Sorry, Cog, I have to point out that these things are supposed to be established before approval!!
And you could say I have an agenda about the ICI's and their dangers. And you'd be right! I think the associated dangers are being underplayed, hidden, or denied (like the FDA did in the quote I gave!)
And as regards NWBO, I am wary about DCVax combos with an ICI. Many of the recent lung cancer trials are demonstrating increased toxicity, when two ICI's are combo'd, or when a chemo is combo'd with an ICI, such that (at least in my humble opinion) the toxicity risk outweighs any benefit that might accrue to a minority of patients.
The fact that DCVax amazingly has proved thus far to be entirely benign in respect of side-effects is something worth hanging on to.