Ann: PainChek receives FDA regulatory guidance, page-52

I think we are past the commercialisation hurdle with the health metrics deal. I would expect significant uptake in the RAC dementia population that uses eCase. Only thing I am not sure if this precludes them from accessing other providers, Which I don’t think will be case.

In respect to FDA, if you follow the hyperlink to breakthrough device in this article: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm441467.htm

You will see the Expedited Access Program for novel devices of which PainChek is one.

With respect to the trials, I am not sure how it will be run but i’d say it will be fundamentally different to RAP. Reason being your patient population is already presented and not needing to be recruited. This of course is not factoring in the required patient population size for FDA submission (if can’t use existing studies) and we will have the learnings from RAP to facilitate smoother pathway.

BPB.