Though I share your general optimism, your post is a bit...

Though I share your general optimism, your post is a bit misleading in my eyes:
Phase II in GBM reported data vs a historical control arm.
If paxalisib repeats its performance in GBM AGILE and if PFS and more importantly mOS are similar to those observed in TMZ‘s pivotal study which Kazia used as reference, 12.7 months if I recall correctly, then there is very little in the way of paxalisib’s FDA approval in newly diagnosed, unmethylated GBM.
But mOS for TMZ was quite a bit higher in other studies in the same indication, reaching 15 months. The closer TMZ gets to these values in GBM AGILE the less likely will it be for paxalisib to secure FDA approval in this indication.

And though the threshold GCR uses to determine if a drug in GBM AGILE graduates to Stage 2 is not known, it is not far fetched to assume that the difference between both treatment arms won’t be huge. (Admittedly having refractory patients in the same treatment arms confounds the matter somewhat.)