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Roofus

08/17/25 7:14 PM

#192131 RE: G_rokk #192130

October seems realistic.

We’ll have to wait and see.
Could take a little longer even, but I think we can perceive a resubmission in Q4.
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WALLnut

08/17/25 7:19 PM

#192133 RE: G_rokk #192130

Until MK has a meeting with FDA, I don't think he knows when next app will be submitted. It's all in FDA hands at this point. Hopefully we hear something from MK this coming week. 🤞



$RDGL
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AMB67

08/18/25 7:34 AM

#192154 RE: G_rokk #192130

Based on Vivos' updates, at the moment, mid to late September 2025 at the earliest.

The outcome of the pre-sub meeting with the FDA that will be held within the next three weeks from 14 August 2025 will very likely detemine when the IDE will be resubmitted.

GO VIVOS GO!!

Vivos' inital call with FDA is THIS week!
Bullish
Bullish