Dewophile, first I want to say your contributions are fantastically helpful here. And that's not a prelude to a dig, but a long overdue thank you.
I have less insight than you into how tricky it would be for the FDA experts to figure this stuff out in advance. I'm not a knee-jerk anti-govt type, but watching the FDA biostats guys at the Provenge AC - they were even more incompetent than DNDN's presenters (!) - and reading the science board's critique of the FDA and so on, I think JP may have it right.
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