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18/04/16
13:00
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Originally posted by ScrimpyCat
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One way I'm aware of is applying for accelerated approval under certain circumstances, as well as being categorised as a fast track product.
Now what might RAP be doing to get it accelerated I'm not too sure. Maybe they're just going to apply for it and increase the rate of clinical trials? Not sure if that will qualify for an accelerated approval however. Another thought that occurred to me, was maybe being able to diagnose particular diseases might make the FDA speed up the approval process? For instance we know management has been thinking the tech could possibly be used to identify lung cancer, so maybe that's something the FDA will value as being of more importance (honestly have no idea though, couldn't find anything under the relevant sections in the FD&C Act to hint towards this). But I feel like if that was the case we'd know a lot more about the tech's prospects with diagnosing cancer.
An entirely separate thought I had was maybe it could be some partnership deal but I'm not aware of how that could speed up the process. But maybe there is some extra preference given to larger institutions?
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Thanks Scrimpy Cat I suppose another way of looking at it is if there are multiple clinical trials at Top end Hospitals in the states, these equates to a greater data base and if the trial results are roughly the same, the FDA may expedite approval without requesting further validation.
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