hit this one on the head. JT is sending a message to the investment world, but more so to the FDA and potential suitors / competition, that the Reduce-IT was an outcome based study, so no piggy-backing on Reduce-It to suggest simply lowering triglycerides reduces CV risk. In short, Vascepa has a monopoly until patents run-out or another company can produce another Reduce-It like study for their own drug.
^^^from my understanding this is why Vascepa going to be such a HUGE deal. Its gonna be VERY beneficial to everyone with ANY kind of CV risk factors regardless of TG levels. Just look, were nearing a half bill in sales in 2019 while only being approved to treat TG levels that's over 500. Just picture what those sale numbers will look like if were approved for TG levels that's 135, or above. And that's just the tip of the iceberg, what many are thinking the ADCOM was needed is because the FDA needed more info because they see the Vascepa is beneficial no matter your TG level. So, what will those sells numbers look like if this is approved for anyone with any CV risk (elevated TG, Plaque build up, Obesity, Diabetic, etc, etc)? And this isn't yet factoring in the Evap study, the VA's Alzheimer's study (BRAVE is the name of the study if I remember right), and the different Cancer related benefits, etc, etc