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pembo111

2,193 Posts.

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22/10/15

17:22

Post #: 16232753
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Originally posted by Lefevre ↑

Yes, a great event today.

Red bar and I caught up with Tony Keating and Brian Leedman before lunch and after the preso.

I will outline a few comments below and Red bar I am sure will add to them later this evening.

The pre FDA meeting in the next month or so is a massive event and the FDA will outline exactly what is required for FDA approval. Their USA advisors already have a good feel and reckon that RAP are already well on the way to meet the anticipated guidelines. The first FDA approval will be for asthma and pneumonia. The testing results so far only support asthma and pneumonia. They have had results for other respiratory diseases but they haven't been large enough samples. Then within 90 days of that approval they can apply for bronchitis, hooping cough etc when they have had big enough samples which is less than 50. The FDA approval for the extra diseases will just be a formality.

Their FDA application is for a Class 2 medical device. They have to show safety and efficacy. There is obviously no safety issues ( its just a cough into a microphone). They only have to prove efficacy and it is felt anything above 90% is more than satisfactory. A GP is only 70 to 80% accurate and a specialist is 90% accurate. We are currently 97% accurate.

RAP has already had many approaches for licencing and partnerships but have them all on hold until after the pre FDA meeting as they want to maximise RAPs bargaining position. So, by the first quarter next year we should have some commercial deals outlined. The main target market is the Tele health providers in the US and they are talking about $5 to $10 per use. That is massive when 30% of all tele health visits are respiratory.

I get the impression that a WHO deal could be at anytime. The revenue model for WHO will be much cheaper and will be more a subscription model as they could possibly test thousands of people in a day.

The trial in Indonesia was with a Samsung and the trials in Australia are with an i phone. Tony feels the microphone from different phones is not an issue as they are all of excellent quality. The FDA approval will be for a microphone of a certain minimum bandwith which all phones will have. Interestingly the trials were all done in the emergency departments of the hospitals where outside noise is a big factor. The algorithim was not affected by any outside noise.

Keating and Leedman were not available at the booth for questions for most of the day as they were at meetings with fund managers. All the other booths were stocked and RAP's was empty.

It was a great day. Well worth attending.

Look forward to Red bar's comments later.

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Great insight mate, much appreciated.

RAP Price at posting: 4.5¢ Sentiment: Buy Disclosure: Held
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