Dear fellow RAPpers
Firstly I would like to apologise in relation to my absence in posting. Arrived home quite late after the meeting and was planning to post the following day but my daughter was quite sick so my priorities were with the family rather than this forum.
I've had a quick squiz at some of the posts and there have been some beauties since... I'll probably windup repeating most of what was said over the course of the past couple of days but here goes anyway...
The meeting commenced a little late 10:05, Chris Ntoumenopoulos ( that's a mouthful hope I spelt that correctly) was holding up proceedings and had to be contacted via phone conversation in order to proceed. The auditor was also on the phone.. I was the first to attend the meeting and arrived at same time Tony Keating did just after 9 a.m.
It was great catching up with a few familiar faces and meeting a few other fellow shareholders. Nice to see you there
@mumstheword@Dhm@RudeeOne@White Horse@gothechooks etc.
Funny story
@mumstheword regarding being pulled over by the cops realiting to your RESAPP number plate and then asking if he was a shareholder OMG I cracked up
lol I thought a bidding war was going to start for your plates there for a moment but the starting price was a bit too high for a spec stock your plates could be worth a lot though if she becomes a blue chip 1-day
...
One of my very first questions when I entered the Dragons Den/ Shark Tank ( lol reminded me of this for some reason
) was about US safety conformity compliance. I was curious to find out whether we required to obtain something similar to ISO before being granted de Novo. The answer was that it's voluntary and you basically just say that your product is compliant intreasting read here:
https://www.fda.gov/medical-devices...andards-and-conformity-assessment-program#howAlso Tony mentioned to me that a lot of companies are going to be finding it very difficult over the coming months as regulatory changes approach. Many Class 1 will become class 2 a lot of Class 1 may not comply with the new changes and could be in trouble.
Very good to hear that our company is very much ahead of the curve relating to these changes...
"The FDA is presently working on the proposed rule, which will be issued by 2019, that can make the transition to ISO 13485 possible in the US for regulatory purposes. The rule is titled
"
Harmonizing and Modernizing Regulation of Medical Device Quality Systems".
https://www.google.com/amp/s/blog.s...-fda-cfr-part-820-medical-devices?hs_amp=true"Three regulatory changes affecting medical device organizations todayRequirements for three foundational medical technology industry programs are in flux and are expected to impact your company over the next three years. These include:
- Medical Device Single Audit Program (MDSAP), adopted by regulators in the US, Canada, Japan, Brazil, and Australia
- ISO 13485:2016
- EU Medical Device Regulations (MDR)"
https://www2.deloitte.com/us/en/pag...echnology-regulation-change-implications.htmlAs you can see there is a lot happening in this space.
Interestingly one of Chris Ntoumenopoulos companies just recently received 510k clearance after lodging in April. De novo applications are much more complex as they set a precedent for other similar medical devices that come to market like RAP's, so it ultimately will take a little bit longer. According to Tony Keating we are getting very close to an answer he said we are not at the beginning and we are not in the middle but we are now towards the the end for a decision and the communications between RAP and FDA have been very positive and are moving towards the end of discussions.
The German hospital is moving forward, Clinical Research ethics is being finalized with the partner and is looking at commencing the pilot this winter.
Our company only intendes to partner with blue chips and not every Tom Dick and Harry.
A new marketing video was released at the AGM targeting European clients it was very entertaining it even received a few giggles from the audience
Our company has enough runway in terms of money in the bank for the time being no CR is required at this stage. I'm hoping one is not necessary as deals role closer to finalization.
A little bit more was elaborated on regarding DRAPA they are looking to evaluate their health passively by monitoring their Personnel measuring lung health, it is audio based 24/7 monitoring of people's health is there end game..
Medical San Frontiers - this has not been a priority and the team has defocused from the developing world over the past 2 years but over the past few months they have stepped up their focus in this area again. ( probably they received interest after CE clearance came through IMO)
Currently in Advanced discussions with potential European deals.
Things going really well with Sanofi they have a Global footprint and are looking at the consumer side of things China is another area that Sanofi could enter with us RAP have also been approached by potential partners in CHINA.
We have a small team of around 16 staff at present and this is one of the reasons our company will look to partner with blue chip companies in order to increase production on a global scale at a much faster rate.
TGA for adults is a certainty as far as I'm concerned and is only being held back by red tape due to the company recently changing address. The notified body is taking much longer than anticipated just to update this. CRAZY as far as I'm concerned it's a 1 second job
lol
Tony mentioned towards the end after receiving a question by one of the shareholders that Generation 2 is set to be very exciting with a new line of improvements and products coming forth
I know that the breathe easy study is continuing so new development is probably coming out of that ongoing study.
Sleep apnea was also discussed the mention of DROWZLE was brought up and the points that I have highlighted in my previous posts. Our company is very encouraged with their 510 k clearance in particular the fact that they had to incorporate questionnaires Within there app. We have not Incorporated these question as yet we have achieved higher positive and negative percent agreements. In my opinion there is a very high likelihood that we will receive FDA clearance with results as they stand today. Check out my previous post as I have discussed this in detail) study was double-blind and conducted under the American Academy of sleep. We will first Lodge for CE clearance, than TGA. ResApp is still looking into whether or not we can lodge to the FDA based on our current results... DROWZLE has marketed their product as more of a wellness package where as we will be marketing our product as more of a medical screening tool, most probably a class 2 device through medical professionals.
In summary it was a great meeting. I'm in courage to invest further into our company after this wonderful meeting. The resolutions were all passed but there were a lot of NO votes particularly for the options which have an exercise price of around $0.41, I questioned the issue of these options to the non-executive Directors they argued the point with quite a good come back... I'm sure the issue with these options is going to be forgotten about quite quickly on the back of FDA clearance as I can see our share price hitting all-time highs if this is announced as a positive outcome. Thinking we will get there within the next few weeks as the discussions draw near to a close with positive communications and Experian groups backing with a 99% clearance rate we look like we are in a very good position...
PS a good question from one of the shareholders was put forward to the board about having more skin in the game, well it is very likely that Tony will exercise his 20 million or so options as he has an average exercise price of around $0.07. So he will have plenty of skin in the game shortly. That money (around 1.4 mil) will go into our company's bank account. After the grilling the other directors confessed that is a good idea and that they will be looking into it.
Again apologies for the delay in posting this. Thank you all for your concern and thanks for reading.
Cheers
Red bar
