The significant differences being that Ruxolitinib was previously approved for other indiactions after successful phase 3 trials that achieved the primary end point, it has a validated potency assay and a well established mechanism of action. In contrast Remestemcel has failed to achieve the primary end point in multiple trials, has no validated potency assay, a theoretical mechanism of action and the only posive indicator was a small single arm open label trial after a comprehensive history of failure.
All points that affect the FDA's decision making process. Not surprisingly they have recommended a properly controlled trial that SI is reluctant to do.
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