Hi all,
It's disappointing to see this news today, definitely not what we were expecting. Like many others have stated, you gotta wonder how can the same product be both CE and TGA approved, only to be rejected by FDA? I'm puzzled as to what 'risks' that could significant outweigh its benefits and led to rejection. I believe there's more to the story behind the scenes and it might be the US trying to look after their own interests. It'll be good for the BOD to do some Q&A with its shareholders to further understand the rejection. No doubt today's SP will be hammered but having both CE & TGA approvals, it actually makes me think there's an issue with FDA, rather than RAP's product.
As stated in the announcement, RAP will meet with FDA in person and hopefully resolve any doubts the FDA review team has for the product.
To me, this feels different than the failed clinical trials years back. Because now we have proven algorithm that's actually working and can be used for other commercialisation opportunities in Europe and Australia. All the best to fellow Rappers.
GLTAH.
- Forums
- ASX - By Stock
- Ann: Update on US FDA De Novo Classification Request
Hi all,It's disappointing to see this news today, definitely not...
-
- There are more pages in this discussion • 268 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
(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
RAP (ASX) Chart |
Day chart unavailable
The Watchlist
CCO
THE CALMER CO INTERNATIONAL LIMITED
Anthony Noble, CEO
Anthony Noble
CEO
SPONSORED BY The Market Online