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Drug Approval Standards Cardiovascular Review Pathway

Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients

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Executive Summary

US FDA agrees to plan to seek approval for ‘off the shelf’ cell therapy with Phase II data showing fewer major mucosal bleeding events in end-stage heart failure patients implanted with mechanical assist devices; confirmatory Phase III is set to begin this year.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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