Cell Therapy News/Articles, page-17335

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.