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Re: Biobillionair post# 33928

Tuesday, 09/09/2014 4:33:26 PM

Tuesday, September 09, 2014 4:33:26 PM

Post# of 447275
With the planned 15% eff. and 5,2% event rate (5,65% placebo, 4,78% Vascepa arm) we are at app. 568 event today (average follow-up 18 months).

If eff. is higher than 15% - I think yes - the event# is lower (25% = 537 event).

Regarding higher event rate, do not forget that the reason behind the SPA modification (increasing the min TG from 150 to 200) was the lower than expected event rate in May 2013. The change definitely increased the event rate, hopefully to the planned rate.

AMRN has access to data, but not to all and not by arm / patients (just to overall data) so they could not conclude anything regarding the result.

We could expect any announcement after the interim analysis (around Q2-Q3 2016 as the earliest) IF DMC (based on interim analysis and the stopping rule) will propose the stop AND IF AMRN will accept the recommendation.

I could not determine the exact time when AMRN will see any unblinded data, analysis, but definitely not before DMC recommendation (if any.)

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investor site presentation: ??? It is 1 month old

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