Amarin Corp Plc (AMRN)

[AVII77]

I believe it was stated no "formal futility analysis".
What is your take on "formal" in this context? I took it to mean the is no defined number where the DMC will call it for futility, but if it were zero at 60/80%, then they would stop for no benefit. Your thoughts?

My thoughts are:
If the RRR% is at or near zero at the 80% interim there would be two benefits to continuing the trial:

1. Obtaining a definitive answer to the question: do high dose OM3's work? Truncating the trial might be cost saving but we might lose info - even if that info is 'let's put this OM3 stuff to rest'. If it fails, society will benefit from a more definitive answer obtained from a fully powered trial.

2. Management continues their paychecks for another year

Now, if they reach a definitive conclusion at the interim that there is absolutely no benefit or hint of benefit in any subgroups, the dsmb may be ethically obliged to stop the trial.

If there were a "formal futility" analysis, they might stop the trial for futility at the 80% interim if the didnt see at least a 9% RRR (just guessing at what a ballpark futility number might be). So, in that case, investors would know that after the trial being subjected to a futility analysis it was continuing, that would be good news.

W/o a futility analysis a continue is neutral.

Those are my thoughts anyway.