Healios KK (JP:4593) has released an update.
Healios KK has reached an agreement with the FDA to proceed with a pivotal global Phase 3 clinical trial, named REVIVE-ARDS, to evaluate the efficacy and safety of their MultiStem therapy for ARDS. The study will use Ventilator Free Days as the primary endpoint and includes interim analyses at the 300 and 400 patient milestones, with a maximum of 550 patients. Healios plans to discuss conditional and time-limited approval in Japan based on previous positive Phase 2 results and the upcoming confirmatory study.
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