Vivos Inc (RDGL)

[SC8]

Wrong. The BDD application failed in January 2021, after which MK made two forecasts for IDE submission that year. The first was within 2nd quarter 2021, which he withdrew on May 24, 2021, saying he needed another 90-120 days, aka no later than Sept 21, 2021. He never withdrew that 2nd forecast, but rather pulled a bait and switch by announcing entry into FDA's pre-sub program on Sept 20, 2021.

As far as FDA pre-sub hand holding helping, that only helps if one takes their suggestions, rather than resist and foot drag against those suggestions. MK wasted over a year resisting FDA suggestions for a better IDE application.

So yes, we'd be much further along if MK had entered the pre-sub program immediately after the failed BDD application and not resisted FDA upon doing so, much that's not what happened. He entered the pre-sub program 8 months after the failed BDD application and then wasted over a year resisting FDA at almost every turn.

Facts are facts.