Amarin Corp Plc (AMRN)

[Biobillionair]

Same document pg 16
"A preIND meeting was held on 14 July 2008. During the discussion, it was agreed that a single study could potentially suffice for the indication “as an adjunct to diet to reduce triglycerides in adult patients with very high >500 mg/dL triglyceride levels” provided that the results are robust. The agency defined robust results as: results that are statistically significant; results from a study with a low drop out rate; study results that are consistent across treatment centers; and results from a study with a large sample size. The Agency also confirmed requirements for NCE toxicology program."

"NCE toxicology"

Page 20
"The drug product from Amarin contains a purified icosapent ethyl. Icosapent ethyl (ethyl eicosapentaenoic acid or ethyl-EPA) is the ethyl ester of EPA. Icosapent ethyl acts as a prodrug for EPA, as it is hydrolyzed enzymatically by esterases, particularly pancreatic lipase, to liberate the free acid EPA"

"Prodrug" not EPA but prodrug Icosapent Ethyl....sound like NCE;)

Anchor study reviewed pages 28 to 41

Both efficasy and safety for Marine and Anchor in this review.
A review of the data set and the FDA should rubber stamp it. This document is new to my eyes, anyone know when the FDA posted it?