One thing you guys should understand before you bet the house on this thing is that contrary to what is being claimed on HC Tali train does not have FDA regulatory approval as a treatment for ADHD. Or as a treatment for ASD or in fact as a treatment for any condition.
The FDA classification for Talia train is as a “computerised cognitive assessment aid – exempt”. It was exempt from the 510(k) pathway because it is specifically not to be used for the diagnostic assessment of any specific disease or condition.
Hopefully everyone can read … and recognise that assessment is not treatment.
So how did Tali train get this listing (not “approval” or “clearance” for assessment and not for treatment?
Well because Tali train comprises both assessment and treatment (training) components. The listing relates to the assessment component. But note not only does the listing have nothing to do with treatment of ADHD. The cognitive assessment itself can’t even be used as an aid for the diagnosis of ADHD. If this claim had been sought Tali train would not have been exempt from a full 510(k) evaluation.
Why hasn’t Tali train applied for approval for the treatment of ADHD?
Well for the simple reason that no trials of Tali train have ever been performed in children with ADHD.
The two RCTs conducted with Tali train were with children with intellectual and developmental disabilities. In order to get FDA approval for a treatment you have to run trials with people who actually have the disease or condition you are claiming to have an effective treatment for.
This is why Akili (the example used by 8horse) have conducted a trial for their ADHD app in children that have been diagnosed with ADHD.
Akili has filed for 510(k) clearance for its ADHD app following positive results from a P3 trial in 380 children diagnosed with ADHD. Children on medication were required to undergo a wash-out period before starting the program. The trial produced a statistically significant result on the primary outcome; but the secondary outcomes have not been made public.
If 510(k) clearance is granted the Akili app (and not Tali train) will become the first FDA cleared digital treatment for ADHD. Akili will then seek CTP codes for this; or quite likely new codes will be created for it. Someone will conduct a health technology assessment where cost effectiveness will be examined.
If the health technology assessment is positive, then US health insurers (and the US Medicare safety net program) will start covering it in their plans. The app will be incorporated into clinical treatment guidelines. With a reimbursement pathway in place and guideline inclusion Akili will begin making money (theoretically).
But there are a lot of ifs including whether the improvement of that primary outcome (a measure of attention) is deemed clinically significant. Nearly certainly that will require some positive secondary outcomes indicating functional improvement as opposed to simply the cognitive improvement in attention.
The market positivity for Akili I suspect stems from the idea that with the FDA stamp of approval, and a big wad of cash, they can essentially push out the dozens of smaller players with non-evidenced based “brain training” apps (such as Tali train) and capture this market. And there are plenty of them:
You need to read very carefully the language on the Tali train web-site. You will read that attention difficulties are a key feature of ADHD. Next you will learn that Tali train is scientifically proved to help attention problems. So the lay person will reason that if Tali train is proven to help the key feature of ADHD then it must be a proven treatment for ADHD.
Wrong.
Behind every good pump and dump on the ASX is a simple misunderstanding by retail speculators.
Here the market misunderstanding is that health dollars flow to people who have problems. They don’t.
Health dollars flow to treatments for diseases or disorders with specific diagnoses.
This is the reason that Akili has spent millions of dollars on a P3 trial trying to demonstrate effectiveness for a diagnosable condition. As opposed to simply claiming its device helps children improve their attention.
It is the reason that RAP spent millions of dollars on two US trials to get FDA clearance to market its device as an aid for the diagnosis of respiratory diseases in children.
It is the reason the NTI ran a trial for its FDA listed neurofeedback device in order to support a treatment claim in children diagnosed with ASD; as opposed simply as a “relaxation device.
It’s the diagnosis bit that gets you the health dollars.
Not sure about all this?
No problem just give the Tali train people a ring first thing Monday and ask them whether tali train been approved by the FDA as a treatment for children diagnosed with ADHD? Or ASD? Or in fact any diagnosed condition? Simple questions that have yes or no answers.
In terms of Tali detect? Same deal. Tali detect is designed to provide a screening for children who have attention problems. There are dozens of these programs around of little to no commercial significance. If you want a FDA cleared (through the 510(k) pathway) digital aid for the diagnosis of ADHD there is only one – from Qbtech.
for assessment and not for treatment?
(20min delay)