The 241 patients treated with Remestemcel-L through the FDA approved EAP for SR-aGVHD is a larger cohort than any trials undertaken by Mesoblast for SR-aGVHD so the data in its totality could be considered as that from an additional trial by the FDA ?
This data would most probably be designated by the FDA as data from an 'open label' trial under the circumstances but nonetheless data that would support the current phase 3 results... people don't seem to grasp this concept when they argue that the BLA resubmission is supposedly a non starter without even knowing all the data from these 241 patients ?
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