The FDA has extended the Prescription Drug User Fee Act date for NT-501, an encapsulated cell therapy for macular telangiectasia type 2, to March 18, 2025. Neurotech Pharmaceuticals provided additional data to the FDA for review, leading to the extension. The CEO of Neurotech, Richard Small, expressed commitment to providing any necessary information for the FDA’s review process. Two phase 3 trials of NT-501 previously met the primary outcome of ellipsoid zone loss, as measured by OCT. This development reflects ongoing efforts to bring this therapy to patients with macular telangiectasia type 2.
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FDA extends Prescription Drug User Fee Act date for macular telangiectasia type 2 therapy
