Replies to post #156511 on Vivos Inc (RDGL)

[rtg123]

Here is the most favorable timeline for Phase 1 of the rabbit study:

Inoculation (with fresh VX-2 cells): ~ Jan 3th
Tumors of treatable size and Radiogel application: ~ Jan 17th
End of containment study: ~ Jan 27th

I doubt it went that fast.

[SC8]

We do know the consideration window after IDE application is 30 days. No comment from FDA means approved.

RDGL is in pre-submission discussions with FDA. There are no testing requirements, but rather suggestions from FDA of what would make for a strong IDE application. FDA may suggest more testing at 4th meeting, depending on results with current study.

What "several curve balls" from FDA? RDGL voluntarily entered the pre-submission discussion program over 16 months ago, and FDA gave them helpful and easily anticipated advice from first meeting onward. Not FDA's fault RDGL was late entering this program, and that we're still waiting on data 14 months and counting from FDA suggesting "specific additional testing". Radiogel is now multiple decades old technology. It's very reasonable for FDA to expect controlled direct imaging of Radiogel placement over ten days or so. What's surprising is RDGL not having that data many years ago, not FDA's expectation.

[judascoin]

Guesses on SP just after IDE approved?