Vivos Inc (QB) (RDGL) News

https://vivosinc.com/quarterly-reports

ISOPET Record 1st quarter growth increase 150%

Just citing the facts regarding MK's proven serial lying and general incompetence. You can't refute the cited facts, so you make false and irrelevant ad hominem accusations instead. Not my fault RDGL has been at this for decades and in all that time never made a serious effort to get Radiogel to market before all the original patents expired. The tech is public domain now. Those are just facts. The facts are what they are.

Great step by the FDA 2.0 under RFK.......let the institutional reform continue post haste!!!!!



FDA bans Petroleum based Food Dyes

Comment the phrase "SAD LIFE" if you think one of the posters on this board is a total JOKE

FACTS. Great post. 

You are a loser who has no life. Absolutely no one on this board agrees with you. How amazing is that. I'm just glad my 'ad hominem' response made you wast another 20 minutes of your sad life. Rooting against a company that has a therapy that successfully kills cancer-- man you are a piece of work 

It's a generally accepted fact that persons who resort to creating multiple online personas in order to give credulity to their narrative are not trustworthy individuals.

sceeate immediately comes to mind. lol

Was your assessment re Vivos based on the extensive knowledge you acquired in the last few days, OR, was it predicated on the 25 years you worked (LIE) in Chinese Tech!?!?!

Defending sceeate is very admirable........"birds of a feather" obviously!

No Frenchy, the CEO is wonderful--- hence the India trials. Without Dr K no trials in India would be happening.

SC8 = French King of gaslighting.

I am so happy you learned a new word ad hominem, unfortunately, you are not using it correctly.

Your continued false ad hominem accusations don't change the facts regarding RDGL serial lying CEO and his long demonstrated general incompetence dealing with FDA. The guy is inept. It's just a fact.

What lies have I told about RDGL? Are you denying that:

Phase 1 Indian trials have been going on for months now, and to date MK has only revealed one anecdote about one of the initial five patients, and in that case the treated tumor survived 30 days post treatment?
MK made absurd claim that the 5 initial trial patients in India with metastatic cancer are “doing well”?
Dr. Fisher so fubared the rabbit tests in 2021 they had to be repeated at JHU in 2023 and it appears MK fubared those too, since to date he hasn’t submitting rabbit results to FDA (withdrawn IDE application doesn’t count)?
After years of pre-sub discussions, MK so fubared the June 2024 IDE application, he withdrew the application?
MK said in July (after withdrawing his fubared IDE application) that he was confident the application would resubmitted within 45 days, then earlier this year he said 2nd quarter this year, now he’s saying 3rd quarter this year?
MK failed to get Radiogel to market before all the patents he licensed from Battelle expired and the tech became public domain?
MK lied in May of 2021 about submitting IDE application within 90-120 days (by Sept 21, 2021)?
MK failed to document and safely store gel formula/procedure, so the know-how was lost in 2021. As a result RDGL couldn't supply IsoPet for most of 2021 and had to start over with FDA?
MK lied on multiple occasions he had enough cash on hand to get through IDE approval, only to have each lie followed by an offering?
MK dishonestly makes post release edits to updates without indicating they're edited or the edit date?
MK lied in 2023 that the JHU rabbit testing had concluded when it hadn't?
MK took most of a year to write up the JHU rabbit results after saying it would take six weeks?
MK has repeatedly made unsubstantiated product attribute and comparative safety claims, with no evidence whatsoever, putting everything he says and submits to FDA under a magnifying glass?

The tech is public domain now. There is no evidence MK's patented "improvements" yield any performance advantages over what RDGL did before 2022.

Incorrect. There are no current fuck ups with the FDA .

I also just noticed you reactivated another lying handle Poop deck Pappy, after I mentioned it.

Silly Frenchy!!! :)

Wrong!!!! Human trials in India signify talented leadership.

The best is yet to come. RDGL = Bright Future

The only bogus conclusions are those you post on here that are based on your wholly unfounded opinions.

You have a penchant for fabricating talking points.

Couple billion as the cancer market is mammoth 

Agreed 

Doesn't change the fact that you are a broken record and have ruined this board with your constant lies and negativity. Everyone is sick of your crap. Go away 

buy what you can.. may be one of the last opportunity to get cheap'ish shares (below 10cents)

What, then, would you say the correct valuation to be?

