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Impax Laboratories Inc. Message Board

  • callstothewall callstothewall Jan 24, 2013 11:14 AM Flag

    Hayward Inspection from IR

    Received this e-mail from IR this morning.

    As the press release indicated, a satisfactory re-inspection in Hayward is required before the FDA will review/approve RYTARY’s NDA. Following a re-inspection, the FDA will review RYTARY’s development data (that came from Hayward). Depending on the outcome of that review and discussions with the FDA will we know the timing and approval status of RYTARY. At this time, until we can discuss the CRL with the FDA and there is an inspection, there isn’t any other information we can share. We don’t know the FDA’s timing on inspection or review.

    As for an inspection in Hayward, the FDA doesn’t provide notice of when they will arrive for an inspection, they just show up. We have previously stated that we will publicly announce after the FDA has completed their re-inspection of the Hayward facility and we have received information from the FDA on the outcome of the inspection.

    Mark Donohue

    Sentiment: Strong Buy

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