Vivos Inc (QB) (RDGL) 뉴스

Honestly most of my posts are usually sarcastic posts against what I feel is "deception" 

If I feel (assume) that someone is trying to deceive with their posts about  5000% 10,000% Gains, I get bothered and make sarcastic comments.

My same approach happened towards Vivos contradicting posts about timelines, it felt like we were being deceived and I got bothered and became sarcastic/whiny.

Like I said before, I don't have MK headshot as my screensaver, I do care for the science but like everyone else, I invested for Gains and for some of y'all 7-10 years could be a norm, but to me is an eternity. 

We all process information differently. From the beginning you got me mixed up with someone else, and you have been incorrect with your conclusions about why I post. Not trying to convince you. I could care less 

What you said makes no sense and is highly offensive to loyal long-term shareholders.
It's like telling a little child, its ok to put your face right in front of the mouth of an aggressive dog.
RDGL= Bright Future!!

Criminal organizations will be walking the plank when they are arrested for naked short selling and stock manipulation

I agree with you.

WRONG!!!!!!!!!!!!! That is a very bad thought because it would require a reverse split. Something that would stab loyal investors in the back times 1000.

In addition, uplisting would only help short sellers and criminal organizations. NOT LOYAL LONG-TERM INVESTORS!!!!!!!!!!!!!!!!!!!!!!
RDGL got to INDIA WITHOUT NEEDING TO UPLIST

They are killing cancer without needing to uplist. They could be bought out by big pharma without needing to uplist. And all the while long-term investors are PROTECTED!!!!!!!!!!!!!!

2faced gangs.......so facetious, LOL! Nice try! You can't help yourselves. That pretty much is your nature. Your presence on here is about deception and the manipulation of others. Investors you ain't! Stay thirsty though!

What is the timeframe on that "quick" buck you are referring to?

Also, as long as RDGL trades on the OTC, no large Investment Funds will touch it, usually per their own internal guidelines.

Maybe those looking for a "quick buck" should start screaming at MK about uplisting to an Exchange since the current path is too long for their (irrelevant) liking.

Just a thought.

Exactly let's go RDGL soon

There's no "IF" there!

All one needs to do is a search of MedTech companies on the NASD that are still developing their product and ZERO REV$ but whose stock trades in the double figures.

The main reason for this being high institutional/Insider ownership based solely on "potential", thus leaving a minimal float available for trading (manipulation).

Some don't even have ongoing trials anywhere in world, and yet................

You're obviously unaware of this fact!

Well that's a BIG "IF" though

It would be $30 if RFK tweeted about it
It would be $28 if a celebrity gets cured during trials
It would be $50 if someone paid $50 for it 

Yes, about 73 people left. 

Not sure about $24 but RDGL would most definitely be trading at or above $5 on the Nasd.

The OTC hustlers (not Longs) that drive short lived pps runs simply don't have the patience or the foresight, IMO, to hold onto their shares as do the Inst. Investors that populate the Exchanges.

LOL, are there still people out there who believed that ChatGBT isn't a joke?

Lol! yup, even AI makes fun of what "near" means.




RDGL

ChatGPT being sill today

Subject: Radiogel’s Legendary Timeline – A Masterpiece of Precision!


Ah, fellow shareholders, gather ‘round! It’s that time again when we get to marvel at the sheer artistry of “near future” timelines. Who needs rigid deadlines when we can bask in the ambiguity of soon-ish, almost there, and just around the corner?


Rest assured, the masters of expectation management have spoken: the IDE submission remains on track! (A track that, much like a scenic train ride, has plenty of unexpected detours, breathtaking views of delays, and an occasional missing bridge.)


What’s next, you ask? Well, updates will flow as information becomes available—which, judging by past patterns, is as predictable as a meteor shower. Stay tuned, stay hopeful, and above all, stay patient. After all, precision is overrated when you can simply embrace the mystery of the near future!

I've been excited for over 6 years many times before.

Glad someone on the board is getting excited.

Now if a few more people get "excited" maybe they could get RDGL moving back UP again! 😁

Maybe ASAP would be more acceptable to some on the board?? 😁

According to Google near future is "at a time that is not far away". Hope this helps.

