Great post that involved a lot of detailed research & reasoning Stanjupiter. The more one reflects on the events of the past 3 years….the more confounding the outcome. The USA is the land of litigation. It is unclear after the latest CLR whether the EAP continues or not. If it has been suspended….and has been generating such prolific results as compared to SOC……surely there is a prima face case for a class action on behalf of young patients & their families who are forced to suffer a substandard treatment when a far more superior one is readily available ? Ryoncil has now been around for years…..proven to be safe & effective beyond anything else……it is not a ‘Frankenstein steaming soda’ yet it is being treated as such.
Ann: Mesoblast Type A Meeting with FDA, page-256
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