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To make the case that something is better than nothing is not the law of the land in United States. That's not the evidentiary basis for market access. They have to show substantial evidence of efficacy, and they didn't, you can argue that, theoretically, that this drug should work, but we don't approve drugs on that basis in United States. We do it based on data, not based on theory.

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    In which movie does this quote appear: "Houston, we have a problem"?
    A 2001: A Space Odyssey
    B Apollo 13
    C Conquest of Space
    D Star Trek Generations