Comment from National Brain Tumor Society and Society for Neuro-Oncology
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Summary: The National Brain Tumor Society and the Society for Neuro-Oncology support the FDA's draft guidance on the Plausible Mechanism Framework as a positive step for rare disease treatment. They highlight the complexity of brain tumor biology and urge the FDA to collaborate with researchers to determine how the framework can best be applied to these complex cancers.
See attached file(s). National Brain Tumor Society and the Society for Neuro-Oncology write to provide comment on the draft guidance for industry related to the Plausible Mechanism Framework. We appreciate the FDA's consideration of our views and stand as a resource to the FDA as it considers future application of the guidance to sponsors in the field of neuro-oncology and brain tumor treatment.