Healios KK Advances Global Phase 3 ARDS Trial - TipRanks.com
Healios KK (JP:4593) has agreed with the FDA to conduct a global Phase 3 trial, REVIVE-ARDS, assessing MultiStem therapy for ARDS, with Ventilator Free Days as the primary endpoint. The trial will include interim analyses at 300 and 400 patients, up to a maximum of 550 patients. Healios aims to discuss conditional approval in Japan based on Phase 2 results and the upcoming study.
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Healios KK (JP:4593) has agreed with the FDA to conduct a global Phase 3 trial, REVIVE-ARDS, assessing MultiStem therapy for ARDS, with Ventilator Free Days as the primary endpoint. The trial will include interim analyses at 300 and 400 patients, up to a maximum of 550 patients. Healios aims to discuss conditional approval in Japan based on Phase 2 results and the upcoming study.