Vivos Inc (RDGL)

[rtg123]

You seem to forget what happened:

- RDGL submitted draft IDE
- At meeting FDA requested an additional meeting to discuss containment and dosimetry
- RDGL most likely submitted all data available, maybe even from the Batelle days which may have taken some time to dig out (I have been involved in similar cases where we tried to make our point to the FDA by sending all we had).
- FDA did not considered the data to be good enough (not necessarily for the reason you keep bringing up ad nauseum) and requested more controlled data.
- RDGL worked out protocol with JHU
- RDGL submitted protocol and requested meeting
- FDA approved protocol

So where is the lack of focus? Some of the activities take time and Vivos is not Merck or Pfizer with nearly unlimited resources and personnel. Could they go faster? Probably. But I don't see a lack of focus.