One question I have is what happen with patience non-compliance? The pill is supposed to be taken over five days, every 12 hours at home (I think 40 pills total). There's going to be a lot of incomplete regimens in this scenario. How does this affect this risk?
Haha! The part here (from page 32 on) doesn't end with a conclusion. It just says uncertain! (There must be some monitoring mechanism for ongoing use, right?) https://www.fda.gov/media/154418/download …
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I mean, that conclusion sounds right to me. I'm not an expert in this subsubfield, but I know some folks who come close, and as far as I can see it's unknowable. And as you said, it's societal costs at play here, not individual - not sure we have a regulatory framework for that.
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I don't say "unknowable" nihilistically - I think it's worth thinking really hard about and modeling and etc - I just think there's likely to be a limit to the certainty one can achieve on the question. And I don't know who even asks the questions. Right… back to grant writing.
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