RE:RE:RE:RE:RE:ONC/Y and the FDAThanks to Quentin for this valuable comment. I agree entirely. I formerly had some professional interaction with a few FDA officials and I found them to be highly professional and motivated by serving public health while following the precedent in official process.
That said, I cannot understand why they do not more effectively embrace the concept of balancing risk and benefit that they were moving toward when I had a bit of involvement with them about a decade ago. They have to treat all applicants for licenses the same, in some sense, but many cancer treatments are dangerous poisons while pela gives you the flu. And it is efficacious in many contexts. But the statistical tests which use medians and not means, based on populations of patients near death, are hard to achieve to show benefit under those very stringent precedents.
If they balanced risk and benefit in more flexible ways, we would already be using pela in many contexts.