Well I must say that in the beginning when I first became aware of the completion of the study I was excited (still am) the abstract is groundbreaking, a scientific breakthrough for ASD sufferers in its own right! The one disappointment for me is the size of the study to make it statically significant. Let's face it the reason this was originally conducted was to obtain proof in order to lodge to the FDA for clearance. But when one considers the fax that it is being published proves to me that the findings hold merit. Remember changes were observed in all three areas, but not in the control group. That is HUGE compelling evidence that it works. Yes this study was small but the results are still statistically significant based on those factors.. HUGE! "Using our readily accessible, home-based Mente Autism treatment can have a wide ranging and beneficial impact on children with autism spectrum disorder (“ASD”, or “autism”), across the modulation of brainwaves, behaviours and even balance.
I personally called management to discuss this topic they advised that they will not make any decisions yet whether or not they will be proceeding to lodge to FDA until all results from the study are made available to analyse. So it is still possible folks. LOL I even took the Liberty to call the FDA Direct to ask a bunch of questions -I was on hold for ages and got diverted 3 times in the end I had to hang up and chose to use a more Hi Tech method and email hahahaha. I personally prefer a conversation over the phone any day of the week - my fingers are too fat to type
The company is intending to lodge for a class 2 medical device, 510K application.
Mente 2.0 already has FDA clearance but to make additional claims the device needs to be cleared. The FDA will take this into account as well as the fact that the device has already got TGA and CE clearance. the data from the other studies will also help. It's also good that the US study was double-blind and independent. So there may be enough evidence to lodge after all...
We wait in anticipation for the detail of the fully published results. IM EXCITED
Cheers
Red bar
