They hired Emergo as regulatory consultant in USA to ensure they comply with all regulations. Also from page 6 of annual Report:
Neurotech’s pre-submission package for Mente Autism was filed with the FDA in March, subsequently followed by a meeting with the FDA panel of experts in June, who provided vital feedback on Neurotech’s regulatory and clinical plan to support FDA clearance of Mente Autism.
Based on the feedback received during this meeting, Neurotech will seek to market Mente Autism as a Class II regulated device in the United States (US) under the traditional 510(k) submission route. Neurotech is targeting final submission to the FDA by early 2018.
So I’m pretty sure they have all bases covered.
NTI Price at posting:
21.0¢ Sentiment: Hold Disclosure: Held
