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Xenoport, Inc. Message Board

  • ivoroshea ivoroshea Apr 6, 2011 7:26 PM Flag

    Is it just me ...

    ... or am I the only one to consider that a legitimate reason for delaying the PDUFA announcement is the partnership deal with GSK?

    For instance :

    * Might a common statement have to be agreed which inevitably takes time?

    * Might GSK have sole control over announcements (particularly after their deal was restructured last year)?

    * Maybe with GSK being a British company (with a 5 hour time difference) can't be bothered releasing press statements after midnight local time?

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    • I doubt it. The FDA works on its own and is not influenced by corporate actions. XNPT not releasing the news indicates to me its not positive. Last example that was exactly like this was orexigen (OREX). PDUFA date came and went, and next morning at 6am came the press release and stock went from 10 to 4 that day.

      • 1 Reply to axp72
      • Actually, I was more saying that the FDA could well have faxed the news to Xenoport by now but the licensing agreement with GSK gives GSK control over how the public announcement (approved, CRL or delay) is made.

        I came across an example of this with the Canadian biotech Bioniche who had ceded complete media disclosure to their partner, Endo Pharmaceuticals, of the outcome of a Phase III trial in bladder cancer.

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