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Incyte Corporation Message Board

  • maddison3 maddison3 Jul 13, 2011 9:14 AM Flag

    Has NDA been accepted

    Since it was filed on June 6th...the company should know.....FDA has 30 days to notify company... Hopefully they will let us know shortly.

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    • Thanks for the info. I stand corrected in my previous statement

    • Quoted from the Incyte press release on the NDA submission:

      About the Regulatory Process

      Upon the submission of the NDA, the FDA determines if the application is considered filed after reviewing the submission for completeness and accepting it for review. This filing decision is typically made within 60 days of receiving an application. Assuming the NDA is considered complete and accepted for review, it will then go through a detailed FDA review process through one of two systems of review times: PriorityReviewand Standard Review.


      We see from this that they aren't REQUIRED to make the filing decision on a specific time scale, and the typical time isn't up yet.

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