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Biobillionair

07/23/14 12:57 PM

#31037 RE: ralphey #31030

"The PDUFA is in limbo"----in January, when the FDA, affirmed they won't reinstate Anchor SPA...the PDUFA was done...right? The PDUFA date was the sNDA...instead of calling a meeting and not accepting Anchor sNDA...the FDA needed the time and surprise to maximally damage Amarin stakeholder. This is the only explanation into the "capricious" action taken by the FDA from the start of 7-26-2012 approval.