Honest question
Wasn't it the FDA that reached out TO Mesoblast and not the other way round ?
"United States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)"
Why would they do that ?
and doesn't that sentence above suggest that, specifically for the scenario mentioned, they are very much inviting Mesoblast to come back with the same submission ? or am I reading the tea leaves incorrectly ?
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