Evening all!
As most of you are aware I attended the TechKnow investment Roadshow today and bumped into a few familiar faces. It was great to group together and brainstorm the latest announcement today.
Tony presented well and was calm cool and Collective. Brian was much the same. Chris Ntoumenopoulos was also present. Good feedback from the guys...
The major take home for me was that the results presented today are good enough to still proceed through to the FDA for upper respiratory tract infection lower respiratory tract infection and asthma. These three will generate the largest revenue stream for ResApp and are the main ones that the telehealth companies are looking for diagnosing their patients through this particular setting as there is obviously no way a doctor can reach out through the monitor with a stethoscope, especially when it comes distinguishing between upper and lower respiratory tract infection. this will be the main market for us and it is what telehealth companies want NOW!
TK also informed us that Croup results are likely to be positive enough to lodge for a submission. Quite a bit of work still needs to be done to work this respiratory ailment out expect an announcement on this within the next couple of weeks..
Our company is fully funded all the way through to commercialisation. What a great move it was raising capital at $0.22 per share! Especially after today's overreaction in the selling. mostly retailers would have been exiting today in my opinion and considering the news the volume was quite light... Especially when one compares this to the volume we witnessed during the SmartCoughC1 sell down last year. I think a lot of retailers would have been holding out to sell on this news hoping for some quick profits. This should bounce up from here, what an overreaction today!!!
I think
@RNClarke already explained the discrepancies between the Australian results and US results perfectly...
Talks are ongoing with various telehealth companies. It was mentioned that some are only interested in distinguishing between upper and lower respiratory tract infections.
There is a very strong case for obtaining approvals from the FDA for the three successful test results. Submissions for the US Europe and Australia will take place this quarter.
TK does not believe that the WASH and the LOI with the German hospital will be lost because of these US results. The German hospital is conducting their own in house study and will start during their winter. Tony Keating mentioned that he will be flying over to Germany next week and that he will be given an exclusive walk around and shown in detail the procedures and processes that take place over there. With TK gathering this information it gives us the upper hand to produce amazing results within that region...
Very little details or comments were made on the WASH program however it was mentioned that something different is being tested with in this area, whatever that means? hmmmm.
They're also talks of other potential uses that ResApp could venture into other than just using sound alone to make a diagnosis or a screening tool for OSA. The camera on the phone was also mentioned as one possibility that the company could venture into.. hmmmm perhaps facial recognition + sound combination...
It was also mentioned that because there is no set percentage point for accuracy levels between diagnosis of certain respiratory conditions ( 75% was the benchmark set for pneumonia by the company) it looks like they have a good case to present to the FDA to obtain approvals for pneumonia etc ( respiratory conditions below 70%) without the need for additional studies. This will not be happening however until clearances are obtained for the 3 respiratory diseases already with good enough results to see us through to clearance. If the FDA requires further studies for these lower percentage respiratory disease outcomes then this is what they are referring to as "phase two". in saying that the company will now pursue commercialisation and this will be the main focus.
Experian group, our consultants in the United States have a 99% track record of being granted FDA approvals. We have obtained good results for upper and lower respiratory tract infection and asthma. This will be approved by the FDA I have only a one percent doubt that it won't be
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Picture this, if we were just an asthma company hoping to get our revolutionary tool to market and produced results that we did today knowing that they are good enough to be passed for clearance by the FDA what do you think the share price would have done today? I very much so doubt it would have dropped by over 50%.
I would assume it would do the opposite and go up 50%. We will be applying for 3 FDA clearance at once and another 6 throughout Europe and Australia. That's HUGE in my book. I can't think of one company out there that will submit 15 submissions for clearance in total at once! Can anybody else? By the way that is excluding obstructive sleep apnea! Which is another massive market in its own right!
LOL speaking of obstructive sleep apnea Brian was sharing a really sexy photo of himself throughout the day
he was all wired up and partaking in the latest OSA study where by the participant must take home a home sleep test along with the smartphone to be tested. this study is being ramped up and is expected to be completed this quarter.
interestingly there have been some major developments within this area and I will post a link now to explain what I'm talking about...
https://www1.racgp.org.au/newsGP/Professional/Changes-to-the-Medicare-Benefits-Schedule-What-GPs
now if you read this article above you will understand what is happening here..
As of the first of November this year Medicare will no longer be reimbursing patience who go into a sleep clinic or take home a HST without sufficient evidence that they actually have a good chance of this:
"GPreferrals for respiratory function and sleep studies
Diagnostic services for sleep disorders
GPs will be able to directly refer eligible patients for diagnostic home-based (unattended) or laboratory-based sleep studies for obstructive sleep apnoea only when an approved assessment tool has been used. Further investigation of suspected sleep disorders can be ordered by referring eligible patients to qualified adult sleep-medicine practitioners and consultant respiratory physicians.
In order to directly refer patients for a diagnostic home or laboratory-based sleep study to confirm a diagnosis of sleep apnoea, GPs will need to use approved assessment tools, which include either one of the below:
- STOP-BANG score ≥4
- OSA50 score ≥5
- Berlin Questionnaire – high risk
Plus an Epworth Sleepiness Scale score ≥8."
RAP will have a revolutionary screening tool, it will be quick and easy to use, in fact you can do this in your sleep literally
lol! who has the time of day to fill out all this crap? I know for sure that I want less paperwork in my life thank you very much!
- STOP-BANG score ≥4
- OSA50 score ≥5
- Berlin Questionnaire – high risk
Plus an Epworth Sleepiness Scale score ≥8.
If this information is not provided then GP referrals will no longer be accepted for reimbursement, so ultimately the patient will be out of pocket by hundreds of thousands of dollars...
ResApp is developing a screening tool. As a male you have a 33% chance of having sleep apnea and 80% of people who have sleep apnea don't even realise they have it. What perfect timing this is for us!! So far results in this field have been outstanding. chances for obtaining FDA clearance on this one will be very high too especially knowing that we've already tested this in sleep clinic... if this is passed by the FDA then people could have ResApps option instead of all of the above crap.
All in all it was well worth the journey to the conference today. Obviously would have been more exciting if results were all approvable across the board but that's life, there you go...
Hopefully this information helps you all a little...
Cheers
Red bar
