Replies to post #194015 on Vivos Inc (RDGL)

[User-499230]

"As part of our IDE application process"?

IDE approval mid 2026?

Does the fate of Vivos now rely on the India government to approve human clinical trials toward commercialization in India?

Am I reading this wrong or is Vivos' PR not written well?

[imanjen13]

This is good news for cows.

[User-499230]

An update on DCGI's decision to allow Vivos to conduct human clinical trials towards commercialization in India likely in mid October 2025 to mid November 2025.

If...IF...Vivos needs to do more human clinical trials in India to gain IDE approval (I'm still NOT 100% sure if that is the case) than Drugs Controller General of India (DCGI) approval and Vivos Scientific India operations in GENERAL are significantly more important to Vivos than IDE approval at this point.

We know that Vivos has been pursuing an expanded permit from the DCGI to conduct clinical trials for commercial applications in India since at least 30 June 2025 based on the.

DCGI must decide to approve or decline Vivos' application within 90 working days from the application receipt, based on online sources.

An update on DCGI's decision to allow Vivos to conduct human clinical trials towards commercialization in India likely in mid October 2025 to mid November 2025.

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GO VIVOS INDIA GO!!

[IPSO_FACTO]

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.

So, ph2 protocol needs to include full body post treatment PET scan versus the treated area only? Based on what we've seen from the treated animals to date as well the female human patient, radiogel most likely will pass the full body scan with no issues.

[hotmeat]

Per the statement below from the Pr.....its either the intent of the FDA is to utilize the India trials as the basis for evaluating the safety profile of Radiogel thus possibly reducing the need for US based Phase 1 trials, OR, they're a bunch of buffoons for requiring Vivos to painstakingly gather extensive safety data so they can then grant us IDE which permits Vivos to finally commence Phase 1 safety trials in the USA, to collect the selfsame safety data. .

Seems pointlessly redundant IMHO..................



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.

[konshe]

This is a very good news For RDGL's success. PPS should following the news to begging going up step by step, once DCGI (Drug Controller General of India) approval for additional expanded human trials in India. Then we will see PPS going up to 0.50 to $1. Meantime if RDGL go into China to do human trial be approved before US, then the PPS will explode multi dollars.