Replies to post #224147 on Amarin Corp Plc (AMRN)

[rafunrafun]

SG -

That's reasonable. The text in bold is indeed what I am predicting to be the question that's presented to the committee.

And here is why that arguement is weak:

But the justification behind that is weak. (On the primary 5 pt MACE the interaction term was p=0.14 and the protocol says below 0.15 would be considered significant, so yes, there is evidence in 5 pt MACE that there is a difference in efficacy between populations. The counter argument to that would be that the FDA focuses on Hard MACE. And the Hard MACE primary prevention data is compelling (with no SS interaction test).

Thanks, AVII!