Let's break out 0.25 first before IDE resubmission in next month.

I would guess "near future" means within a month or so... could really get interesting with the IDE submission and results from India start rolling in in the next few weeks.

Sure

George Sharp has said:

If RDGL was trading on the Nasdaq now, it would be trading at least 200x current share price.

That would be $24.00+ per share.

Could be IDE submission before end of March.

And IDE “approval” sometime in April.

Excellent ….

I was a little disappointed with the update last week, on the potential “perceptual” timeline delay, but now getting excited again.

Been a shareholder for 7 years here.
Don’t want to have to wait another 7 years, lol.

Lol IMO SOON ENOUGH

Ok, let's beat the hell out of the definition of "near".

I'll go first. Soon? 😁




RDGL

Update on the IDE Submission Date

February 25, 2025

Following the conclusion of our Sprint process with the FDA last week, we are actively compiling additional safety and efficacy data from our ongoing human clinical trials in India to support our upcoming IDE submission. Importantly, completion of the Phase Il clinical trial is NOT a prerequisite for this process.

While we have been mindful not to provide an inaccurate submission timeline, we want to reassure our shareholders that we remain on track to submit our next IDE application in the near future. We will provide further updates as more information becomes available.

Volume should increase in the near future. 

https://x.com/radiogel/status/1894421810638422446?s=46&t=MxR4z7pPou_0usGfqAHGvQ

Bam baby!
https://x.com/radiogel/status/1894421810638422446?s=46&t=BhTJBtmkPHgCEZtP09Ehxw

Smacking them right on the head lol let's go RDGL

All just my opinion, but I like to link to help DD and ask others to do the same to up the overall education game/discussion.

Form 10Q filed with SEC for Q End dated 09/30/2024

Go to Item 2, scroll down to "Financing and Strategy". Its a good read, imo. 3rd paragraph from the bottom of page 21, specifically, makes a reference to Class 2 vs Class 3 or otherwise FDA approval subject to whatever FDA goes with. This implies to me that Class 2 is on the table for discussion with FDA and I understand we have had our final FDA Sprint meeting.

Radiogel Feb 2025

Again, I just express my opinion here same as everyone else. Does this help you understand my opinion better?
As for my bright future opinion? I am unaware of ANY Class 2 FDA approved Brachytherapy Device in this $30 Billion industry (depending on whether you use 8-11% cancer market share and/or 5-8% CAGR) so while some of the over 3000 Class 3 Brachytherapy devices will always have uses moving forward, a very favorable FDA Class 2 ruling would put our Breakthrough Device Designated product into a market class all its own... with Isopet as a corporate division and future Alpha gel, etc... for additional growth beyond the roughly 16-18 revenue verticals being unlocked potentially in India this year....

Orrrr, maybe I'm wrong n we just all turn the lights out n go home this year, lol, just saying "Time Will Tell"

-Go $RDGL

Why is that called "bithching" Is it not normal to address concerns and express your thoughts?

well you can keep bitching here but it's not going to change the process Vivos is following with the FDA.

good luck

Well written.  It ain't that hard.  They got everything they need and simply can hit send.  It isn't like they are asking for approval post a phase 3 study.  They simply want to start a trial.  Good things come to those that wait.  Come March, the submit button will be hit

My deadline is the following:

None of Chereb19's business.

You were very helpful earlier this morning actually saying and providing things of value. With that said, thank you. However, these last two posts? Rude. You set yourself up for that.

The company has stated that as results emerge, they will be shared by the FDA to support the IDE application. With initial results of the first patients expected by June 30, it is not unreasonable to believe that the application will be submitted in July or earlier.
I expect that the company will announce the approval of the expansion of the subjects to 50 in the near future.

You have the right to have expectations but it doesn't mean the company has to listen. What's your deadline before you sell?

The stock price is declining very likely because an update needs to be given sooner rather than later.

Stop acting like I said I needed an answer as of yesterday at 4pm.

Yes, because I own shares I have the right to have reasonable expectations.

I don't know what any of this means.

