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sharinky

08/29/19 6:53 AM

#211698 RE: marzan #211693

If the delay in AdCom is due to poor scheduling on the FDA's part and not due in part to something Amarin did, you will not see a delay in PDUFA date. The FDA will just fail to meet their obligation. Their goal is to make a decision on 90% of their applications. Jt just told us yesterday the AdCom is in November.