Hi DD,
Any feedback re these thoughts
My mind says - if efficacy is proven, then JB's points re small n and confounding variables are no longer valid , in terms of getting approved.
If the adult trial is on hold, then there is agreement that the 001 pediatric data may be enough to get approval.
Potency must be proven,imo, in the 001 trial product- as no further trials ( review process) were to occur until agreement or else why would the review be back on?
The announcement to refile specifically said after additional consideration of the data from the 001 study- not any other part of the BLA submission.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-730
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