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With regard to the substantial clinical improvement criterion, the applicant asserted that omidubicel represents a substantial clinical improvement over existing technologies because the totality of the data (up to 10-year follow-up) powers the evidence that omidubicel, which would be the first patient-specific advanced cellular therapy donor source, meets a high unmet treatment need for a diverse group of patients with serious, life-threatening hematologic malignancies and provides high quality stem cells, clinically meaningful and highly statistically significant clinical improvement, lower healthcare resource utilization, with an overall favorable benefit/risk profile