Amarin Corp Plc (AMRN)

[johnking29]

Nads: Here is a better way to look at it... From Seeking Alpha many months ago (before you ever heard about Vascepa:)

NCE Status

According to the FDA code, "New chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act." In this definition, approved refers to the active ingredient either "alone or in combination" with other elements. If granted NCE, Amarin will get exclusive marketing rights for Vascepa over the next five years. An important factor in deciding whether Vascepa should receive NCE status is how it compares to the drug Lovaza. According to the FDA's drug database, the active ingredient for Lovaza is "Omega-3-Acid Ethyl Esters." A one-gram capsule of Lovaza contains at least 900mg of the active ingredient, which is delivered through fish oils. Meanwhile, Vascepa contains a "a prescription-grade omega-3 fatty acid, containing ultra pure EPA (icosapent ethyl)." If Amarin can be listed with "Ethyl-EPA" as the active ingredient instead of "Ethyl Omega-3 Acids," the chances of getting an NCE for Vascepa will increase.