Oct. 20 at 10:58 AM
$RDGL The FDA has NOT requested Vivos to provide data from DCGI approved clinical trials in India. Vivos India efforts will ALWAYS support Vivos US through the ENTIRE FDA process meaning until approval to market in the US. The FDA process in brief: bench testing, pre-clinical trials, submit application to begin clinical trials, clinical trials, submit application to market product.
The following Vivos update is from Vivos' 29 September 2025 press release: "Based on feedback from the FDA, as part of our IDE application process, our formal protocol for the next phase of human trials in India will include immediate post treatment PET full- body scans to further validate RadioGel's safety profile". Said update is most likely on the Clinical Trial Protocol in general.
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Two separate regulatory approvals (FDA-US and DCGI-India) in relatively quick succession is possible and would be really nice.
GO VIVOS-US GO!!
GO VIVOS-INDIA GO!!
GO VIVOS-ISOPET GO!!