The primary endpoint of NVCR's EF-11 trial was PFS. For the rGBM setting the FDA has been allowing that endpoint. It was clearly met so the trial was a success.
One can fairly argue that PFS w/o OS is questionable, but that is up to regulators to decide.
For nGBM, where NWBO is, the NVCR EF-14 trial was highly stat sig for OS between the trial arms despite crossover.
Yes, re Optune, there was basically no significant OS benefit, and that WAS in fact the primary measure, and yet it was approved…and the same shorts constantly post nonsense here about DCVax-L.
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