Amarin Corp Plc (AMRN)

[Whalatane]

Gabor This isn't only about efficacy

Its also about the robustness of the data .

Dr Ketchum Feb 2016

Also as is typical for outcome studies and based on the design of REDUCE-IT, given the high thresholds of overwhelming efficacy and safety, and the robustness and consistency typically required to be achieved across key secondary endpoints and patient subgroups prior to an independent DMC recommending an early stop to a cardiovascular outcomes trial, we continue to believe that it is most likely that the REDUCE-IT study will run to its completion.

We want the results of the study to be clearly overwhelming, before it is stalled. This is the first outcome study ever conducted in this population and we don’t want to achieve the primary endpoint, stop the study early and later learn that some key secondary endpoint was trending positively, but didn’t reach the high statistical standard for success that is associated within interim look, but that might have proven success or have the trial continue to the next year or so to completion.

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Of course since you and JL know what the key secondary end points and sub groups are ...you have no problem determining the robustness and consistency of the data required .

Well OK then ...:>)
Kiwi