nti - in preparation of full results release, page-45

You seem to be a little under-informed @Dhm. If you have money in a stock - research, research, research!

Here is a link to the FDA approval process for Medical Devices:
https://www.fda.gov/MedicalDevices/default.htm

Here's the page to look at for info on CE marks:
https://www.google.com.au/search?q=...hrome.1.0l6.4125j0j8&sourceid=chrome&ie=UTF-8

CE Marks are not a big deal. Maybe taking a few months for the whole process. But you have to get them for various regions of the world, all through different "boards".

FDA is the USA approval system. Each country has their own comparative one but if you get through the US process other countries look favourably at applications. FDA approval is not a given, and it takes a significant amount of time. This is a really good document on clearance times for FDA approval:
https://www.emergogroup.com/sites/default/files/emergo-fda-510k-data-analysis-2017.pdf

My personal view is that a medical device that affects the brainwaves of children might be difficult to get approved, and that is the view of an educational psychologist I chatted to about it, but what would we know?