I NO LONGER believe that Vivos resubmtting the IDE is dependent upon DCGI approving Vivos to begin human clinical trials towards commercialization in India.
It is possible Vivos resubmits the IDE to the FDA to begin human clinical trials in the US later this month (October 2025) in order to get a decision before the US winter holidays. I have nothing else to back said thought. Either way, in general, again, I think that the IDE resubmit is still on track, all data has been gathered to support the IDE application, and the FDA consultant is making or has MADE the necessary edits for FDA approval.
A Vivos update on Drugs Controller General of India's (DCGI) (India) decision to allow Vivos to conduct human clinical trials towards commercialization in India is likely to be released between mid October 2025 to mid November 2025 or ANY (WITHIN 90 working days of receipt of application which likely occurred around 30 June 2025, according to Vivos' 2025 Q2 Form 10Q) DAY now!
Vivos has NOT stated that DCGI approved human clinical trials will be impacted by Vivos' lack of a RadioGel and IsoPet manufacturing center outside of the US. Vivos HAS stated that Vivos intends to establish its first international RadioGel and IsoPet manufacturing center to support COMMERCIAL treatments for humans and animals in India and in other global markets.
The Vivos 29 September 2025 press release states the following: "...our [Vivos'] long-term plan of establishing our first international manufacturing center for RadioGel and IsoPet, for expanding our developmental animal testing, and for commercially treating humans and animals in India."
Additionally, Vivos' stated in its 4 February 2025 press release: "Simultaneously, we are evaluating additional manufacturing partners in India and other regions to support global supply chain expansion." The aforementioned decision is very likely going to be a stopgap until Vivos' first international manufacturing center for RadioGel and IsoPet comes online.
Again, I'm very glad that the DCGI is in the midst of improving its regulatory framework to align its ENTIRE program with global standards right before Vivos potentially receives DCGI approval to begin human clinical trials towards commercialization in India and to support the FDA process in the US.
Really good timing.
Two separate approvals in relatively quick succession would be really nice.
Ignore the noise from the Village Idiots located on the Island of Misfits. They have become even more stupid and aggressive.
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GO VIVOS GO!!
GO VIVOS INDIA GO!!
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