Amarin Corp Plc (AMRN)

[Biobillionair]

New investment theory: Amarin is pushing FDA for Accelerated Approval designation for R-I based on RWE.

"Evidence":
1) ITC final action is at a standstill with the ITC using FDA playbook; stalling to determine final action.

2) Woodcock pipes up on RWE 2 days after Amarin releases Kaiser data on increase healthcare costs related to the FDA changing high trig treatment guidelines.
Woodcock comments here: https://www.fda.gov/Drugs/ScienceResearch/ucm583448.htm

Amarin/Kaiser RWE here: http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=1048753

This is the guidance for the industry regarding accelerated approval here:
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

The FDA "updated" the expiration of accelerated guidance 9-21-2017; Amarin may have requested review of guidance prior to "follow" it.

Timeframe of FDA decision? FDA announcement could take place at 100% last event; 60% and 80% interim could be unblinded to FDA after 100% to support accelerated approval.

Any thoughts?

BB