Mechanism: A neuro-therapy reduces chronic neuroinflammation by deactivating inflammatory pathways, leading to neural repair. Readout: Readout: Myelin integrity improves by 40% and clinical function shows a 25% improvement on validated scales.
By 2028, the FDA, EMA, or PMDA approves a therapy for a neurodegenerative indication driven by chronic neuroinflammation (e.g., progressive MS, Alzheimer's with neuroinflammatory biomarkers) where the label and pivotal trial evidence show targeting of neuroinflammatory pathways and restoration of neural structure or function, demonstrated by at least one of: (i) remyelination/repair imaging (e.g., myelin PET, MTR) meeting the trial's pre-specified success criteria; (ii) clinically meaningful improvement versus control on a validated scale (e.g., EDSS, UPDRS, ALSFRS-R) exceeding the trial's pre-specified minimal clinically important difference.
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