Sleepcheck now available on Android?, page-12

We had that pre-submission meeting with FDA in November for SleepCheck which was apparently very positive.

The November announcement stated that the human factors study will commence early this year with submission for prescription only device lodged hopefully by end of March and a decision within 90 days from there. That's all hopefully done by end of this financial year. Should be a much easier process than the Denovo approval that DX suffered through. Surely we are far more accurate than that Drowzle app that got FDA approval in July 2019.

Once that's done the company intends to do a clinical study in the US similar to what we did here in Aus so we can obtain DTC approval. I like the strategy of over the prescription only approval first. Speed to market!

If we get into the US with SleepCheck then we can have some interesting conversations with some big players.