AMRN’s meeting with the FDA regarding the Orange Book signifies nothing in particular, IMO. It’s a newbie mistake to assume that such a meeting implies that the drug in question will be approved on or before the PDUFA date.
Why AMRN's outcome study does NOT automatically equal NCE...
Amrns argument that an outcome study = NCE is BS.
Look at Omthera..They are also required to run an outcome study for 250-500 TG population...And there is NO way there drug would ever be considered to get NCE....
IMO this mtg everyone is talking about = Bearish for NCE...
However, I think to much importance is being put on the NCE designation due to the major strides AMRN has made on the patent front.
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