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Small market for the drug too.

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14/07/20

11:57

Post #: 45849739
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Originally posted by SelmaBouvier: ↑

PXS It's not FDA approval, it's orphan drug status

Orphan designation qualifies the sponsor of the drug for various development incentives such as reduced regulatory fees and extended periods of market exclusivity. The granting of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and effectiveness of a drug must be established through adequate and well‐controlled studies.

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Small market for the drug too.
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