Replies to post #188038 on Vivos Inc (RDGL)

[chereb19]

Your take completely ignores the documented regulatory process and instead repeats unfounded speculation. The SEC filing explicitly states that the FDA provided input on the clinical trial protocol, and that exact protocol is what’s being executed in India—not some watered-down version. This includes specifications for the same device intended for eventual market approval. That’s not speculation—that’s regulatory fact.

[WALLnut]

You keep pushing the idea that RDGL missed its shot and is now limping around in a “generic business space.” But that’s either outdated thinking or willful spin, because the reality is very different in 2025.

1. This Isn’t a Commodity Market
Calling it “generic” ignores the most basic fact: there is no injectable Y90 gel on the market yet. Whoever gets there first defines the standard. RDGL’s one-pack, precision-targeted gel is leagues ahead of the old two-pack method you keep referencing—and that innovation is patent-protected. That’s how value is created in biotech.


2. Mayo and Telix Don’t Lend Their Names Lightly
You act like RDGL’s just paying Mayo to play along. That’s a lazy take. Mayo has reputational skin in the game and zero incentive to trial junk science. Same with Telix—why would a global oncology player waste time on something “generic”? Because they see what you don’t: a first-in-class injectable with real clinical upside.


3. The “Too Late” Argument Is Hollow
Biotech isn’t about who had the first idea—it’s about who gets execution and formulation right. RDGL didn’t rush half-baked data to market like others have. They took the hard road through FDA’s Class III device path. And now they’re weeks away from crossing the IDE line. That’s not failure. That’s precision.


4. India Strategy Is a Door-Opener, Not a Detour
Clinical data from India—especially through a partner like Karkinos—isn’t disqualified by geography. It’s judged by quality, and the FDA has accepted foreign data many times if it meets standards. RDGL manufacturing in India isn’t a weakness; it’s a smart global scale-up strategy.


5. MK’s Playbook Is Working
You keep throwing shade on MK, but look at the scoreboard: IDE submission finalized, FDA meeting done, Mayo locked in, Telix involved, Karkinos ready to launch trials. That’s what real leadership looks like. It’s not flashy—but it’s working.



RDGL’s not trying to compete in a generic commodity race. They’re building a precision oncology delivery platform. That’s a billion-dollar space. Whether they sell, scale, or partner, the upside absolutely still exists. And it looks like they’re finally executing.

$RDGL