Thanks @SPP1992 I have been following RAP's story for a number of years now since the earlier days of them listing at 2 cents. One thing I have noticed about this company during my time invested - they deliver their Australian results on time and if not there is an explanation stating where the study is currently sitting at with a new general timeframe of completion, usually not more than a couple of weeks. This sort of thing is normally announced as a "company update" ResApp aren't obligated to announce these updates but they do and have done so in the past if they hadn't delivered when they thought they would have. This sort of good practice that the company adheres to is very much appreciated by me.
Another thing I've noticed is that if they say the study results are due say at the end of the quarter they never come out earlier than anticipated it's always right at the end... The US double blind studies they had much less control over and couldn't deliver them to a schedule so they gave us an estimation as to when they believe these studies to be completed. Some of these timelines were missed especially for croup, but they did continue to update us. These third parties can sometimes take their sweet ass time to deliver the goods, they may have more pressing issues to deal with at the time or technical issues causing delays who knows...
So here we are with imminent news due CE mark approval is something that is out of the company's hands but is anticipated any day. BSI gave ResApp an estimation for Fast Track approval for a class 2A medical device to be in the order of 3 to 5 months. We're now sitting at 6 months, delayed - yes but it's out of ResApp's hands. Since they keep using words like expect CE certification decision "very very shortly" or "imminently" and the fact that they have been in close communication with BSI suggests to me that this wording has come from BSI during the back and forth communication with the company.
OSA - Well yes there is a third party involved here as we are conducting a double-blind study, however ResApp would be in close communication in relation to how things are progressing and if there were any delays I'm sure they would know about it. Considering Friday was the last trading day before the end of the quarter and we had no usual update from the company to me suggests results will be out over the weekend with announcement on Monday. If all goes well and we receive positive results similar to those double blind results produced late last year (80% region) then we could have an explosive open.... The thing I like about sleep apnoea is that the company will be targeting the market as a screening tool, with potential diagnostic capabilities (seperate submission) depending on the level of accuracy. CE clearance for a screening tool using a mobile phone is extremely low risk, therefore CE Mark can be granted Within 4 to 8 weeks after submission for a class 1 low risk. The uptake of this could be massive considering the amount of people who have sleep apnoea or who will develop it at some point in time. It is estimated that 80% of people who have sleep apnea don't even know they have it and "1 in 4 Australian adults are at risk of developing sleep apnoea"
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