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.
- Forums
- ASX - By Stock
- RAP
- Ann: 2019 Letter to Shareholders
Ann: 2019 Letter to Shareholders, page-3
-
-
- There are more pages in this discussion • 95 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add RAP (ASX) to my watchlist
Currently unlisted public company.
The Watchlist
I88
INFINI RESOURCES LIMITED
Charles Armstrong, CEO
Charles Armstrong
CEO
SPONSORED BY The Market Online