Amarin Corporation plc (ADR) (AMRN): Something Fishy? Or Business as Usual?

I have a feeling that many of the doctors on the panel will be OK with approving Vascepa with the current data. Its competitor, GlaxoSmithKline plc (ADR) (NYSE:GSK)‘s Lovaza, is already being used off label by some doctors, and Lovaza actually raises bad LDL cholesterol. Vascepa is relatively safe, too, so even if it isn’t reducing heart problems, it’s not going to cause too many problems before Reduce-It gives a definitive answer.

But the tone for the meeting — and the ultimate decision — will likely be set by the FDA reviewers ahead of the meeting when the FDA posts its briefing documents for the committee, likely on Oct. 11 because the usual time — two business days prior — falls on Columbus Day, a federal holiday.

The doctors on the panel might be able to change the FDA reviewers’ minds, but since the FDA has the final say, investors should pay close attention to the briefing documents.

The article Something Fishy? Or Business as Usual? originally appeared on Fool.com and is written by Brian Orelli.

Fool contributor Brian Orelli has no position in any stocks mentioned. The Motley Fool recommends Seattle Genetics, Inc. (NASDAQ:SGEN).

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