Mesoblast (ASX:MSB) requested a Type B meeting with the US Food and Drug Administration to discuss the accelerated approval pathway for its drug candidate, Revascor, in treating ischemic chronic heart failure, according to a Thursday filing with the Australian bourse.
The meeting will focus on key aspects of the approval process, including manufacturing, potency assays, and confirmatory trial design, the filing said.
The meeting is expected to take place this quarter, the filing added.
Shares of the company fell nearly 2% in recent Thursday trade.
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