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22:32
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Originally posted by Red bar:
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Remember our USA consultants Experian group have a 99% clearance rate from well over a thousand submissions that they handled for their clients. Do you think they would have taken on the case if they didn't feel confident of a successful outcome?! Obviously they believe it has a good chance of obtaining FDA clearance. Even Morgan's stated in their last brokerage report that they are confident that RAP should get FDA cleared. You don't need staggering results to obtain FDA clearance. Of course the Australian results would look better but at the end of the day doctors with a stethoscope are less than 70% accurate in providing an accurate diagnosis. Even with all of the other tests they still couldn't agree. For our algorithm to have been above this 70% endpoint is a very good outcome considering 30% of the time they required a third adjudicator for the final say. The FDA has been in contact with our CEO Dr Tony Keating and he has been replying to all of their questions. If there was anything he could not answer this is when we have issues.. nothing has been publicly announced suggesting bad news ( they would have had to announce it if they could not answer any of the questions) so our company must be highly confident and we should get a positive outcome shortly.
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Yes I agree, the fact that in ~30% of cases they needed a third opinion highlights the industry is in need of a more effective method. It just depends if RAP can be that. IMO I feel it will be, eventually.
