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Ann: ResApp Completes Successful Pre-Submission Meeting with FDA, page-50

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #

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Philanthropist

84 Posts.

17/03/16

13:42

Post #: 17300110
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Originally posted by rnclarke76 ↑

Hi Pierre83 - Dr Tony mentioned yesterday ResApp is at least 4-5 years ahead of any competitor in this space, multiple patents have been submitted which basically convert sound recognition into a result - I would not be concerned at all about competitors.

The FDA meeting clarified ResApp are on the right path and tips were given making sure we clear all necessary hurdles. ResApp are not applying for a complex FDA approval, the FDA approval will not give RAP the license to launch this on the app store or be used solely by a consumer - Its intended for tele-health markets. A Dr or Nurse is still in the loop in the telehealth model and ResApp is an acting as an aid to diagnosis, the regulatory requirements are not as strict and since diagnosis will still be under the surveillance of a doctor it is much less of a hurdle, remember this is a Class 2 medical device not a heart transplant. Plus we have Experien Group with 99% clearance rating walking us through the process.

Multiple US sites may be coming live very soon, I believe we already have enough patients (the number was 400 for the pediatric study) but because it is a machine learning algorithm they are continuing to enrol patients which will only increase accuracy (see last slide of investor presentation). US trials are only a formality and a requirement of the FDA.

Adult study results are enrolled with good numbers, there is no early indication on accuracy numbers but I am very confident the numbers will be fantastic. The algorithm is basing its conclusion of the disease on data from others so the more patients the higher the accuracy.

All this short term stock movements is great entertainment. Its like watching the grand final of your favourite team playing and already knowing the score at the end.

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I havent heard of any competition to date. However it is only reasonable to wonder if our sensational new product will sooner or later attract competition. And how effective will the patents be? But even if another team were to develop a similar app, it would take clinical trials on thousands of patients over several years.
ResApp is here, now. It wont be long before it's commercialised, out there in the market, and even better than it is at present. A formidable advantage.

RAP Price at posting: 24.3¢ Sentiment: Buy Disclosure: Held
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