I would assume that ORR precedent you cited was assuming statistical significance, right? Even the original ORR data presented on Sept. 7, 2012 was not statistically significant (.2069).
And do you know why the placebo group didn't even have a p-value assigned to it? I found that strange.
I highly doubt payors would agree to reimburse a drug that uses a statistically insignificant surrogate endpoint that was approved under accelerated approval. What a mine field this process is with so much fuel for the shorts. Fargo screwed us royally. All IMO.