You’ve got it backwards. NWBO is not “excluding” anyone from the trial, the indication for which a license applies has been redefined. They luckily have an inclusive trial that covers both GBM and Glioma. NWBO never defined Glioblastoma and would not be doing so now. A license is for Glioblastoma as defined by the FDA.
You’ve got it completely backwards and are suggesting NWBO is doing something wrong by being prepared to answer the questions that the regulator will necessarily need to ask.
That it happens to show more efficacy is merely an ancillary benefit. You seem to keep implying, even after you contradictorily say it is the WHO, that NWBO is driving that conversation. That is false. It is the scientific community and ultimately the FDA that will be driving the licensing process for a drug for “Glioblastoma”, as defined by the medical community, not NWBO. The regulator will drive that conversation, and they will see apparently a mechanism that is confirmed. DC’s identify mutations and antigens, the mire mutations and antigens, the more effective the immune response. it makes scientific, practical and theoretical sense. It seems to be upsetting people that by accident it actually HELPS the trial by showing more efficacy.
It’s not like the FDA will then bend the new definition to fit the drug. Nor is it likely that they will ignore the results of the trial. I know many people in all sides of debates related to drug licensing like to villainize the FDA and regulators, but that is simply not how these things work.
And trying to flip it around like the company is driving this redefinition to benefit itself is clearly, flatly incorrect. The FDA will be driving that analysis.
It’s not a crutch. The science has been updated by the broader community and regulatory agencies and it just happens to favor this trial. It could just as easily have gone a different direction. It didn’t. Has nothing to do with anything NWBO is doing to create any “benefit”. It’s nonsense to see it that way. It has nothing to do with them, it just happens to make them look better because the science going on elsewhere confirms the science that this trial is based upon. It’s the best of all possible worlds.
It’s CONFIRMATION by the larger world, of the science in this treatment, not a change of anything by NWBO. The larger world, by other means has defined GBM a certain way, and it confirms the mechanism that was predicted by this trial. Period. And the regulator will be the one driving the analysis. It’s why they reserve the right to scrutinize SAP’s. If it had gone the other way, then NWBO would be looking at a treatment primarily for gliomas. Either way it would be useful, but a license for a particular indication must be driven by the definition of that indication. Anything else makes no sense.
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