Ann: Update on US FDA De Novo Classification Request, page-30

Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #

First 30 Last

Share
Profile

Follow
fattchoi

6,767 Posts.

4475

11/03/20

10:17

Post #: 43420966
Share

Originally posted by Red bar ↑

Not good, they're loss, bunch of wankers it's smartphone software for Christ sake!

"additional information is required to demonstrate that the
probable benefits of the device outweigh its probable risks." Nothing but negativity towards our device regarding anything that this company does in the United States. I can't believe that this decision has been made particularly during these elevated times of the coronavirus unleashing havoc throughout the world. Seriously the FDA need to revise this decision. Our company needs to appeal and take this to another level!

I'm disappointed that even though we had experience group backing us up with their 99% track record all of the positive vocabulary from the FDA positive spin from Morgans and still I know go... it's just does not make any sense at all!!! Thankfully we have sleep apnea to fall back onto and clearances already in place in other regions.

Commiserations RAPpers... I will be loading up not selling!!

Cheers

Red bar

Expand

Management should take a leaf off what PCK has done. Go local. Get a foundation going on here first. Ignore everything else. Once it is going well here with great result, other countries will come begging. Stop flying around to US or China or anywhere else.

I truly weep for the great products we have. Now with this rejection, it is going to be much harder to convince any takers now.

RAP Price at posting: 6.5¢ Sentiment: None Disclosure: Held
45 Upvote

5 Great analysis

Reply

Top Stories

SHN

Sunshine Metals kicks off copper gold drilling at Truncheon; Highway East targets

IMA

Issues emerging as Australian companies tackle critical minerals challenge

Tonight's US CPI data could set the tone for November. What are markets expecting?

ASX Market Open: ASX200 to open flattish after Wall Street weakens on hot US inflation data | October 11, 2024

NWH

NRW Holdings inks $109M deal with BHP for works at Jimblebar

ARV

Smallcap Artemis Res' jumps 23% on six digit gold grade rockchip find at Titan

ARB

Court process clears way for ARB to buy up 4 Wheel Parts business in the US

MKT

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

OCT

Octava Minerals joins the antimony train with high-grades on the radar at Yallagong, WA

RAG

Ragnar impressed by 11.55 metre pegmatite in Sweden, anticipating further mineralisation

There are more pages in this discussion • 288 more messages in this thread...

First 30 Last

Add RAP (ASX) to my watchlist

Ann: Update on US FDA De Novo Classification Request, page-30

Top Stories

Sunshine Metals kicks off copper gold drilling at Truncheon; Highway East targets

Issues emerging as Australian companies tackle critical minerals challenge

Tonight's US CPI data could set the tone for November. What are markets expecting?

ASX Market Open: ASX200 to open flattish after Wall Street weakens on hot US inflation data | October 11, 2024

NRW Holdings inks $109M deal with BHP for works at Jimblebar

Smallcap Artemis Res' jumps 23% on six digit gold grade rockchip find at Titan

Court process clears way for ARB to buy up 4 Wheel Parts business in the US

The ASX can overlook its Telecomm small-caps. Here’s one diversified brand with an international footprint

Octava Minerals joins the antimony train with high-grades on the radar at Yallagong, WA

Ragnar impressed by 11.55 metre pegmatite in Sweden, anticipating further mineralisation

Featured News