Cost EfficiencyRoche will supply atezolizumab for the upcoming Phase 3 study, offering significant cost savings for Tempest.
Regulatory AdvancementThe company received FDA clearance to proceed with a Phase 3 study of amezalpat in combination with current standard of care, providing a significant regulatory advancement.
Study Timeline OptimizationThe FDA agreed on a statistical plan that includes a pre-specified early efficacy analysis, potentially shortening the study's timeline by eight months.