Replies to post #696506 on NorthWest Biotherapeutics Inc (NWBO)

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Designated Orphan Drug or Indication: An application for a prescription drug product that has been designated as a drug for a rare disease or condition under section 526 of the FD&C Act is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.May 3, 2024
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Prescription Drug User Fee Amendments | FDA