NorthWest Biotherapeutics Inc (NWBO)

[koman]

I have got to say that all this talk of pseudo progressive vs true progressive sub groups really complicates things for rGBM and designing a proper trial, So far all the papers I read about these two groups uses medOS to measure the difference between them and no mention of any PFS of any kind, and the difference is a whopper of about 10mth vs 27mth. The general protocol seems to indicate that at least three months from time to progression after SOC is what it takes to differentiate the two groups using MRI scans. The psPD will show stabilized tumors, whereas the tPD will show progression using whatever criteria (rano or macDonald- no mention of recist unless the former two are extensions of recist.) What I don't know is whether NWBO waited 3mths before giving dcvaxL to these compassionate patients so that these sub groups can be distinguished? Also, isn't there a chance that this differentiation will also affect the ndGBM trial somehow? Also, I have to assume that even the psPD sub group must eventually show progression for mortality to occur, but is PFS a metric that is not appropriate for rGBM or even ndGBM considering there are papers showing researchers seeing no medPFS advantage but a large medOS advantage in a small but ctrled pII trial in ndGBM. This is sort of why I really didn't like to see the cross over put into the pIII trial for dc-vax-L because it will affect the interpretation of any medOS data that comes out of it. This is turning out to be one messy situation and I do believe that dc vaccinations work but it is a matter of proving it to the FDA in a well designed and executed trial. I still want to hear from Dr. Bosch tomorrow and hear if he will talk about any PFS metrics for the 51 and any sub groups from that group even if there is no ctrl for them- any CR any PR or even how long the SD was in the psPD etc. This stuff will give anyone a headache trying to over think it. Anyway, what a market today was. I wonder if mr. market is going to self fulfill their prediction of a bio sector correction in the coming months. Stay tuned for market volatility going into all these upcoming positive events for NWBO.