Ann: PainChek receives FDA regulatory guidance, page-47

This De Novo classification is a similar path to what RAP is taking. If RAP is anything to go by, this will be a long and expensive process. I don't see PainChek getting FDA approval before 2020.

At a meeting I had last year I enquired about whether they have budgeted for any US studies, management mentioned some funds had been set aside although they were confident approval would be granted regardless.

PCK should focus on the immediate commercial opportunity in Australia and Europe. After reading their quarterly, It seems like they are finding it difficult to prove the utility. Training staff at each facility is a timely and expensive exercise, especially if they are wanting to change data collection processes.

I sold out a while back and will watch from the sidelines.