@SwingTrade : "when a double blind independent study was conducted the results weren't even close to the in house results" – I'm going to assume this is a genuine mistake rather than a deliberate misrepresentation of the facts...
TLDR:
- timelines pushed out: yes, some
- multiple raises undertaken: yes, four. IPO to purchase IP in 2015, raised $12.5M in 2016, $7.5M in 2018, $5M in 2020.
- approvals pushed out: only FDA. Everything else – CE Mark, TGA, India, Indonesia, other countries – pretty much to plan.
- Early days RAP claimed these amazing results: pure bunkum. RAP produced actual amazing results published in medical journals.
- share price collapsed and never really recovered: half bunkum. Share price did collapse but recovered as regulatory approvals and commercial partnerships were achieved. The drop to current levels really only began in 2020 with the pandemic diverting medical development to the pandemic.
More detail:
Firstly... those "in house" results weren't in-house. They were properly conducted clinical trials by Curtin University at their Joondalup Health Campus. Here is an announcement from 22 June, 2017:
https://www.resapphealth.com.au/wp-content/uploads/2017/06/1684564.pdf
There were several studies conducted in Australia. All returned extremely high levels of agreement.
Secondly... there were
two sets of appalling results, both from clinical trials conducted in the USA. Both disappointments resulted from the conduct of the trials rather than the diagnostic capabilities of ResappDx. The first trial failed
spectacularly, primarily because of an appalling lack of preparation for both research staff and the regular clinical staff:
- No efforts were made to control the environment in which the cough sounds were recorded. While the app is capable of filtering out quite high levels of background sound including loud conversation, the noise levels in the clinic were extreme: televisions playing children's programs at high volume, nebuliser pumps running next to the phone, other patients coughing, staff and patients calling out. The app has since been modified to alert the user if the noise levels are too high to allow accurate cough analysis.
- Patients presenting with suspected asthma were given alleviating treatment before diagnosis with ResappDx, resulting in a complete washout for asthma as an end point.
The announcement of the first USA trial result is here:
https://www.resapphealth.com.au/wp-content/uploads/2017/08/1699466.pdf
The second trial failed, not quite so badly this time, but still well below the levels measured in Australia. The key factor behind this (discounting unprovable conspiracy theories about interference from other pharmaceutical companies) would have killed the first trial even if data collection had been properly controlled, and would still kill a trial today if the company were so foolish as to try again. It comes down to the quality of adjudication available for the target conditions in US paediatric respiratory clinics. Because there is no national health system, and both patients and insurance companies are keen to minimise their costs, testing and treatment is conducted for speed and cost-effectiveness:
- If a patient presents with suspected asthma the clinic will administer ventolin. If the patient gets better, it was asthma. Test and treatment combined.
- If a patient presents with suspected pneumonia the clinic will take an X-ray to eliminate other obvious possible causes and send the patient home with antibiotics. If the patient comes back worse four days later, it wasn't pneumonia. The result is that the accuracy of the adjudication for pneumonia was only about 70%. This is already below the Australian agreement rate for ResappDx. So basically pneumonia is completely out of reach in the USA as an end point without a university-based research project that would cost more millions that ResApp has.
The announcement of the second USA trial result is here:
https://www.resapphealth.com.au/wp-content/uploads/2018/10/1863471.pdf
The high quality
Australian study results have since been accepted by regulatory authorities in huge markets across all of Europe, Indonesia, India, and Australia.
