Thanks for that Video...
Intersting on aGVHD too
Investigators did not want to do random trial so 241 EAP patients
Then FDA agreed to 60 patients open label, because it was unethical to use placebo
...
All if this is consistent with the current BLA & ODAC
So why did the FDA do a backflip now on requirement for RCT
Still baffled & upset by this whole event
Bring on the Type A meeting, we need to know more!!!
Mesoblast Company Update - Webcast and Forward Thoughts, page-159
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