Ann: Annual Report to Shareholders, page-43

We already have FDA approval for the prizma, waiting for fda approval for the patch (which should be a PMA application I believe and takes longer, 510k is a cake walk). But yes we are all waiting for CFDA approval for the prizma as that’s what the big heavy MOUs are based on.

To answer your question, yes you can have studies outside of the US for fda data. I monitor a few pharma studies here in Aus which are all for fda submissions.

Like others on this forum, I also agree that in the longer term the patch and the service revenue it may bring seems really unbelievable. Excited time ahead for healthcare! And us holders.

Thanks,