For sure if they have stat sig on PFS and OS and no confoundment, that is the way they will go. But you really can't PR a firm intent to file a BLA, unless what you say about your endpoints is unequivocally in line with that.
I can't wish away the possible impact of pseudo-progression on PFS and crossover on OS. As far as we know, PFS is still the primary with most or all of the alpha spend. And we don't know the upshot of the adjudication process. That doesn't mean that I think these issues are insurmountable, but I do think they are issues.
That why I said months ago that an element of ambiguity in the topline wouldn't totally surprise me, even though it will present positively.
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