After completion of chemo-rad. About 4 months past diagnosis (median) IIRC.
But their trial numbers show OS from randomization., The argument here by longs is that NEBO should count OS from surgery and compare that to NVCR's post randomization numbers.
If it is right for NWBO to back up to surgery, why should NVCR not do so also? Hell, why not diagnosis? ATL claims it does not matter when you start counting, and dozens here agree.
longfellow95, I would like to get your feedback (or anyone else) on my message post below. I know that there are valid, scientific-based reasons that Dr. Liau et. al. only feel compelled to make an adjustment for only 1 of the external control arm (ECA) trials. That 1 trial is the Chinot et. al 2014 trial.
The only reason she felt compelled to footnote that 1 trial, and not the other 4 trials, was because that 1 trial was the only ECA trial that deviated from the SOC (tumor resection + 6 weeks of concomitant chemoradiation) for the control group. That 1 trial treated the control group with 3 weeks of concomitant chemoradiation, then added the treatment or placebo, then restarted the last 3 weeks of the chemoradiation.
Dr. Liau is trying to compare the DCVax-L treated group from the Phase III trial, with ECAs that were only treated with SOC.
In the real-world, ndGBM patients are not randomized to a treatment and a control group. They are all treated with SOC. With SOC, ndGBM patients Overall Survival (OS) is measured from after surgery and before the start of the 6 weeks of concomitant chemoradiation treatment.
This is the exact same way OS is measured for the DCVax-L treated patients in the Phase III trial. There is no need to adjust for randomization differences, unless the there is a deviation from SOC, like in the Chinot 2014 trial.
I know that Ex is a "self-proclaimed" and "self-appointed" "expert" on these matters, but I am going to stick with the real experts (Dr. Liau & the 68 other surgeons, doctors & scientists).
I am also going to stick with my research and due diligence. I am also going to go on record and state the following:
NWBio, Dr. Liau and the 68 other authors, will not make any randomization adjustments to the DCVax-L Overall Survival (OS) results that will be published in a top tier, peer-reviewed medical journal, and they will not make any adjustments to the OS numbers they will submit to the FDA and the 3 other RAs, because no adjustments are required or needed.
This is only an attempt by shorts, FUDsters and other naysayers to try and downplay and dilute the strength of the DCVax-L trial results for OS. Dr. Liau is not falling for this plot, and neither am I.
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