Amarin Corp Plc (AMRN)

[Biobillionair]

Here's the key takeaway:

P value. At 60% the RRR wasn't > 25% with p<0.0076 but at 80% and certainly before 100% Amarin expect both RRR >25% and p<0.0220.

We have previously noted that the bar to stop the trial for overwhelming efficacy on the primary endpoint at this interim is high (p<0.0076 to hit significance) with certain secondary endpoints needing to be directionally favorable as well, therefore this outcome comes as expected. We make no changes to our PT and maintain our Buy rating. Second Interim Analysis Expected in Mid-2017: The onset of ~80% of the target aggregate primary events for the second prespecified interim analysis is expected in H1 2017, with the analysis by the DMC expected in mid-2017. The p-value to stop the trial for overwhelming efficacy at this interim is p<0.0220 for the primary endpoint, with certain secondary endpoints directionally favorable as well. The addition of the second interim therefore gives them a second shot-on-goal, potentially moving up the timeline for Vascepa expansion, if successful. At this time, we continue to model a favorable outcome on final analysis where p<0.0422 is needed for success, expected in early 2018.

JMO
BB