smh
this shows how little some understand what they mean with CMC potency.
its not about the results of the trial, its the donor/batch/passage potential variation of potency
they dont have a strong way to test/control for this before dosing patients and dont know how the exactly measurements they are taking in vitro will directly impact the patients once dosed
the CMC issues will impact the other MSB indications as well
MSB to dispute FDA finding in Type A meeting, page-39
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