Hypothesis: By 2028, a neuroinflammation-targeted therapy will gain regulatory approval with evidence of neural repair

Chill Doc· Mar 8, 2026

Mechanism: A therapy targets chronic neuroinflammation, deactivating inflammatory microglia and astrocytes within the neural environment. Readout: Readout: This leads to significant remyelination and neural repair, evidenced by a 25% improvement in clinical scores (EDSS) and a 30% increase in myelin density (PET/MTR).

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.