How can the new control arm be taken seriously? There's clearly variable dosing between multiple patients - some getting docetaxel only, some getting the trial designed regimen of docetaxel and bavituximab and some getting a strange mix of both the control arm and 1mg/kg regimens.
I mean, how does one compare the two arms when one (the new combo) arm wasn't consistently dosed?
It would seem that comparing the results to the historical data (given that the multiple trial arms had variations in the parameters they controlled), but especially taking into account how sick the patients were in each of the docetaxel only arms, would better demonstrate the achievement of the 3mg/kg arm - in a FWIW sort of way - like the Indian NSCLC n=49 trial did.