Amarin Corp (NASDAQ: AMRN) NCE status isn't update in FDA Orange Book for October
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Groundhog Day for Amarin (AMRN); MKM Not Positive on NCE Status Although Company Remains Upbeat
November 19, 2012 10:42 AM ESTAnalysts at MKM Partners commented on Amarin Corporation (NASDAQ: AMRN) after the FDA updated the Orange Book for October and once again failed to rule on NCE status for Vascepa.
MKM's Jon LeCroy notes this is the fourth delay and he assumes that it is unlikely that Amarin will be able to successfully petition the FDA to grant Vascepa NCE status. However,... More
Volatility to Continue for Amarin (AMRN) with No NCE Decision, But Serious Upside Exists - Jefferies
November 19, 2012 8:20 AM ESTJefferies commented on Amarin Corporation (NASDAQ: AMRN) after this month's FDA Orange Book update contained no decision on 5-year versus 3-year exclusivity for Vascepa.
While the firm expects more volatility with no NCE decision, Amarin's 10-Q, stating - "We have been informed by FDA that the FDA has drafted a proposed response letter to our exclusivity request, that such draft response letter has been circulated internally at the FDA for comment and the FDA has been considering the issue actively" - is a modest positive.
"There may be... More
Amarin (AMRN) Sees Downside Action
November 16, 2012 1:22 PM ESTAmarin Corporation plc (NASDAQ: AMRN) sees downside. NCE decision expected soon.... More
