What matters is what the RA's think and how much they want to support the leading onco-neurosurgeons clinical progress. Despite a love of ridged formalism of some, as far as I know, nobody in the world except maybe for owners and promoters of Novacure are going to be in the least bit interested in throwing away this trial.
BTW anybody who cares about the science and clinical situation really ought to tune into to the Musella arranged Liau lecture which starts at 5:30 PM today (25 minutes from now).
Linda Liau is hardly a smooth talker but she is the preeminent GBM researcher in the US and probably in the world - few would dispute that. Linda famously said maybe 5 years ago, 'Everybody [all patients in this trial] is living longer.' It's well known that GBM tumors are by nature very mutating. Linda has explained that she came to discover that rGBM tumors are mutant and fairly uniform in being very different in genetic profile from the same patient's original GBM tumors. They came to understand in the clinic that results of treating rGBM cannot be directly compared to treating nGBM. This is fact, which you will know if you followed LL's lectures. That new clinical understanding is what is behind the clear-cut division between the rGBM patients and the nGBM patients (yes, in many cases the same patients had both diseases - yes, it's a mutating, complex, confusing as hell disease)
Some want to say that she can't learn that, as she did in the course of a 15-year trial and then use that knowledge to redefine the trial endpoints to conform with the newly discovered clinical understanding of this horrible and crazy disease. Implying that LL doesn't have a clue about how she can and can't conduct a clinical trial. Good luck with that assumption. We know a few clinicians oppose the trial, like all the Williams co-signers, none of whom are onco-neurosurgeons by the way - quite an important point, IMO.
I'm no expert on clinical trials, but I know that LL et. al. who wrote the SAP did not have access to the trial DB when they did so, because Linda and Ashkan and other investigators say so. Obviously, they knew about their own patients and could make inferences on a blinded basis (maybe they had clinical info that allowed them to make educated guesses concerning their own patients, but not anyone else's).
As a very important practical matter and a matter of life and death to GBM patients, per LL and the other investigators, dc-vaxl works. This fact is completely backed up by the subsequent research Linda and others have been doing for the last 5 years, testing other agents like CIs and they know without dc-vax to activate the T-cells, nothing works at all, but they do have good results treating GBM with combinations of dc-vax and the other agents.
We do not think that the RAs are going to throw away the ph 3 trial and force all the dying patients to wait until another 10-year trial can be completed to conform to the usual formal trial parameters before they can approve dc-vax which, BTW has been thoroughly proven to be harmless as well as efficacious. IMO that thinking is just way too rigid and unrealistic. Those who will decide this are not going to be financial speculators, they will be compassionate clinicians anxious to give hope and greater survival to GBM patients.
I'm sure according to the old school culture of the RAs vis-a-vis cancer treatments I might be dead wrong, but that ignores the true clinical value of dc-vax and IMO the will of the RAs to support the leading cancer brain surgeons' fight against GBM and very importantly, to give hope to GBM patients. JMHO.
