My guesses re RI -
I currently believe the odds of RI being stopped for efficacy at the 80% interim analysis (IA) are roughly 50-50, but if pressed for a guess, I'll go with stopping early for efficacy. I believe IA timing is based on Amarin's projection, which looks ahead based on their quarterly event updates. I suspect their model reached 80% around January 25 (based on event 967 around mid-March 2016 and projected event 1612 around end of 2017). I don't expect them to announce attaining 80% until they receive their next batch of data around March 31, 2017. (Recall that they didn't announce their belief that event 967 had occurred until March 31, 2016, when they said it had already occurred a vaguely specified amount of time earlier, late in Q1.) On or around March 31, 2017 I expect them to say they believe event 1290 occurred sometime in Q1. My guess for when results of the IA are announced is around May 20, 2017. I expect it to take less time than the 60% IA because before they had to do all the check-ups, and they will benefit from the work done for the prior IA. Despite my reasons for the May announcement, I would not be shocked if it were a month or more later.
If stopped at 80%, I expect RRR around 38% (plus or minus about 15% or 20%, by which I mean RRR between about 18% and 58%). I believe the non-stop at the 60% IA was probably primarily due to secondary endpoints (subgroups). Note that if some V benefits aren't fully felt until after the first year or two (which seems likely), then we should expect measured RI performance to increase in its later years. This helps bolster the case for possible IA efficacy stop at 80% or, if RI continues, for strong efficacy at the end of the trial (as Amarin has guided).
Summing up: I guess stop at 80% IA with RRR about 38%, with event 1290 having occurred around January 25, 2017 but not announced until March 31, 2017, and with results of the 80% IA announced around May 20, 2017.
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