Thank you @imback. Yes, I had gathered there were multiple contributing factors in FDA's change of heart and was unclear attributing it to one specific factor; namely change of FDA process/pricedure.
I personally hope the new decision was mostly influenced by data/response presented by MBS ... as that will put us on a better path in progressing/continuing with BLA ... and the adult lable extension (but im not going to walk ahead of myself by focussing too much on the adult lable extension at this stage).
Thank you @imback. Yes, I had gathered there were multiple...
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