Lets hope your right champ Rap has worked very hard to get this...

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #

First 8 Last

Share
Profile

Follow
Thorr

63 Posts.

28

11/03/20

17:38

Post #: 43432398
Share
Originally posted by AlCp: ↑

Clearly the FDA has done this so RAP has been informed that it was rejected due to "The probable benefits of the device do not outweigh the probable risks" and not safety and effectiveness.....if RAP explain this more probably tomorrow back to 15c.

Decline

The FDA will decline a De Novo request if we determine that:
General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device; or
The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device; or
The probable benefits of the device do not outweigh the probable risks.
If the De Novo request is declined, the device remains in class III and the requester may not legally market the device. The FDA will issue a written order to the requestor identifying the reasons, which can include lack of performance data that warrant declining the De Novo request. The requester generally should either submit an application for premarket approval under section 515 of the FD&C Act or collect additional information to address the issues and submit a new De Novo request that includes the additional information.

Expand

Lets hope your right champ Rap has worked very hard to get this our results are perfect for the submission fda are clearly picking on every little thing of this product hopefully rap have a update on a plan of attack in regards to this! lets not lose hope but we have failed multiple times but its not the end!
RAP Price at posting: 8.1¢ Sentiment: Hold Disclosure: Held
2 Upvote

0 Great analysis

Reply

Top Stories

DRO

History repeats for DroneShield investors but carnage so far subdued

SER

Strategic Energy extends its QLD copper-gold frontier with Diamantina acquisition

Week 29 Wrap: ASX hits new all time high of 8,766pts ahead of Aug 1

PSC

Prospect's Mumbezhi Project puts it at the middle of copper's megatrend. And FQM just bought in

AII

A new NASDAQ listing for a key player in the global critical minerals space

STN

Saturn brings up seventh straight Apollo Hill upgrade on 'impressive' 300-hole drill run

SYR

Syrah jumps +19% as graphite tariff threat spurs optimism down under

HotCopper Highlights: Trigg; Droneshield; Lumos & more

Listen: HotCopper Wire Podcast 018 – Potatoes, TACOs, and the $120M helicopter heist

BDM

Burgundy plunges -20% after turning to layoffs to navigate record-low diamond prices

First 8 Last

Add to My Watchlist

What is My Watchlist?

A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.

Lets hope your right champ Rap has worked very hard to get this...

Top Stories

History repeats for DroneShield investors but carnage so far subdued

Strategic Energy extends its QLD copper-gold frontier with Diamantina acquisition

Week 29 Wrap: ASX hits new all time high of 8,766pts ahead of Aug 1

Prospect's Mumbezhi Project puts it at the middle of copper's megatrend. And FQM just bought in

A new NASDAQ listing for a key player in the global critical minerals space

Saturn brings up seventh straight Apollo Hill upgrade on 'impressive' 300-hole drill run

Syrah jumps +19% as graphite tariff threat spurs optimism down under

HotCopper Highlights: Trigg; Droneshield; Lumos & more

Listen: HotCopper Wire Podcast 018 – Potatoes, TACOs, and the $120M helicopter heist

Burgundy plunges -20% after turning to layoffs to navigate record-low diamond prices

Featured News