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. 🤞
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.