> You seem to think this is just a balancing of risks. No I don’t. I was saying that the kind of balancing you mention is out of scope for FDA to answer. The

> You seem to think this is just a balancing of risks. No I don’t. I was saying that the kind of balancing you mention is out of scope for FDA to answer. The fact you can’t find anyone to answer the question you want answered is not the FDA’s problem. I said go off-label if you want to (although off-label might be slightly the wrong word in this case). Good luck finding a politician that wants to tie themselves to recommending that, in case it turns out wrong.