As I understand, MSB made the announcement on 27th of August 2019 as following:
FDA confirmed that data from the recently completed 159-patient placebo-controlled trial showing that Revascor reduced major mucosal bleeding events can support product marketing authorization through a Biologics License Application (BLA), with confirmatory clinical data.
If the confirmatory data is provided, we might get BLA for Revascor which has a successful rate of 90%.
Ann: DMC Completes Final Review of Phase 3 Heart Failure Trial, page-43
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