This company is massively undervalued 

You just proved my point good job from hung lo by the head idiot which of course we all know as a fact

They really make you wonder or wander ...???

Let's go RDGL

They really make you wonder or wander ...???

Let's go RDGL

The Shit Chute >>SC. It just keeps on cranking it out>>same continuous crap for yrs. now— as we all know. LOL.

No end in sight for anemic pps & volume until we get results submitted from India…

Nothing worthwhile ,worth having in life, comes easy huh?


RDGL$$$.

The only bogus conclusions are those you post on here that are based on your wholly unfounded opinions.

You have a penchant for fabricating talking points.

You're false ad hominem accusations are both off topic and don't change the facts regarding inept leadership at RDGL.

Are you denying MK's multiple f-ups dealing with FDA?

The facts are that MK has been running RDGL for nearly a decade with f-up after f-up. Is it really a surprise it looks like he f-up the India trials too? Hard to comprehend the incompetence of his only now realizing he needs operations reasonably close to any human trial (or he could go back to the 2 pack version before his "improvement" and have Y90 part toll manufactured in India). Then again, neither he or Dr. Fisher were aware Y90 emits enough positrons to light up on PET scan; FDA had to point that out to them. Again, just f-up after f-up at RDGL.

Listed and actual as he pointed out is NOT ALWAYS TRUTHFUL

DAY do dat chit all the time

You are great at non truths. There is a reason you're unemployed. 

You make no sense. I'm hoping you didn't have a stroke, because you are in lala land.Libel is real stingray.. 

You keep repeating the same talking points, but they’re built on conjecture, not facts. Saying “it’s all irrelevant until FDA sees results” is an easy dodge to dismiss everything the company has done—regulatory approvals, clinical logistics, protocol design with FDA input, and collaboration with Mayo Clinic.

Calling this “bait and switch junk science” is pure fiction. The SEC filings confirm that the exact product intended for market is being tested, under a protocol shaped with FDA feedback. That’s not your opinion vs mine—it’s black and white in the legal record.

Your claims about “screwed up animal studies” are equally baseless. Applications get withdrawn and refiled in this space all the time as part of an iterative process with regulators. That’s how responsible companies refine their data, not a sign of failure. You don’t know what was submitted, what the FDA said, or what changes were made—so let’s not pretend otherwise.

The India trial is proceeding under approvals from multiple regulatory bodies. That’s not a side project—it’s a controlled, compliant effort designed to generate the safety data needed for an IDE submission. If you’re going to call that “junk science,” you’d better bring something stronger than speculation.

All irrelevant until results are submitted to FDA. Theirs are the only opinions that matter for USA market.

Based on what I've seen to date from RDGL, it's bait and switch junk science out of India and FDA will reject the safety conclusions as invalid. Or MK will delay submitting IDE until RDGL has operations in India and can run valid controlled trials of product they actually intend to market. Time will tell.

Too bad by all appearances he screwed up the prior animal results (Never submitted to FDA. Withdrawn applications don't count) and now seems to be doing same with humans in India. Again, time will tell, but MK's track record here is very poor.

It is what it is.

You keep repeating the same narrative without actually demonstrating any real understanding of Y-90 products or regulatory trial design. Let’s be blunt—your grasp of Y-90 logistics, regulatory compliance, and clinical trial execution is zero.

Cuz I know enough about Y90 products to know how to run a valid trial with product they one intends to market, not an aged water down product one doesn't intend to market. And the publication of results, just like the JHU Vet school rabbit study, are irrelevant. Only opinions that matter here are those of FDA reviewers, and we know they don't take BS. Gotta compare apples to apples with FDA.

Your take completely ignores the documented regulatory process and instead repeats unfounded speculation. The “bait and switch” narrative is baseless. 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.

How do you know this when the study, trial format, and data haven't been released yet? 

Not sure what your point is. None of this matters until results are submitted to FDA. Based on what I've seen to date from RDGL, it's bait and switch junk science out of India and FDA will reject the safety conclusions as invalid. Or MK will delay submitting IDE until RDGL has operations in India and can run valid controlled trials of product they actually intend to market. Time will tell.

By all appearances, MK screwed up the repeat rabbit studies (never submitted to FDA), and is doing the same in India. It is what it is.

