Mechanism: A neuro-repair therapy transforms inflammatory microglia into reparative microglia, promoting remyelination and neural regeneration. Readout: Readout: Myelin PET signal increases by 25% and clinical disability (EDSS) improves by 2.0 points, indicating significant neural repair.
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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