banter and General Discussion, page-4701

My question is - why don't you show how you have considered the above, in forming your opinion that you believe there is not enough evidence to approve.


They aren't the only things the naysayers don't consider @reginaldp ... like I said recently, what about the additional data now at hand for the 241 patients that have been treated through the FDA approved EAP ?


The phase 3 trial for sr-aGVHD only treated 54 patients .... can you imagine the enormous amount of additional data Mesoblast are now about to hand to the FDA with the BLA resubmission from the 241 additional patients Mesoblast have treated through this EAP ?


How one can assert such opinions without knowing the full extent / breakdown of this additional data from these additional 241 sr-aGVHD patients being submitted to the FDA is beyond me but yet here they are most days telling us how it is a non starter ?


Like I have said previously, I believe Rose, Krause and Itescu have it under control .... I mean they have seen more information / data than the anonymous brigade of experts on HC after all - just sayin'





https://clinicaltrials.gov/ct2/show/NCT00759018?term=Remestemcel-L

_{Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD}