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Re: exwannabe post# 17551

Thursday, 10/17/2013 11:48:04 AM

Thursday, October 17, 2013 11:48:04 AM

Post# of 427816
But who says they can not drop it down to 70% or whatever?

I am never using the expression "good news" again, even "a little bit of good news", so here is some news -- from the briefing docs:

REDUCE-IT is a multi-center, multi-national, prospective, randomized, double-blind, placebo-controlled, parallel-group study. Patients at high risk for CVD, or with established CVD, with elevated TG (200 to 499 mg/dL) despite optimized statin therapy, are randomized to Vascepa 4 g/day or placebo. The primary endpoint is a composite of CV death, nonfatal myocardial infarction (MI), nonfatal stroke, coronary revascularization, and unstable angina determined to be caused by myocardial ischemia by invasive/non-invasive testing and requiring emergent hospitalization. The study will require 1612 events to have 90% power to show a 15% reduction in the HR. Approximately 7990 patients will be followed for about 4 years median follow-up. REDUCE-IT is overseen by a Steering Committee and a Data Monitoring Committee.



It would not be scandalous for AMRN to suggest they drop the powering to 80%, I would think. This would drop the number of required events meaningfully (maybe so that current enrollment was adequate). An online calculator I found roughly tells me you'd need maybe 75% of the events, so since we have over 75% of the enrollees now, that might do it.

Keep in mind the 60% interim is still out there. One would not be off-base to now consider AMRN stock to be a call option on success at the interim.

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