The simple reason that MSB has not done the trial that FDA has requested (many times) is that such a trial has already been done: by Osiris.
And guess what: the product failed to meet the endpoints (the data is all published: A Phase 3 Randomized Study of Remestemcel-L versus Placebo Addedto Second-Line Therapy in Patients with Steroid-Refractory AcuteGraft-versus-Host Disease).
That means it didn't work. It might well work in children but MSB was never going to repeat a study that would doom the product.
CEO Itescu needs to go, page-181
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