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Re: jessellivermore post# 28229

Tuesday, 05/27/2014 12:36:59 PM

Tuesday, May 27, 2014 12:36:59 PM

Post# of 426567
JL,

The enrollment data is available in http://seekingalpha.com/article/1901351-amarin-todays-market-is-underestimating-the-probable-success-of-reduce-it (© Biwatch - slide 71 presented by Amarin during the Adcom of October 2013) and 10-Qs. I used a conservative approach ie.: I used 300 enrollment during Q1 as 31/03 enrollment (did not spread over the quarter).

Use the yearly 5,2% event rate and 15% efficiency 384 events occurred YTD together in Vascepa and placebo group (3400-3400 patients).

If you ‘know’ the event rate, the enrollment and the expected eff. it’s easy to calculate the expected time. The Power is more complicated but Biwatch did the calculation for requested min. eff. with 90% power for diff. % of events.

Unfortunately, its theoretical only, since under SPA the interim analysis will be done at 967 events and the expected time is not earlier than Jan-2016. If eff. is higher than 15% - and we all believe yes – it will happen later: July-16. And it’s the time for data collection, not for the publication of result!
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