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Everyone posting here confidently saying that the FDA is clearly wrong is pretty disappointing to me.

I think of all the comments about how "MBAs" and "marketing people" just don't get software development. And then I look at software development people who seem to think they clearly get medical research and regulation.

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The problem is with how they are handling their data. You don’t have to know anything about biology per se to see the issue. It is entirely mathematical. By the way, the medical establishment has a terrible track record surround use of and understanding of statistics. I don’t think it’s right to suggest that self described experts are somehow infallible.

I'll take self-described experts who work at the FDA over self-described experts on a social media site like HN.

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