Ann: LVAD Trial Results Provide Potential Regulatory Pathway, page-56

This is the part that SI and the rest of the group will highlight and focus on, in the upcoming conference call:-

“Under the RMAT designation, Mesoblast received specific guidance from the FDA that reduction in major GI bleeding episodes and related hospitalizations in the current trial is a clinically meaningful outcome with a high unmet need that could meet requirements for an approvable regulatory endpoint.

In contrast, the FDA advised that the primary endpoint in the current trial of temporary weaning from full LVAD support is considered a biomarker and is not a clinically meaningful outcome in and of itself”

This is an overreaction by a market that clearly requires further clarification and guidance.