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).
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