Galleri timeline
Current statusFDA advisory review remains distinct from approval. GRAIL now forecasts an early Q1 2027 FDA decision; no exact agency date or approval is established. The combined stage III/IV primary miss and unproven mortality benefit remain explicit.
09 / 11
Occurred4 Nov 2026sponsor development/timing disclosure
GRAIL now forecasts a Galleri FDA decision in early Q1 2027
GRAIL forecasts an early Q1 2027 FDA decision. This is sponsor guidance, not an FDA deadline, approval or proof of mortality benefit.
Step 9 of 11
Evidence limitations. Finding more cancers, shifting stage and reducing cancer deaths are different outcomes. A favorable secondary stage IV result does not reverse a missed primary endpoint or establish a mortality benefit.
Dated events are ordered; spacing is schematic. Undated steps have no fixed timing. · Checked Nov 6, 2026. Read the topic research