aren't MSB seeking approval from FDA with this?
Mesoblast Chief Medical Officer Dr Fred Grossman said: “We expect the mortality benefit observed in
this seminal Phase 3 trial will support a potential path for approval of rexlemestrocel-L in patients with
advanced chronic heart failure. We are planning to meet and discuss potential pathways to approval
based on mortality reduction with the United States Food and Drug Administration.”
Ann: Mesoblast Phase 3 Chronic Heart Failure Results, page-166
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