Amarin Corp Plc (AMRN)

[Biobillionair]

I’m not sure she’s a problem; she could actually be a Senate HELP plant, I can’t get confirmation on Amarin’s opinion. Anyways it’s getting very exciting behind the scenes...I’m not communicating with FDA anymore until after label change. My last Woodcock email:

Janet-
ICER understated the value of Vascepa and it certainly doesn’t highlight the overall costs savings in healthcare to the US as a whole, but ICER is correct the drug is underpriced.

Vascepa’s estimated net price ($1,600-2,000) falls below ICER‘s estimated price of $3,400 – $6,200 required to achieve their $50,000 to $100,000 QALY threshold — and nearly 100% of iterations met the $50,000 threshold, noted Jefferies’ Michael Yee. “(H)ence Vascepa is possibly “underpriced” relative to the key benefit thresholds used by ICER.”
https://endpts.com/icer-backs-cost-effectiveness-of-vascepa-xarelto-epizymes-lead-drug-wins-speedy-us-review/

Please expedite the “Priority Review”; as you are well aware, in my opinion label expansion is 6 years overdue. Additionally, it would be helpful for the FDA to finally include Vascepa into full “Program” status, there’s been significant monetary damages done directly due to the FDA not abiding by the Moss Federal Court decision.
https://investor.amarincorp.com/static-files/512592f8-f7c1-43ed-abf6-5523e6d1e3fe

The FDA should consider posting comments to ICER review regarding the understated value placed on deaths, and absent data on revascularization procedures and hospitalization for unstable angina.

Thank you for the consideration

Woodcock/FDA/Senate HELP & Amarin are fully aware I file my HHS complaint after R-I label, any further delays are unexceptional. Delays have caused increased CV deaths and wasted Billions in healthcare. Amarin raised enough cash to take any further delays out of FDA hands and that’s great strategy.

Brilliant timing on FDA FOIA requests, FDA can’t slow roll requests because they need to cover their asses and expose the industry influence just prior to ANCHOR SPA.

BB