Koo wrote: "Bear no matter what, the MACE lowering is what gave Amarin the big boost in their Market Cap. I can't see Amarin's 25% statistical significance in MACE would change from here on end. Why would it? Lowering triglyceride, with the only benefit, leaves Amarin a $3 stock. I guess the takeaway here is that lower MACE is more critical than lowering triglyceride. Hard to believe. If so that bodes well potentially, for Apabeatlone should it succeed."

Yes, the REDUCE-IT results gave Amarin a big boost in market cap. I am not arguing that point. And the database is locked, so the calculated %RRR will not change. No argument there. My point is that there is a difference between clinical trial result and FDA/EMA approval for marketing and labeling. Right now, the approved label for Vascepa is quite narrow. From the Vascepa website:

"FDA-APPROVED INDICATION AND LIMITATIONS OF USE FOR VASCEPA

VASCEPA® (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia

In patients with severe hypertriglyceridemia, the effect of VASCEPA on cardiovascular mortality or morbidity or on the risk of pancreatitis has not been determined"

Success in a clinical trial is not a guarantee for FDA/EMA approval. Rinse and repeat. Success in a clinical trial is not a guarantee for FDA/EMA approval. Like I stated before, there is a very high likelihood that Vascepa will be approved for the expanded label to cover patients with triglycerides 150 mg/dL and above and for cardiovascular indications. However, it is not a guaranteed slam dunk. A recent example is canakinumab in the CANTOS trial. Here's a couple articles on that:

Withdrawal of the marketing authorisation application for canakinumab Novartis (canakinumab)

FDA slaps down Novartis’ blockbuster pitch for canakinumab — so what went wrong?

BearDownAZ