Dr. Cote describes the point at which companies with orphan programs should apply for orphan designation, including the criteria which make a drug candidate eligible for orphan status and the strategic considerations surrounding timing.
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Dr. Cote provides an overview of the ways in which second-to-market orphan drugs can receive the incentives of orphan designation (primarily exclusivity) by proving clinical superiority. He also explains the deciding divisions responsible for awarding the designation and the conditional nature by which orphan designation can be separated from exclusivity.
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