Amarin Corp Plc (AMRN)

[VuBru]

Raf - FWIW - My guess is that they will request the TG level reflected in the original R-It protocol (TG = 150+). I think they will do this to play it safe, minimize possible negative discussion at an ad com (which might raise other issues they don't want to raise), and speed the process along. The NEJM paper indicates that they had a 150 TG cutoff initially, but per protocol allowed down to 135 to address daily fluctuations. This procedure was later dropped and the entry criterion was raised to a firm TG = 200. Only 10% of the sample had TG levels <150, and I am not sure whether statistically (at an ad com discussion) that would be viewed as enough patients to reliably determine whether V reduces MACE in this group the same as it does in high TG patients. I think there would be less pushback on the TG = 150, since that was explicitly the original entry criterion. Happy to be proven wrong, but that is my best guess.