Vivos Inc (RDGL)

[rtg123]

"My point was animal test plan hasn't started yet as of today's date"

Sorry, can't change your story every time you're caught!

"Submitting a draft IDE to FDA for comment under pre-submission discussion program isn't submitting a real IDE application for their consideration"

Of course not! But they have submitted a document which was reviewed.

"FDA will only consider Radiogel human trials when RDGL submits an IDE application"

FDA IS considering Radiogel for human trials and this is why they recommend the EFS!

"nobody knows the degree of Radiogel containment within a tumor"

That is incorrect. They have data in rabbits, cats, and dogs. Maybe not exactly what the FDA wants to see, but they have data.

"That's why FDA suggested the test"

Do you really know why the FDA suggested the test? Were you at the meeting?