@col69 FDA's response doesn't make sense?
They want another trial with Adults included. Ryoncil is for Children thus the trial children only. Yes the number was low (55) and open label (there was a reason for that, obviously not good reason)
Efficacy 65% and no safety issues.
Also, manufacturing wasn't a problem.
FDA still not happy. I'm confused and it smells fishy!
MSB Trading 2020 - a new dawn, page-7805
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