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Re: Chris2125 post# 112364

Wednesday, 08/16/2017 11:06:29 AM

Wednesday, August 16, 2017 11:06:29 AM

Post# of 428969
Chris -- that was the final design.

It was originally designed to be 90% powered to detect a 20% RRR.

Then in discussions with the FDA (in the context of negotiating the original SPA that the FDA reneged on), the FDA wanted them to assume a more conservative RRR (15%), and keep the trial powered to 90% on that basis. So they had to add events -- 1612 were required to have that powering at that RRR assumption.

AMRN even notes in its investor presentations that the trial is over 95% powered now to detect a 20% RRR. The powering of the trial, assuming a 20% RRR, is actually over 99% (almost 99.5%).

I'm going to keep being as dorky as I can possibly be, and nobody, not even JL, can stop me!

BWAAAAAAAAAAAAAAAAAA....HA-HA-HA-HAAAAAAAAAAAAAAAAAAAAA!!!

“The trick is in what one emphasizes. We either make ourselves miserable, or we make ourselves happy. The amount of work is the same.” Carlos Castaneda

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