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

When Resapphealth know they have the right stuff...they are...

First 36 Last

Share
Profile

Follow
Myeverywish

3,464 Posts.

956

17/02/22

10:55

Post #: 59631257
Share

Originally posted by MyBentley ↑

"We received feedback from the US Food and Drug Administration (FDA) on ResAppDx in March 2020. The FDA had not approved our request for De Novo classification of ResAppDx and required
additional information to demonstrate that the probable benefits outweighed the probable risks. During the year we have been working with our regulatory consultants to formulate a detailed response to the FDA’s comments and are confident that we have identified a path forward. Our next step will be a Pre-Submission meeting with the FDA to discuss this response and we expect
to submit a meeting request with the FDA shortly."

Getting close now...after FDA meeting on the morning of the last conference call...
All positive too toward FDA approval of Sleep Check

I am loving this journey.
Keep up the great work Resapphealth team

MB

Expand

When Resapphealth know they have the right stuff...they are passionate and never give up.

FDA process still happening still positive and moving forward.

Sleep Check is also positive and moving forward with great passion and great data...

Go RAP team...

MB

RAP Price at posting: 7.6¢ Sentiment: Buy Disclosure: Held
3 Upvote

0 Great analysis

Reply

First 36 Last

Add RAP (ASX) to my watchlist

SPONSORED BY