Just design and run a proper trial. It is really simple. This will get shredded to pieces in any kind of advisory committee. That's why LP sold off Cognate and took flight to another continent to build yet another CDMO. Time and resources to design and run a proper trial are not on NWBO's side since they focused years and years and $$ on the business of funding CDMOs for the CEO and Toucan.
Building CDMOs for LP is what nwbo is all about, all this other stuff is noise.
Once the trial effectively became single arm, and with no ECA patient level characteristic similarities, the trial was compromised. Do not discount the screening selection of only the "healthiest" patients in order provide enough time for L to kick in and to monitor for PFS.
BS. While the inclusion/exclusion criteria of the DCVax-L trial may have been somewhat different from those employed by the ECAs, the results demonstrate that the mOS of the trial patients would not have been significantly different had none of them received DCVax-L.
This is clearly shown by the fact that the mOS of the unmethylated GBM Treatment patients (16.9 months) was not significantly different than the mOS of the ECA's unmethylated GBM patients (16.5 months). Furthermore, over 6% of the unmethylated GBM trial patients survived more than 5 years whereas there was no record of any of the more numerous ECA's unmethylated GBM patients living that long. This suggests that the beneficial effect of DCVax-L may have somewhat increased the survival of many shorter living unmethylated GBM treatment patients and had those patients not received DCVax-L, their mOS would have been even shorter than 16.9 months.