Australia's largest stock trading and investment forum Australia's #1 stock forum

RAP

Click for more information

0.00%

20.5¢ resapp health limited

Ann: Update on US FDA De Novo Classification Request, page-58

First 58 Last

Share
Profile

Follow
applesanddiamonds

610 Posts.

141

11/03/20

10:35

Post #: 43421595
Share

Originally posted by eason2946: ↑

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.

Expand

100% Agree.
I am a long term holder and I just bought a bunch more...

RAP Price at posting: 6.9¢ Sentiment: Buy Disclosure: Held
10 Upvote

0 Great analysis

Reply

Top Stories

Week 29 Wrap: Trump in spotlight again; China's Third Plenum a yawnfest; RBA's August move a mystery

Talking Australia's very competitive property landscape: Realty Talks

FG1

Flynn Gold flags mid-grade drill hits and always eye-catching rock chips

Warren Tredrea’s weekly sports business wrap: the latest on business in sport

GNX

NSW approves J-POWER's $380M buyout of Genex Power, giving it ownership of QLD net zero project

MCT

Metalicity looking for offers on Admiral Bay zinc project

AI stocks: What to expect in 2024-25

IMR

Imricor raises $35M to pursue growth and expansion into Australia and NZ

LKE

Lake Resources implies news article on job cuts made up; non-core sales "not material" and no rule 15.7 breach

Wealth Within considers potential takeover targets in Australia's booming infrastructure industry

There are more pages in this discussion • 260 more messages in this thread...

First 58 Last

Add RAP (ASX) to my watchlist