Amarin Corp Plc (AMRN)

[HDGabor]

sts-

We're home free: Amarin could (and will) stop the trial if DMC recommends the stop. FDA does not have ANY rule / right at this stage.

Furthermore, if the R-IT will meet all requirement (it will) FDA could rescind the SPA and it won't change anything: it is a hard outcome trial!

btw: you did not understand / follow the context: it was about contact w FDA or not. I suggest to read the entire conversation on IHub, not just 1/2/3/.. word/sentence.

The cited CC was:
"Akiva Felt - Oppenheimer
I am wondering if you can may be give a little bit more color on exactly what the interim hurdle is for REDUCE-IT and what are the hurdles that the DMC is looking at in your view would be similar to the FDA's hurdle for a label expansion to include a cardiovascular outcome? Thanks.

John Thero - President and CEO
Steve do you want to jump in on that one?

Steve Ketchum - SVP and President of R&D
To maintain the integrity of the study we have purposely described few details regarding that 60% interim look by the independent DMC. It will be looking as you mentioned at efficacy and there is an overwhelming efficacy boundary that is pre-specified but we haven't publicly disclosed exactly how we arrived at that efficacy boundary in terms of looking at prior cardiovascular diabetes outcomes trials and those types of considerations that in conjunction with the steering committee and the DMC were settled upon and the protocol that was the subject of the FDA agreement. So there was obviously also discussion with FDA to arrive at those provisions.

Akiva Felt - Oppenheimer
Okay."