I think it’s a great trial design. Allows running of a placebo arm without any ethical considerations - all patients will still get the standard corticosteroid treatment so would be no more disadvantaged than patients not in the trial.
However would still suck to be one of those unlucky ones to be in the trial but lose the coin flip and miss out on the stem cell therapy.
I wonder if there’s a small chance there’s plans to go for an approval application with the FDA if the p2 trial is successful - I know crazy idea.
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