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Re: 67stang post# 25149

Friday, 02/07/2014 9:18:34 PM

Friday, February 07, 2014 9:18:34 PM

Post# of 425640
67stang - It was on their application and written by Amarin.

I talked to him directly and ask him why it was added or even on there and he said it is normal to include your true endpoint and/or goal on your label...

It is also their "creed": For Treating People at Risk for CVE's...

Why else do you think they exist? Just to better Lipid Panel Results?

We could ONLY have hoped that was the ONLY path they took with Anchor!

Do you think for a second that Amarin's Anchor submission was only going for the Treatment of people with Trigs in the 150 to 499 group?

Absolutely not...

Here is a press release right from Amarin - do you think the FDA made them put the BOLD CVE language in the article?


It's loud and clear: We are treating people at risk for CardioVascular Disease...

That is like saying consuming Dark Chocolate is good for you so we want the FDA's OK to sell Dark Chocolate because it will reduce High Blood Pressure (see below) when their is no current proof of it... (That is the goal of Reduce-It so the FDA told us to slow the "F" down...)

Dark Chocolate Lowers Blood Pressure

Dark chocolate -- not white chocolate -- lowers high blood pressure, say Dirk Taubert, MD, PhD, and colleagues at the University of Cologne, Germany. Their report appears in the Aug. 27 issue of The Journal of the American Medical Association.



That is/was a smack right in the face of the FDA so they said:

"Ain't happening!"


http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=569648


The purpose of the ANCHOR trial was to demonstrate that AMR101 is effective in reducing triglyceride levels in patients with high triglycerides without increasing LDL-C ("bad cholesterol") levels in patients on background statin therapy. The ANCHOR trial investigated AMR101 as a treatment for high triglycerides (=200 and <500mg/dL) in 702 patients with mixed dyslipidemia (two or more lipid disorders) on background statin therapy at LDL-C (low-density lipoprotein cholesterol) goal who were at high risk of cardiovascular disease.[/quote]


PLEASE KEEP IN MIND: I am a Long and In-Deep Investor who completely agrees with the Science!

I just feel Amarin should have left the CVE language out of the Anchor Submission 100% like they did in the Marine application!

John

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