Hi stockrock! I understand what you have posted to be true re: FDA recommendation to MSB RCT for SR-aGVHD disease.
Do you or anyone know if there has actually ever been a RCT on children aged 0-11?
Has the FDA or NIH {sponsored) been actively involved in such trials of children aged 0-11?
Some of the experts at ODAC seemed to think such trials being requested by the FDA are not realistic & other methods need to be sought.
I have great faith that Ryoncil will be approved... just impatient for commonsense to prevail
AGM Discussion, page-108
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