Amarin Corp Plc (AMRN)

[Biobillionair]

The minimum exclusivity Vascepa will be granted is 3 years at the point of Anchor approval. The Exclusivity designation is NME 3 yrs, awarded to a compound that's been approved for a new indication completing a clinical trial. The designation used in the Performance report NME has a separate definition given on page 67. "NME – New Molecular Entity" it's definition is a chemical compound never approved before. It has NO reference to NME 3 yrs, In this document. The FDA appears to have ruled Vascepa is NOT novel, despite USP considering Lovaza as a mix of seven Omega 3's, separate CAS numbers, and numerous PubChem references.

Should you panic? No

NME Exclusivity will be awarded because of Anchor Trial (new clinical trial and indication) in fact no exclusivity for Marine is telling that the FDA will approve Anchor. December 2013, 2014, 2015....January 2016 generic competition if they can get by the MASSIVE IP.

NME Exclusivity might not be awarded for a combo product considering it would still be the same indication. NME 3 yrs Exclusivity can be awarded for REDUCE-IT though...

Why am I so pissed?

1) The FDA harmed Amarin and shareholder with their horrible communication.
2) Amarin should have been allowed to combine Marine/Anchor into one approval cycle, what a waste of resources.
3) Amarin's review raises many red flags of FDA indiscretions.

----3 yrs NME at Anchor approval---I disagree, but this document leaks the decision IMO.

Williams