On a side note, per MK, the Indian physicians are improvising application techniques and that is being shared with Mayo. That clearly is an unexpected deviation from plan, if there was a plan.

Your post completely ignores the facts disclosed in the SEC filings and misrepresents the situation on the ground. The clinical trial protocol was developed with explicit FDA input and incorporates study design elements from Mayo Clinic. That’s not speculation—it’s documented. This protocol governs the trial in India, and it's being executed under the oversight of multiple regulatory bodies, including the CDSCO, Ethics Committee, and Scientific Committee. That level of review and approval is not granted lightly.

Claiming the trial is being improvised or that the company is incapable of running a proper Phase 1 study is flat-out wrong. The logistical execution—radioactive licensing, international shipping compliance, liability insurance, and device validation—is a clear indicator of the company’s thorough and professional approach. This isn’t a backyard science project. It's a regulated clinical trial involving radioactive isotopes and international oversight.

And let’s be clear: SEC filings are legal documents. Accusing the company of lying in those filings without a shred of evidence is not only reckless—it’s potentially libel. If you have proof, bring it. Otherwise, spreading baseless claims damages the integrity of the conversation and undermines serious investors.

We have no idea what the FDA or Mayo input was or how much of that input is actually used in the India "study" plan or if the plan is still being followed. Per MK, the Indian physicians are improvising. Does it even matter? Very clear they can't even do a competent phase 1 safety study remotely, let alone phase 2. They need operations near human trial to test the product they intend to market.

Maybe there's Indian investors that can bail out RDGL to get competent trials going? The dilution will suck, but what other choice is there? At moment RDGL needs more cash to set up operations in India or they need to abandon this "trial".

Sorry, have only posted on ihub as SC8. But even if I was using multiple handles, what's your point? I'm not the topic, RDGL is.

So why in your opinion has RDGL been at this for decades and has accomplished nothing while supposedly inferior Y90 products have long been on market? How did competitor Betaglue get a 2.5 year head start on human trials?

Occam says incompetent management.

Try running bogus safety conclusions by FDA based on a different product dose (aged watered down product) than what one intends to market and see how many more years one can flush down toilet. MK acts like he has forever. He doesn't. None of us do.

He needs to stop giving FDA reasons to say no, yet that is all he does. Mental illness?

Vivos has clearly integrated regulatory feedback into its clinical trial design. The SEC filing explicitly states that FDA input was incorporated into the trial protocol—covering critical aspects such as the transportation of RadioGel®—ensuring that the exact device intended for approval is rigorously tested rather than a diluted version.

Far from a "bait and switch," the company has implemented a methodical, step-by-step approach. Approvals were secured from multiple regulatory bodies in India, including the Scientific Committee, Ethics Committee, and the Central Drugs Standard Control Organisation (CDSCO). They finalized the Clinical Trial Protocol with input from both Mayo Clinic study designs and FDA pre-submission discussions, confirming that the process adheres to the stringent standards required for testing the device as approved.

Moreover, the extensive logistical preparations—ranging from liability insurance and radioactive material licensing to international shipping protocols and contingency plans for the Yttrium-90-based product—underscore the company's commitment to operational excellence.

It's also important to address the rhetoric sometimes used in these discussions. Accusing someone of lying in a SEC filing is a serious allegation that can have legal ramifications, potentially amounting to libel if not substantiated by clear evidence. SEC filings are legal documents subject to rigorous review and oversight, and any discrepancies are typically addressed through established regulatory processes. Baseless or unverified allegations could expose the accuser to legal challenges, diverting focus from substantive discussion.

tick tock

What you said regarding MK is not a fact.

You are a Dishonest manipulator of facts-- Loan Ranger

More pointless opinionated rubbish from sceeate

Efficacy is not a clinical endpoint in Phase 1...the proof is crystal clear so the fact you keep insisting on this garbage only proves my point.......100% LIAR!

Or moronic MK only just realized he can't do a valid trial in India without operations there as Y90 products have no shelf life.

Again, efficacy and safety when it comes to medical radiation devices go hand in hand. Moreover, can't pull a bait and switch with FDA. Gotta test the device one seek approval for, not a watered down aged out version.

How many years is MK gonna waste this time arguing otherwise with FDA?