Ann: TGA Approval for Paediatric Respiratory Disease Diagnosis, page-20

ResAppDx-EU recently received CE Mark approval in the European Union for both adult and paediatric use, and is currently pending De Novo classification for paediatric use in the United States. A follow-on TGA submission for adult use will be made shortly.

This wording is alarming. It suggests we are not classified as a De Novo yet? FDA approval may be a fair way off if we have not begun the De Novo approval pathway. Thoughts?