Pyrrhonian,
My last post was indeed unclear as to my thought process. First, let me say that I do understand all about post hoc analysis and that using post hoc data is not at all what I was aiming to suggest but perhaps came across that way. Secondly, I also understand that until there is clinical proof, evidence can be extremely positive but is not sufficient. This means that SOC comparisons, that lead to earlier deaths than "evidence" might suggest treatment arms would produce (OS treatment benefit), are many times necessary to obtain this proof. This has been one of the main ongoing debates here regarding PFS and OS.
My hope from posting was to suggest, as others have, that PFS might be good on its own. Just to be sure for the trial's sake, though, I wondered if there might be room for NWBO to amend the protocol with regard to mesenchymal GBM. I have not seen the complete protocols nor the ammendments as exactly written out so I don't know if the mesenchymal group was ever written in for potential analysis. My due diligence suggests they may have been accounted for at some point in this very long process but I can not be certain. If they are being accounted for, I thought NWBO might have the option to potentially reduce trial failure risk by submitting only their best open label and preclinical evidence. They would have about 100 mesenchymal patients and .03 spend to work with right? My question is could they make this work? I don't know for sure because I am not a statistician but if they have this option to consider, so do we. I am not a clinician either but with all the protocol changes that have happened in this trial, I thought this was a change that others were aluding to even though I had read some comments stating that this type of change would require a whole new trial. I thought perhaps these comments insinuated that the reserve spend was large enough that a new trial might not be necessary. Sorry for the confusion. Best wishes.
