As to medical regulation and many, many other problems, you would think we all could agree on many points and if we could get politicians to put practical solutions to problems first and collaborate instead of the “if they’re afore it, then I’m agin it!” silliness, we could make so much progress. But lots of outside forces are finding the gaming of our multilayered system of governance. They understand the rules and how that works better than ordinary people.
So the regulations that cover drugs like DCVaxL will and do evolve much slower that would be optimal, and often not far enough.
But I think we are slowly making progress, and we should see some good initiatives out of the FDA which I believe will speed DCVax related treatments to patients in the future, once the new rules and guidance documents go into effect. I think we will see more access pre-approval, and open trials with external placebos for already approved products.
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