SecureInvest,
You are right about this endpoint being of utmost importance. It was originally a secondary endpoint that took on added significance because of pseudoprogression and the crossover trial design. Funny how what used to be a bear argument against success, PFS and crossover, turns out to now be a strength for measuring effect in rGBM because pseudoprogression to crossover may be found to actually more beneficial and since many crossed over from treatment and placebo, the numbers should be very compelling. Believe it or not, though, many of us credit Dr. Linda Liau and other researchers for pushing the NWBO DCVax-L Phase 3 trial to the forefront as an example of the need to adequately catch the full impact of treatment effect on “all patients”. These were Dr. Linda Liau’s words and changing the endpoints around to still include PFS but diminish it’s importance as an early predictor, because of the original inadequate measuring techniques, now allows all patients to be compared to historically matched groups as well as groups within the trial itself. This broad spectrum of approaches allows for further validation of groups within the trial to possibly further confirm the use of historical controls in future trials. Dr. Linda Liau and NWBO are making the most of every day that goes into interpreting this trial’s outcome so that future trials can be done more ethically and efficiently and they have patiently waited out regulatory reform in order to do so while manufacturing techniques were being developed which will ensure a much more rapid ability to meet massive demand in nGBM, rGBM and off label without backlash on regulators or NWBO. Best wishes.
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