Amarin Corp Plc (AMRN)

[IslandOfMisfitToys]

Here's what they said in their May 2016 investor presentation:

Projected to provide 90% power to detect 15% relative risk reduction
? >95% power to detect >20% relative risk reduction

That obviously didn't come from nowhere. It would be a weird statistic to include just for the heck of it. My recollection is that they included a discussion in one of the patent applications that goes through the original trial design, and the changes that were outlined in the quote you provided.

The original design was 90% powered for a 20% reduction. I don't remember how many events were required, but it was considerably less than 1612 -- my estimate is that it was less than 1000.

Then the FDA wanted them to assume a lower RRR (15%) and a slower rate of placebo events (5.2% instead of 5.9%). That was what motivated the adding of patients (the extra 1000) -- to get the right number of events within the planned timeframe (median exposure of 4 years).

The geniuses on this board should be familiar with this, I would think.

It's not super important, but does indicate that AMRN mgmt originally saw 20% as very doable.