Amarin Corp Plc (AMRN)

[Biobillionair]

It's still there and lawfully should be updated with the actual agenda, "force the committee to vote on a question they must vote no to because it's worded in a way that forces them to predict the future" This is not water under the bridge...this is injustice.

Here:
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 proposesconcomitant 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.

https://www.regulations.gov/#!documentDetail;D=FDA-2013-N-0001-0078

Why is she working on a holiday? I'm not paying her OT;)

It violates 21 CFR 14.2 (a) & numerous (b)

This is fraud...DMEP charged and kept $970,000 PDUFA fee...but failed to follow CFR to earn the fee.

I never wanted to spell the crime out for them hoping they would self correct the error instead numerous other levels decided to be co-conspirators. Oh well. Sucks to be them.

Senate HELP AIDS have been CC'd in every communication, accountability isn't optional in my request...this is clearly stated in my "expected outcome".

BB