LDX lumos diagnostics holdings limited
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Ann: FDA Decision for FebriDx, page-9

  1. linear
    1,524 Posts.
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    11/07/22
    10:27
    Post #: 62471258
    I don't really understand this. So, was the issue of false negatives THE reason for non-acceptance by the FDA?

    If so, how is it any different to the risk of false negatives with any other diagnostic test? I understood the predictive accuracy of the test was ~ 99%?

    Or is there more to it, and other problems were found in the 'evaluation of data for FebriDx' by the FDA?

    LDX Price at posting: 6.2¢ Sentiment: None Disclosure: Not Held
    Likes Created with Sketch. 1  Upvote
    lightbulb Created with Sketch.  Great analysis
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