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Friday, 12/20/2013 6:04:34 AM

Friday, December 20, 2013 6:04:34 AM

Post# of 427035
FDA Delays Amarin Decision

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The FDA also communicated to Amarin that it now views Amarin's appeal of the ANCHOR SPA agreement rescission and the ANCHOR sNDA as separate administrative decisions worthy of separate consideration. FDA plans to complete its review of Amarin's request to re-instate the ANCHOR SPA agreement and plans to convey its decision to Amarin no later than January 15, 2014. The FDA provided no additional information on when it expects to complete its review of the ANCHOR sNDA.
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