COVID-19 Instant Screening test, page-343

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AlCp

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31/12/21

13:43

Post #: 58586480
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Originally posted by TerribleTadpole ↑

I think you need to post on Hotcopper a little earlier in the evening, when you have more time to explain what you're thinking. Or leave it until the morning when your mind is perhaps a little clearer. Because this post is completely mystifying.

The FDA decision was justified by the relatively low agreement rates obtained in Smartcough-2. Resapp is trying to have ResappDx approved as a definitive diagnostic tool, which would determine the treatment regime chosen by a medical practitioner. The benefit is that the test is fast and inexpensive. The risks are that a condition will go untreated, or that the wrong treatment will be prescribed for a misdiagnosed condition, or that a healthy person will undergo unnecessary treatment.

Is hauling the FDA in something US Senate does? What would it achieve? The application, the data, and the reasoning behind the decision are all available to the Senate if it's interested.

What difference has "whats happened with Covid" made to the diagnosis of ResappDx's target conditions? Is pneumonia more urgent or dangerous now? Or bronchiolitis? Or asthma?

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The decline wasn't based on efficacy otherwise this would have been decline early in the review instead of them requesting further human factor studies 8 months into the review.....I guess the US isn't as further advanced in using the smart phone as a medical device as initially thought.
RAP Price at posting: 6.2¢ Sentiment: Buy Disclosure: Held
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