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ggwpq

08/14/19 3:01 PM

#208855 RE: Biobillionair #208839

Amarin wouldn't win that in court. The FDA has the right to issue a 3-month PDUFA delay as certain info submitted by AMRN during the sNDA review process could be considered an amendment to the orginal sNDA hence warrant a 3-month delay based on FDA guidelines.