Amarin Corp Plc (AMRN)

[Biobillionair]

Genius, Lets go over Anchor facts first.
SPA study designed by the FDA and Amarin, it met all primary and secondary endpoints. This is success for efficasy. It had no safety issues. Finally none of the data has been subjected to any accuracy issues. All efficasy and safety data for Anchor is included in the Marine review documents, efficasy and safety for Marine has been approved.

So, the what are the possible show stoppers? In my opinion it would be some new found medical issue that raises questions about the safety or benefit of the drug or indication. Like the Niaspan study? In my opinion the Niacin study has ZERO effect on Anchor.
http://www.nih.gov/news/health/may2011/nhlbi-26.htm

Niacin lowered LDL, raised HDL and did jack for CV outcomes.

Does the AIM HIGH NIH study relate to "fish oil"? No Niacin and Vascepa have two separate mechanism of action. The "fish oil" hypothesis is related to EPA:AA ratios. Yes both Niaspan and Vascepa do a lot of similar lab value changes, but Niaspan does nothing to the EPA:AA ratio. The AHA has risks stratification for CV disease and who should maintain trigs less than 500, the Anchor indication. This is the medical need, and one dope cardiologist can't change this, nor can the FDA. Is there a medical need for the treatment of trigs 200-500, yes according to MANY cardiologists.

The failure of niacin does nothing to the medical need, it did raise question to the importance of raising HDL, which has nothing to do with Anchor.

This is the Pre-PDUFA game, that's it. Anchor's chance of approval is very high.

Williams

PS Adam couldn't pass a 10th grade biology final today, don't trust his scientific judgement.