Vivos Inc (RDGL)

[LeAcc]

Why do you all continually choose to ignore the company stating that they are confident they have submitted 90-95% of the required data. It’s not the end of the world, it just needs to be addressed. But calling this an extension due to the FDA not being able to review enough of the data is laughable.

The inability to address the questions posed by the FDA within the interactive 30 day review period is the reason it was converted to a Pre-Sub.

Vivos ASKED for the conversion, and the FDA granted it, likely because the small amount of additional information being requested could conceivably be compiled in a relatively short period of time. The studies are done, the work is done, the analysis needs to be refined.

It’s far from the end of the world, but you come across as delusional and / or insincere when you try to manipulate the wording to sound like this is all on the FDA.