NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

With respect to the "patient level matched control data" of the ECAs, requested
by the FDA to be included in the BLA, it should be pointed out that the fact
that the mOS of the unmethylated GBM treatment group of the DCVax-L trial
was not statistically different from the mOS of the unmethylated GBM patients
of the ECAs, should have greatly diminished the need for patient level matched control
data. The similarity between the mOS of the treatment group to the mOS of the
comparable population in the ECAs, shows that the inclusion/exclusion methodologies
of the DCVax-L trial was a good match for the inclusion/exclusion policies of the
ECAs.

Stop being so reasonable and logical. I know I know. There is, almost, no need for individual patient-level data the summarized patient-level data should suffice. Worse. Why would the FDA want to see a control group? Everyone is different. If the FDA is so hell-bent on having a fair comparison then they should demand the sponsor to randomize twins with both GBM with equal lifestyles one for placebo and the other in the treatment. Its absurd its insane. Especially when the treatment arm has in and exclusion compared to GBM soc as with the DCVAXL trial. But you don't have to convince me Its the FDA
that needs to be reasoned with.

I for one do not trust that okay its so unreasonable therefore sure sure the FDA will accept NWBO's BLA.