This reopens a near-term approval path and restores a defined decision date, with the FDA expected to rule by Aug. 5, 2026. Moderna can now plan late-2026 US commercialization and manufacturing/launch commitments around a live review rather than a procedural refusal. The episode signals that pathway selection and comparator choices in older-adult flu trials can become gating issues, increasing the need for pre-aligned trial designs and supplemental analyses for 65+ populations.