Amarin Corp Plc (AMRN)

[Williams4076]

This is my plan, ALL are welcome to join...

1) I'm plan to forgo the litigation on my suit, FDA has not cooperated in time to supply me with the evidence to win.

2) I will file a new complaint, first my original complaint wasn't ripe and the new allegation was not completed.

3) This will be communicated to CDER Ombuds and HHS General Attorney office.

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Formal request to FDA through CDER Ombudsman will be made to reinstate Anchor SPA based on purely a request made from stakeholders. The timeframe will be before June 18th.

All administrative avenues have been exhausted by stakeholders when EPADI CP was denied.

With the CRL to sNDA005 the FDA has confirmed their intention to practice Medicine not Regulation.

It is Janet Woodcock duty to supervise all decisions and she was explicitly supervising during her part in the last formal SPA rescindment meeting. She was Negligent to not view the rescindment of Anchor and changing view on Trigs as the practice of Medicine. Case law has already ruled and considering her longstanding track record there's little to excuse this default in supervision.

Meeting notes are evidence.

Case law supports FDA not having the jurisdiction to practice Medicine.

Damages to stakeholders date back to the approval of Marine without Anchor label, this would have be equal and fair treatment considering Lovaza was able to have this equivalent study on label despite FDA rejecting approval due to increase in LDL.

If SPA not reinstated, we all file same action against FDA using SF95 form, all wording on forms should be the same. I am attempting to get the legal help of WLF to construct the complaint.

Who's in this?

BB