Great news. Yes RAP did do a presubmission and it was determined they should go down the de novo path. Not sure punters are fully aware of this as it wasn't in the current ann...but has been mentioned in the past. Meetings with the fda to determine the path to be taken were held last year iirc.
Ann: ResApp Submits De Novo Application to the FDA, page-40
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
-
- There are more pages in this discussion • 68 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)