biopharma, Please provide the link to where PPHM built in margin. I have looked and I cannot find that statement or anything close.
My recollection is perhaps the conference call from Dec '13.
What I recall hearing was that they powered the trial at an MOS of +2 months over SOC, but they really expected better results than that. It is very reasonable to be conservative on powering assumptions, so nothing unusual in that.
As far as SUNRISE results, all that would mean is that the "expected MOS" that the Bavi arm matched would be a couple months or so above the powering assumptions. It does not in any way change the core fact that Bavi was not trending well vs the placebo arm.
If (for example, as we obviously do not know numbers), the trial assumptions were 10 vs 8 mos, but they really expected Bavi to hit 12 months. Then the results came in at 12 vs 12. So what? The arm median OS on its own means nothing. Only the comparison to the other arm.