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Santa Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP4053) in Patients with Duchess Muscular Dystrophy (DMD) Amenable to Skipping Exon
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Accelerated approval is for drugs that treat serious conditions and fill an unmet medical need.
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To apply for accelerated approval, the manufacturer must submit data to the FDA for review.
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The manufacturer must report clinical trial data and evidence of the drug's effectiveness.
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