Firstly - well done ResApp - as an original holder from the IPO - I am relieved to see we are another stop closer to commercialization now ...
From TT this morning - need to correct some misinformation here: "The difference between the US trial and the trials we do in Australia is here: "Performance of ResApp’s algorithms was evaluated ... compared to a clinical diagnosis reached by expert clinicians with full examination and results of investigations(including, where applicable, microbiology, chest x-ray, CT, spirometry and bronchodilator testing)" (announcement 2019-04-23: Positive Results from Australian Adult Clinical Study) In the US emergency departments (where our trials were conducted) don't do anything approaching a "full examination and investigation". They do enough to identify the most probably cause, start treatment, and shove you out the door with a pat on the fanny and a "come back in 48 hours if you're not improving". Therefore in most cases our adjudicators have clinical notes and maybe a chest X-ray if the ED ordered one. We don't get recalls, follow-ups, or extra investigation. The only way we're likely to get better agreement in a US trial is in a university hospital where somebody is prepared to pony up the cash for the extra investigations required for higher quality adjudication."
The US study was conducted in 3 major US University affiliated teaching hospitals. The results are analysed on patients admitted to hospital just like they were here in Australia. The big differences are that in US they do lots more X-rays / scans to try and prove the diagnosis and there was greater disagreement amongst the "experts". These expert adjudicators are experienced respiratory physicians - the problem is that in Medicine many things are not black and white. Expert radiologists ( the doctors that just spend all day looking at X-rays and reporting on them) can only agree about 70% of the time. When you combine that with interpretation of other tests, different doctors interpretations of physical chest signs - the experts couldn't agree on the diagnosis in about 60% of cases. Adults will be easier - but the US adult trial will need to be tightened up further than the last kids one if ResApp is to get full approval in the US. IMO you shouldn't have to do another trial in the US when the agreement amongst doctors is so poor. Perhaps a pre-trial just looking at percent agreement of 100 adult cases should be conducted first to see where problems in adjudication may lie, before you add in smart phone comparison?
The good news is that once CE mark for kids is approved , the adult CE mark will be just a tick the box scenario and commercialization globally can begin....
RAP Price at posting:
16.5¢ Sentiment: Buy Disclosure: Held
