Replies to post #11243 on Amarin Corp Plc (AMRN)

[BiotechWill]

Your entire basis here is quite misleading - there are no lies in there - and you are entirely confusing the process of how NCE status is granted, with how a NDA is filed and a PDUFA date comes about. That is actually very misleading, as whether the NME status granted for NDA review by CEDR is an entirely different process than the review for NCE status conducted by the FDA.

From the FDA website:
"FDA’s classification of a drug as an “NME” for review purposes is distinct from FDA’s determination of whether a drug product is a “new chemical entity” or “NCE” within the meaning of the Federal Food, Drug, and Cosmetic Act."

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm336115.htm

[sts66]

I did get the impression the Lovaza petition was holding up Vascepa's exclusivity.

I still fail to see how the two are related....