Amarin Corp Plc (AMRN)

[VuBru]

Kiwi -
Regarding your question, the problem is that there is no guarantee that the RRR and p value will get better at the end of the study - weird outlier data points do occur. There are cases where an effect observed at an interim analysis disappears when run to completion. I don't think this would happen, but it is a risk for the company, and it is possible that the RRR would not change at all between 80% IA and end of the study (but obviously the p value would increase). Given the example numbers you proposed, and assuming SEs were generally consistent so results would not be questioned, I would undoubtedly go for 18% RRR with p<.01 now rather than a slightly larger RRR and better p value later solely for purposes of getting an expanded label a year sooner. This RRR would beat FOURIER and it is significant. I know the p value is often misused, but in truth it is an a priori dichotomous decision. Significant is significant as long as it meets the criterion, no matter how small the p value is. BTW - An RRR of 18% would be more like p<.0001. All of what I have said is obviously just my opinion, but I am trying to think through a good rationale for my argument that the study might reasonably be stopped at the 80% IA.