Vivos Inc (RDGL)

[DPep]

That sounds like the most likely scenario, except, they may get the green light for accepting the application, then the 30 day count down begins. Remember, they filed a pre-submission application which was reviewed at the November meeting. I am assuming they also filed a pre-submission for this review of the dosimetry changes, so they can spend the time discussing the topics and not spending it reading.

I am hopeful that this meeting covers all of the open ends, and then can be submitted.

Best possible situation is that they have had the new application for a couple of months, have performed their review, and are good with the changes and feel it can be accepted as it is.