Amarin Corp Plc (AMRN)

[Biobillionair]

Analysis of the FDA's next steps:

JJ is not taking the decision to the next level, instead he's counciling with CDER policy makers. The Policy Board is an official entity with specific Guidances: HERE http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm344444.pdf

They have a specific purpose, HERE:

PURPOSE
This document describes the organization, membership, responsibilities, and procedures of the Medical Policy Council in the Center for Drug Evaluation and Research (CDER).
The CDER Medical Policy Council will provide senior support to the Center on medical policy development, including:
• Leadership oversight and medical policy management for the Center.
• Attention to, and management of, essential Center cross-cutting medical policy. • Advocacy for the activities of this Council and its Working Groups.
• Promotion and coordination of communication both internally and externally on the medical policy decisions made by the Council.

Congress & Courts will not let the FDA make up new policy to retroactively apply to NCE, or Anchor SPA...both the SPA policy and NCE policy are being rewritten...SPA Policy expired earlier this year.

IMO, old SPA policy was clear, new science could be used to cancel a SPA if it was a safety concern...this was pretense of Canceling Anchor...No official reason was given except Trigs was a poor surrogate marker of CVD, and treatment of 200-500 was strictly a CVD treatment. Policy was NOT followed in the rescission of Anchor (or NCE).

The FDA has realised they've made a grave error...quite literally. The former Medical Policy maker charged with making this "Original Decision" is gone...Fired?...unknown. She's been mentioned numerous times by me and now is likely making $7 figures at company started by another former FDA employee. Her former Government employees are now tasked with covering her butt (or exposing it if the need to save their asses).

Conclusion:
1) JJ does not support the lower decisions
2) These decisions where made "officially" below JJ at the Mark Parks, Eric Coleman, and Rachel Sherman level. This is where the FDA will lay the blame.
3) JJ's taking this to the upper CDER policy level, CDER Medical Policy level management changed Winter 2014
4) Full damage control with likely hood of Anchor increasing & likely turnaround of NCE (the FDA can't afford to lose a NCE challenge in court). The shear length of the no decision yet plays into the strength of Amarin's legal arguements. NCE will vacate numerous Amarin generic lawsuits...it does matter.
5) Upper FDA management want to be shielded from this decision, that won't happen with a "no"

!!!6) The decision will be reversed !!! just before elections (and in time to prevent me from litigating this in Federal Court)

7) Every time the FDA chooses not to reinstate Anchor & Delay they give more ammo to fire at their stone wall

BB