Amarin Corp Plc (AMRN): j- Why did they include the following st...

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HDGabor

Re: johngnatt post# 327775

Tuesday, 03/02/2021 8:29:20 PM

Tuesday, March 02, 2021 8:29:20 PM

Why did they include the following statement when Vascepa did not have this label before Reducte-It.
“the effects of its product “on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined”

By including the language of >500 , they are also implying and inducing that EPA can be used for CVD below 500 but not above 500.
Any mention of CVD was not part of Vascepa label before 2019.

FYI:

HIGHLIGHTS OF PRESCRIBING INFORMATION; VASCEPA® (icosapent ethyl) Capsules, for oral use; Revised: 07/2012

HIGHLIGHTS OF PRESCRIBING INFORMATION; VASCEPA® (icosapent ethyl) Capsules, for oral use; Revised: 2/2017

The effect of VASCEPA on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

Best,
G

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