The FDA simply stuck to their recommendation. What was it again?
Let me help you. The recommendation that Mesoblast "should conduct at least one randomized trial in children and/or adults..."
Then someone started claiming that the FDA didn't really want better quality evidence, just "more evidence" and the "4 year survival data" would be more than sufficient. Then there was Dr Krause. How could he possibly be wrong? and so on and so on.
Ann: Update on BLA for Graft Versus Host Disease, page-131
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