Amarin Corp Plc (AMRN)

[Biobillionair]

Chuck
"New Molecular Entity (NME)
A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form."

http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#NewMolecularEntity


At minimun Vascepa will be granted 3 years of Waxman-Hatch. Sometimes known as 3 yrs NME (Business definition)...often confused with the NME (New Molecular Entity never approved before drug definition).

"A 505(b)(2) application may itself be granted 3 years of Waxman-Hatch exclusivity if one or
more of the clinical investigations, other than BA/BE studies, was essential to approval of the
application and was conducted or sponsored by the applicant (21 CFR 314.50(j);"

The 2012 Congressional Report references Vascepa as a "NO" for NME (New Molecular Entity never approved before). Amarin should claify this with the FDA. Some argue the "NO" is a nondecision...maybe...maybe not.

My hunch is, the FDA with grant 3 yrs of W-H at Anchor approval and the FDA leaked the info by mistake, certainly woundn't be the first time.

It's telling Amarin has remained this quiet, I'm guessing Partnership/BO are as hot as ever.