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jessellivermore

05/12/14 10:11 AM

#27428 RE: HDGabor #27427

HD..

Great summary and I concur. Of course there are even more options depending on the need and urgency. The science is extensive and very compelling (in Amarin favor). This could offer a very strong First Amendment argument, not to mention the saving of lives..

Thanx...":>) JL
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sts66

05/12/14 4:25 PM

#27468 RE: HDGabor #27427

You just proved the point that people are still debating - did or did not AMRN ask for CVE risk reduction on ANCHOR label prior to completion of R-IT?

Based on BD, AdCom transcript:
Amarin indication: “Vascepa 4 grams per day is indicated as an adjunct to diet and in combination with a statin to reduce triglycerides, non-HDL, Apo B, LDL, total cholesterol, and VLDL in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk-equivalent, as defined on the slide.


That's exactly what got them in trouble - if you cut out the red words you have a "pure" ANCHOR label w/o assumption of positive R-IT trial results.