After Leftyahoo’s post …..from my understanding……that if MSB had applied for a trial after OTAT/CBER meetings last year when the potency assay was considered acceptable we would not be in this position but they continued with the original BLA which according to FDA needed more data
So that was the inflexion point that if they successfully applied to the FDA then for a trial and progressed from there
CEO Itescu needs to go, page-29
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