Mesoblast (MESO) said late Wednesday it expets to have a type B meeting with the US Food and Drug Administration during the current quarter to discuss the accelerated approval pathway for ischemic heart failure treatment candidate, Revascor.
The main goals of the meeting are to get FDA feedback on relevant chemistry, manufacturing & controls, alignment on potency assays for commercial product release, and the company's proposed design and primary endpoint for the confirmatory trial, it said.
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