Amarin Corp Plc (AMRN)

[Biobillionair]

Unfortunately we can’t predict what the FDA asserts the agenda is... ANCHOR

Agenda: On October 16, 2013, the committee will discuss the supplemental new drug application 202057/S-005, VASCEPA (icosapent ethyl) capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. VASCEPA is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides, non-high density lipoprotein cholesterol, apolipoprotein B, low-density lipoprotein cholesterol, total cholesterol, and very low density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.

INSTEAD: Agenda was to get negative vote to rescind SPA

Science of the day already supported: This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides, non-high density lipoprotein cholesterol, apolipoprotein B, low-density lipoprotein cholesterol, total cholesterol, and very low density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.

See Jenkins science here:

https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-3266-0007&attachmentNumber=17&contentType=pdf

FDA will argue efficacy if Ad Com happens.

I can rest after my fatal MI...

BB