Amarin Corp Plc (AMRN)

[Biobillionair]

Regarding ITC Amarin complaint: (It's a long post but a must read)
Second attorney that signed Amarin's response to FDA was ex-attorney Lisa M. Dwyer. She worked very high level at FDA in Office of the Commissioner starting March 2010 to July 2015. I'm about 110% sure Amarin's attorneys at King & Spalding will prevail against any FDA ill intent. King & Spalding was recommended to me by another law firm you might have heard of Hyman, Phelps, & McNamara. HPM represent Amarin at the June 2012 Orange Book meeting; Kurt Karst is the god of exclusivity knowledge. IMO he knows the exclusivity schemes better than ALL the FDA attorneys combined.

Back to Lisa......

She is a partner in King & Spalding’s Washington, D.C. office and a member of the FDA & Life Sciences practice group. Lisa has more than 15 years experience working with legal and policy matters involving all FDA-regulated products. From 2010-2015, she served in the Commissioner’s Office at FDA as a Senior Policy Advisor, in the Office of Policy, and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, Lisa provided strategic counseling to FDA’s Commissioner and other senior leadership on the agency’s most significant and complex issues, including: off-label marketing, oversight of laboratory developed tests (LDTs), oversight of next generation sequencing LDTs/in vitro diagnostics (part of President Obama’s Precision Medicine Initiative), advancing antimicrobial drug development and use, modernizing the legislative framework for cosmetics (including user fees), public-private partnerships, menu labeling, implementation of the Family Smoking Prevention and Tobacco Control Act of 2009, opioid misuse and abuse, and the Commissioner’s Transparency Initiative. In addition, she often served as a liaison for the FDA or worked closely with other parts of the federal government, including the Department of Health and Human Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Drug Enforcement Administration, and Congress.

Before joining the FDA, Lisa practiced food and drug law at two prominent Washington D.C. law firms, where she advised clients on the impact of new legislative and regulatory developments; submitted extensive comments on proposed rules to FDA, the Federal Trade Commission, and the Social Security Administration; advised clients regarding corrective actions and recall strategies for FDA-regulated products; engaged in crisis management; and handled litigation matters in federal and state courts.----from her LinkedIn

Lisa knows exactly what happened to Amarin and Vascepa from the inside of the FDA. DS have NO chance but to roll over and give Amarin the market earned by conducting the R-I trial.

IMO, there's no question the ITC will take Amarins complaint and fully investigate; additionally, I suspect the FDA will have no choice but to fully cooperate, Lisa knows.....

Lisa also happens to have Senate HELP contacts...some of the same people I've directly communicated with... Wade Ackerman. Wade now works at Covington & Burling LLP....you know the NCE attorneys. Wade worked at FDA then Senate HELP, he was involve in the Amarin crap show since day 1. Many of the good attorneys have left the FDA....most are now on "our" side. The FDA doesn't stand a snowballs chance in hell in any fight against Amarin and they know this.

I predict ITC investigates and the FDA cooperates, it starts next Friday. The stock price will continue to suck, until Amarin gets justice...Amarin will get justice.

BB