Yep, agreeing a trial protocol with the FDA will take a year... especially if they want to use it to validate the potency assay, but then I can't see how a single arm trial will help. SI said the FDA told them they shouldn't run another (single arm) trial until they had validated the potency assay. So I can't see how his current proposals "align" with that
Ann: Mesoblast Partners with BMT CTN on Adult SR-aGVHD Trial, page-33
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