The notion that a personalized DCVax-L or even the new personalized Car-T shots are not exactly what is described there, just more sophisticated version than they understood originally. But it still directly fits there and is exactly what they had in mind, but technology is moving faster than the minds of our very slow regulators when they write such GUIDANCE years before such treatments seem possible. DCVax-L is personalized and is MORE agnostic than the agnostic maginot line nonsense that you wish to limit them to. It is more targeted than pharmaceuticals or biologics that go for only one point of vulnerability. It is dynamic in the discovery of specific oncology targets for a given cancer AND the person’s specific cancer. It can do both. They’ve already identified the antigens it can and does pick-up, and some were known causes of GBM, some were not and some will no doubt be in other cancers as well, which is a whole other point of proof for them to pursue. Nothing there excludes such drugs as DCVax-L personalized or Car-T, personalized. And while DCVax picks up a broader array of antigens by the use of the cell that is purposed in the body to do so, instead of a computer doing it, the processes are very similar.
Molecular alterations are EXACTLY what DCVax-L targets across any and all cancers. It can target the same or more. Your logic of exclusions of better, and gross over-simplification, are a constant point of contention. It suits your investment position to make these small bore, points to disinformation and misinform anyone who might come here to learn more.
Immunotherapies are exactly what that GUIDANANCE was created for, amongst other things, but guidance is not a regulation and it is not the law also, the regulator can make sense of anything that would be nonsensical on its face and your argument is nonsensical, on its face.
Now I am not arguing they will have that from day one, only that it clearly will be the appropriate direction for this treatment and this kind of treatment to go. And doctors, I have no doubt, will see it immediately as such. It’s a personalized cancer vaccine, period.