A reoccurring theme here is that scientific RCT's seem incapable of establishing weather the cells are of benefit or not, and only seem capable of examining the primary end point that is selected. The failure reasons have nothing to do with the efficacy of the treatment and 100% to do with the selection of the primary end point.
As the FDA says - if the primary end point is not met then all secondary end points cannot be considered. That is the scientific method?
Maybe they should change the primary end point to - 'treatment improves patients health'.
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