Ann: 2019 Letter to Shareholders, page-3

From the letter
"Potentially, the next regulatory milestone for ResAppDx is approval in the United States (US).
After completing our SMARTCOUGH-C-2 study, we submitted a De Novo classification request to
the US Food and Drug Administration (FDA) in April this year, and this submission continues
through the review process. We are encouraged by the positive interactions with the FDA as we
work with them through their review."

No firm date but strong language IMHO to say RAP expects it to be approved.