Vivos Inc (RDGL)

[frz954]

Here's a list of approved de novo applications (link provided below).

As you can see, the ones who were submitted more recently had a quicker response than the ones submitted long time ago.
The second and third one from the top are great examples; especially the third one (submitted Oct 1st, granted Apr 1st, which is exactly 6 months).
We're due and should be hearing something soon. People who say this could take years are wrong! De novo applications no longer take years. The average time to respond has been decreasing. We're right on track. Don't pay attention to all the noise going around.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm