Amarin Corp Plc (AMRN)

[sharinky]

BB This is how it actually reads. It is not an either/or, there are three separate populations discussed here.

Discuss whether the efficacy and safety data from the REDUCE-IT trial provide substantial evidence to support approval of an indication for Vascepa to reduce the risk of cardiovascular events.

If yes, discuss the population – beyond patients with established CVD – that should be included in the indication. Options could include, but are not limited to:

• adult patients with triglyceride levels greater than 135 mg/dL and additional risk factors for CVD, without regard for age, diabetes status, or adequacy of LDL-C control (proposed by applicant).

• Risk Cohort 2, which represented 30% of the REDUCE-IT trial population and comprised patients aged 50 years and older without established CVD, who had diabetes, one or more additional risk factors for CVD, and hypertriglyceridemia despite optimized statin therapy to achieve LDL-C less than 100 mg/dL.
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