When was the last time Vivos mentioned Class II vs Class III devices? You keep mentioning this and I always wondered. I think I heard that mentioned maybe once back in the Advanced Medical Isotope days.

You think that the data from the first five patients will be available in five months?

Where is the revenue from IsoPet? Amazing initiative and we would not be here at the moment without IsoPet and it has incredible potential to be a blockbuster. Where is the revenue though?

What do the budgets for ALL of the three letter agencies outside of the FDA have to do with Vivos?

"the future is so bright"? What PR did you read exactly...........?

Or you can sell your shares an invest in a company that communicates within your expected timelines?

An update needs to be given this week.

Like WhAtEvA1 said, Telix doesn't have pockets deep enough to buy Radiogel. Partners perhaps? Possible.



RDGL

The "sticky wicket" with FDA is still Class II device vs Class III, imho.
FDA Class Examples

I think Vivos claims we are as safe or safer than a simple Cardiac Pacemaker or a Defibrillator (Class II),
but all Brachytherapy devices approved so far are at Class 3 like an infusion pump or implantable pacemaker; likely due to the glass/polyresin/metal beads and/or glue etc used to deliver the radiation dose (which our product DOES NOT use).

As a result, the Cost/Benefit data used by FDA for a new Brachytherapy may arguably not really apply to our product and the Human Trials for safety combined with anecdotal data from Isopet and the successful Rabbit and genotoxicity write ups are essential for identifying more reasonable cost/benefit data.

In other words, we could have had Class 3 approval some time ago, imho, because all the IDE needed data is done but by continuing to press for a Class 2 the FDA response has been to favor more info to prove the Class level upgrade. FDA'S 1st chance to indicate acceptance as Class 2 is possible would be the 30 day post injection Human Clinical Trial preliminary data.

All in my opinion, of course, but by July 1, I think the 1st 5 patients data from our 1st Human Clinical Trial is complete, described, and published in a peer reviewed journal by end of year. This could be true for significantly more than 5 Humans treated.
Feb 2025 PR on IDE Human Trial milestones

If FDA really just needs human safety data before they can approve Human Safety trials as a Class II (truly a cleft stick/ Catch 22), then I think Good data is available now, better data is planned by Fourth of July holiday and the data is literally as good as it gets by end of year.

It looks to me as though whether or not FDA ever approves our product, we are on track to produce revenue all year from Isopet clinics with an International expansion into and across Human treatment populations by year's end. I think the market generally looks 6 months ahead, so June 2025 could see Human Clinical Trial safety results published Phase 1/2 from India that may trigger investor interest.

It looks to me like domestic US 3 letter govt agencies are experiencing some volatility for budget and political reasons that levels out around March 2025 when a new budget plan gets done and it then defines some political decisions moving forward. Since March is next week and some investors might prefer buying low to sell high I think we see a general uptrend in share price over the next 2 months subject to spikes up for good news and dips for bad or neutral news... imho. If all goes well, I would not be surprised to see a repeat of the Winter/Spring 2012 chart regarding market driven share prices for this share structure.

Thoughts, anyone?
I think the future is so bright, I gotta wear shades
-Go $RDGL

Let's hope Doc gives us clarification on this matter. It's highly important at this stage he does and I also believe he will.



RDGL

Thank you for that critical information.

I've just upgraded my holding time for Vivos shares from medium term to longer term.

The prospect of a buyout of Vivos by Telix although just visionary at this point, could well become reality once Radiogel becomes an accepted treatment for solid tumors in the US and perhaps worldwide. imho

From what I was told by someone from Vivos, the India clinical data was not expected by FDA to submit the IDE.  However, because the clinical trials India have started, it was determined that by submitting data from the India trials, it would strengthen the submission, when that happens.  And as there will be no more Sprint meetings, I assuming Vivos wants to make sure they have as strong as application as possible before the final submission.  

We just don't know what the qualifier is for "sufficient clinical data" Vivos feels they need which dictates the timeline. 

Website.

Regarding a separate inquiry in the past, Brad responded to it but only to tell me that Vivos could not answer my question in an email. Eventually I got my answer via a monthly update.