Ann: MoU for Confirmatory Trial for GI Bleeding in LVAD Patients, page-4

Yep, this definitely spells it out: i.e. "confirmatory clinical trial "
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Mesoblast plans to meet with the FDA in the upcoming quarter to discuss an approval pathway for Revascor under its existing RMAT designation, which provides eligibility for priority review and accelerated approval. Mesoblast has received guidance from the FDA that reduction in GI bleeding and associated hospitalizations are a clinically meaningful outcome that can support marketing approval. Mesoblast will present the concordant results from the prior two trials, together with the plan for a confirmatory trial powered for the primary endpoint of reduction in GI bleeding