Vivos Inc (RDGL)

[Cameron12221]

"We had a Pre-Submission Zoom meeting with the FDA to obtain interim comments on our draft IDE. They used the equivalent of the rapid breakthrough review process to give the RadioGel review a priority. We are currently strengthening our IDE based on their feedback."

I believe also they mentioned not long ago that they're dealing with a new team of FDA reviewers, but I could be thinking of something else.

Also just a friendly reminder to everyone what was lowkey in the 2021-2022 PR:

"Our animal therapies have been in relatively large tumors, some as large as a half-pound. As part of our development plan to increase the addressable market for Radiogel™, we are developing a microinjection system to deliver relatively small volumes with precision. In addition to treating small human lymph nodes, this refinement will pay off in future indications for use that require precise microinjections, such as treating ocular melanoma, brain tumors, and spinal cancers."

Call it what you want, but I still don't believe they'd be working on this unless they were very confident about the future. I can't imagine it'd be cheap creating this for what they'll be using it for.