Seeking Alpha

Summer Street weighs in on the FDA's delay of Auxilium's PDUFA date for Xiaflex; advises caution

  • Summer Street weighs in on Auxilium's (AUXL +6.2%) announcement that the FDA extended its PDUFA date of the company's NDA for Xiaflex, saying they remain pessimistic on FDA approval and believe the agency won't approve the application without holding an advisory committee meeting.
  • The PDUFA date was extended 3 months to December 6th because a late submission of information was classified as a major amendment to the NDA.
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