EndtheFed, the Opdivo trial will not enrol any patients any more and OTHERS then those that have been treated with Opdivo (or where in a CT control arm) cannot be treated with it for months. This lowers enrolment competition for PPHM and will speed things up.
PPHM end enrolment in about 7 months (DEC 2015). The US centres are open since more then a year (actually between 14 and 17 months). So if we would assume that the availability of Opdivo would be in say 3 months (which would be EXTREMELY FAST) then those centres are opened 17 to 20 months. PPHM has plotted a worse case expectation of enrolment, so they have margins and furthermore we know they are on track WHILE OPDIVO WAS AVAILABLE as a competing clinical trail. So Opdivo didn't have much impact on the expected enrolment.
And yes, outside the US Opdivo will not be available and only 38 of the 158 clinical treatment centres are in the US.
But actually that will not be the differentiator. Opdivo is DANGEROUS. Getting your cancer cured and in the process die from an internal bleeding or inflammations makes no sense. Furthermore with its small responders footprint Opdivo is a serous GAMBLE compared to Docetaxel+Bavituximab, that in worst case gives you a Docetaxel treatment if you are in the control arm but certainly doesn't harm you if you are in the Bavi arm.
And Docetaxel+Bavituximab's 113% over SOC which was statistical significant, must on one hand be confirmed by the PIII SUNRISE but must also be beaten by Opdivo which remains to be seen.
In all cases NSCLC patients in ECOG 3 and 4 don't have much time to delay and think. They must act now and for now there is no Opdivo.
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