I agree with your analysis CT,
I think one thing holding them back from establishing deals with Telehealth partners embedded with the clause 'subject to FDA approval' is because they cannot actually market without FDA approval?
From the De Novo Guidance:
If the submitter demonstrates that the criteria at section 513(a)(1)(A) or (B) of the FD&C Act 101 are met, we will grant the de novo, in which case the specific device and device type is 102 classified in class I or class II. The device may then be marketed immediately
(bold my own)
- Forums
- ASX - By Stock
- RAP
- Ann: RAP Licenses Additional Pneumonia Diagnostic from UniQuest
Ann: RAP Licenses Additional Pneumonia Diagnostic from UniQuest, page-158
-
-
- There are more pages in this discussion • 49 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
AVH
Avita boosts skin restoration product portfolio with 'dermal matrix' – a kind of next-level gauze made of fake skin
GML
Gateway Mining sells WA Eastern Montague gold project to Brightstar for $14M – half of that in shares
Add RAP (ASX) to my watchlist
(20min delay)
|
|||||
Last
20.5¢ |
Change
0.000(0.00%) |
Mkt cap ! $176.2M |
Open | High | Low | Value | Volume |
0.0¢ | 0.0¢ | 0.0¢ | $0 | 0 |
Featured News
STX
Strike hands $48.5M contract to Clarke Energy to produce 20x 4.5MW gas engines for Sth Erregulla
KAI
Pilbara Minerals buys land off Kairos part of its York gold project for $20M – and a 2% royalty on any PLS gold sales
GML
Gateway Mining sells WA Eastern Montague gold project to Brightstar for $14M – half of that in shares
RAP (ASX) Chart |
Day chart unavailable