RAP (ASX) Ann: ResApp Submits De Novo Application to the FDA

Originally posted by Red bar ↑

Yes @silverfox3731 I remember that meeting went extremely well. Tony was advised that there were three representatives going to be present but when he arrived to his amazement there were actually 11 reps. TK presented all of the information on hand from previous studies and after going through all of the detail the company was given fantastic feedback in order to prepare a detailed submission to their specifications. This information was gold!! De novo = revolutionary device, safe and effective tool in the eyes of the FDA. ResApp has applied for a de Novo class two medical device as requested.

Key requirements specified by the panel stated that we must complete a double-blind US study, it must be sadistically significant and it must be at least as good as the accuracy is today as a doctor with stethoscope. Now there are no set guidelines as to how accurate the doctor is with a stethoscope but there are many medical journal research papers that show accuracy as low as in the mid 60% region and as high as 75% accuracy. One can take a step further and argue the fact that the accuracy through a telehealth consultation is more than likely much worse than the accuracy with a doctors stethoscope today because one can not actually reach out through a monitor with a stethoscope they're pretty much just guessing based on visual features and explanations of their symptoms from their patients online. Red or black? IMO Doctors during a telehealth consultation at present are just gambling with people's health when it comes to determining their respiratory symptoms. The amount of unnecessary antibiotics being fed into people's mouth with the body building a resistance and the bugs becoming immune to the very thing that is supposed to destroy the bug in the first place is very common today unfortunately...

What we have truly is revolutionary and I would be extremely surprised if we were not granted FDA clarence in the coming months, we are as good as a doctor with a stethoscope for the three respiratory diseases lodged...

Cheers

Red bar

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Lets try and extend this discussion a bit Redbar from a couple of points you have made.

The FDA panel told RAP it wanted to see a US double blind clinical trial that produced statistically significant results.

For the benefit of the forum would you like to offer an opinion about:

Why did the FDA panel want to see statistically significant results?

What statistically significant results (if any) were produced from the US trial?

Have a crack if it takes your fancy and we can see where the discussion heads.