Amarin Corp Plc (AMRN)

[johnking29]

Drr - I cannot post privately...

Not stated yet implied and picked up on by the FDA:

The sNDA presently is for use with statins in patients at risk of CVD (the following is from AMRN's brief to the panel)

Quote:
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Amarin Pharmaceuticals Ireland Limited (Amarin) submitted a supplemental NDA to the FDA on 21 February 2013 seeking approval of Vascepa for treatment of elevated (200 to 499 mg/dL) TG in patients with mixed dyslipidemia. The proposed indication is as follows:
Vascepa (icosapent ethyl) is indicated as an adjunct to diet and exercise and in combination with a statin to reduce triglyceride TG, non-HDL-C, ApoB, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.
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