Amarin Corp Plc (AMRN)

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From SR's Instablog: New FDA Document Could Mean NCE For Amarin 2 comments
Apr 9, 2013 12:30 PM | about stocks: AMRN, GSK
A new guideline document for generic Vascepa issued by FDA (they opine by issuing these type of documents for all new and approved drugs) suggests two things:
1) They may be ready and willing to issue NCE, as the document specifies the active ingredient in a technically different way than on Lovaza's generic guideline document
2) Amarin's stated supplier/manufacturing barriers to entry may play a huge role in thwarting generics, as the FDA document includes specific API directives.
Stocks: AMRN, GSK
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bravo33Comments (42)
Steve,

Good comments on a document that has been discussed just recently on a limited number of other sites. One question I'm not clear on - is there any 'effective date' associated with this document or are its findings applicable, binding and enforceable now? Your second point regarding API directives sounds very significant. I take from your comments that you think this could translate into NCE yes very soon.

Thanks! 9 Apr, 01:49 PMReplyLike1

Steve RosenmanComments (472)
FDA issues the document as a general guideline when new drugs come to market, and can provide this type of document to would-be generic manufacturers - making no observation, determination or designation to any IP that the drug may have. In this case, the document is moot to generics, as AMRN's patents will not allow them to infringe (at least not without risk and liability).

Side note - I know of two generics (one top in the market and one a rather small player) that were looking to knock off Vascepa more than 1 year ago, they both have since abandoned their attempts and desire to go after Vascepa due to supply barriers causing the material to cost too much and due to AMRNs IP position. Forgetting the BS uncertainty talked about on Wall Street and in general, I am very confident AMRN will be the only Vascepa player for quite some time... The stock is only at this price b/c the big money is betting that there is more time to play with before the next leg up on AMRN begins again. This history has played out time and time again with AMRN and the big money supporters - just look at the charts relative to catalysts and news announcements. My take is we get a new multi-year high before Anchor approval.
http://m.seekingalpha.com/instablog/1282351-steve-rosenman/1737551-new-fda-document-could-mean-nce-for-amarin