...actually, there was one other reference for external controls. The sponsor wanted to use a Placebo Arm of Tipifarnib Study 01-C-0222 Study 01-C-0222, a study which " was sponsored by CTEP and coordinated by the NCI POB" i.e. the very same sponsor seeking marketing approval for a different drug. The FDA thought this was OK. But not when MSB sought to use its own earlier randomised trials in the same manner.
Yep. We were special alright. Enough. That was then. This is now.
Cheers
Mesoblast stock(rock)-take March 2024, page-196
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