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Re: Biobillionair post# 208839

Wednesday, 08/14/2019 3:01:05 PM

Wednesday, August 14, 2019 3:01:05 PM

Post# of 428987
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.
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Volume:
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  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
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