I have made the same observation regarding the Primary Endpoint shortfalls and it begs the question of why such aggressive endpoints are chosen for these studies. Why not simply choose the most attainable endpoint that would result in an economically feasible commercialization after approval? I am not familiar with the process for selection of endpoint objectives in a clinical trial but it almost seems that these endpoints are purposely predetermined to be nearly impossible to achieve. and we are seeing this play out repeatedly. is the FDA or some player in the trial development process just protecting the commercial interests of other entities that would be damaged by an approval of Mesoblast products?
Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics, page-116
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