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  "notes": "Mentions specific regulatory bodies (FDA, EMA) and clinical criteria (cIMPACT NOW, RANO-HGG).",
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      "text": "Homogenously defined population in recurrent diffuse midline glioma, H3 K27M-mutant, as defined by cIMPACT NOW Update 2, may be acceptable for approval\nFDA acknowledged that “available therapy” is considered palliative (i.e. there is no available treatment for recurrent H3 K27M mutant diffuse midline glioma)\nFDA acknowledged integrated safety database of approximately 350 patients\nApproval may be granted based on Overall Response Rate (ORR) by RANO-HGG\nBased on FDA discussions, the registration cohort will be comprised of 50 subjects pooled across multiple company-sponsored clinical studies and expanded access\nInitial EMA discussions have indicated durable ORR may be an acceptable endpoint for EU marketing authorization",
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