Vivos Inc (RDGL)

[kayak_wench]

There is ZERO chance of IDE approval at the meeting on the 20th. The meeting is described as being to CLARIFY Yi-90 particle containment and dosimetry calculation technique. Those two tasks have been requested by FDA. Based on the description of the meeting either (1) Vivos can't figure out how to do them without more input from the FDA or (2) Vivos did them but the FDA has questions for them regarding how they were done.

Obviously the second is better than the first but in either case the FDA is not going to present findings based on the a meeting to 'clarify' things. They will take the information provided by Vivos at the meeting and resume their analysis or just tell them they have to do more at the meeting.