Amarin Corp Plc (AMRN)

[Biobillionair]

Just sent to Amarin, Senate, and FDA:

John-
My complaint to the OIG HHS (ANCHOR rescindment was “bad” for patients) is happening regardless of the timing of R-I label expansion. My immediate concerns are Amarin and FDA must agree on labeling. I propose Amarin requests the FDA to “rescind” ANCHOR SPA rescindment letter siting immediate public safety concerns of Omega 3 off-label prescription use; site weekly #’s. This puts FDA and Amarin on the same side while negotiating R-I labeling. I believe Dr. Woodcock will see an opportunity to advance an FDA agenda and get Amarin on track. It does not serve Amarin investors for Amarin legal to further push an off-label agenda; the R-I results are far to significant to risk further Amarin FDA discourse.

Again, I’m willing to serve as a catalyst to facilitate these communications. I believe this can be done through CDER Ombudsperson. I am planning a separate complaint to OIG HHS regarding CDER Ombudsman Office, this complaint is also imminent regardless of R-I approval timeframe. In my opinion the CDER Ombudsman has underperformed in her duty to facilitate proper FDA/Amarin communications, this has led to a number of unnecessary Federal lawsuits; all of which have been won by Amarin in Federal courts.

I also propose a conference hosted by the FDA early next week. This should be facilitated by CDER Ombudsperson. This discussion should discuss an accelerated approval and labeling expansion that quickly equals the current ADA standard of care.

I will also demand a full Senate HELP investigation and hearing to commence after the HHS OIG investigation report. Thousands of Americans have perished as the direct results of wide poor to corrupt interruptions of 21 CFR as evidenced by the massive FDA court losses to Amarin.

Please contact me if the FDA fails to reach out to you by the end of next week. I will include this communication and your response in my complaints.

Sincerely,

Jason Williams

I never break a promise, and I don’t intend to forget me promising Virginia Behr her Senate grilling.

BB