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Threshold Pharmaceuticals Inc. Message Board

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  • pharmajedi pharmajedi Mar 15, 2012 12:52 AM Flag

    Orphan drug status = Fastrack NDA Approval

    Not quite......approval as an orphan drug (orphan drug status) occurs when the marketing application is submitted (NDA) by the sponsor. Orphan status has nothing to do with allowing clinical trials. The drug is clearly designated to treat an orphan disease, however formal approval occurs (if qualifies) at the time of NDA, which then all benefits kick in assuming approval.

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