Bluesky why do you think that approval is only a few weeks away. The way I read the announcement on MEBsleep (501K) is that the clarifications they are receiving from FDA are a preface only to allow FDA to "start" their review of the submission. Doesn't that process take 6-9 months once it starts?
What am I missing here?
Ann: FDA Strategy and Regulatory Update, page-88
-
- There are more pages in this discussion • 76 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
