Vivos Inc (QB) (RDGL)

I tend to agree with your assessment.
I'm looking for a HUGE percentage jump on IDE approval from current $.06 level.
Price will likely drop from the peak (from traders selling on the news).
From the next bottom it could move up slowly depending on longer-term INVESTORS.
Remember we had a HUGE number of shares traded from early April to early May (~60M shares from Yahoo historical data).

https://finance.yahoo.com/quote/RDGL/history/?frequency=1wk

Question is how many of those buyers were "short-term" OTC traders and how many were longer-term investors?

IMO after EFS APPROVAL and successful human treatments during that short time period and we move into IDE clinical trials which most know will be successful imo. Moving forward quickly to pma this is going into dollars.
Then we also have profitable ISOPET coming in future with human market approval skies the limit as rdgl moves into a very diverse patient treatment types...

Don't forget INDIA and worldwidemarket....

Let's go ISOPET now and RDGL soon....

I’ll add that I firmly believe there are a lot of individuals and groups out there, many with very deep pockets who want to invest, but only after IDE is approved.  There’s sufficient data and evidence to show RadioGel will be successful in human trials at Mayo and others clinics.  But the IDE is needed to green light the trials.  Post IDE is where next round of heavy investment and trading takes place given high probability of successful human trials and the ROI that will bring. 

Nathanial - I would welcome your thoughts...

That might be a bit low.

There’s plenty of DD on John Smith and what’s been done in regards to setting up this EFS IDE submission for highest odds of approval.  It’s unfortunate the MK factor is holding share price down.  If not for JS, I’d have exited by now, but because of JS and current DD, I’ve accumulated a few more shares.  

I think if we hit .25 cents we will hit over a dollar in 24 months based on all of the behind the scenes work. I think those selling below 50 cents are foolish and their shares will be bought up by serious investors. I agree 35 cents with IDE and India results is very achievable.

Agree John Smith is a major improvement.

Lot depends on how strong the Press Release with any additional catalyst updates. And any additional follow up press releases shortly after.  I’m still thinking spike to $.35-$.50 given the long term anticipation for IDE.  Lots depends too on how heavy selling is into news. 

So if we do get approved for IDE were will we ling PPS wise? I am thinking 14 to 20 cents?

I actually agree with your entire post!!!!!!!!!!!

Pretty much everyone is in the wait for IDE approval mode.  MK didn’t do anyone any favors trying to navigate the IDE process himself for the prior attempts. If this was his first attempt with John Smith leading the team, we’d be at $.35-$.40 right now.  

Average daily volume does not support your thesis but good luck. It worth a shot. (Couldn't resist).

Great summary of EFS IDE approval process.
Anyone wanting to invest here should read this first.
I'll be buying more the rest of this week and next!

Current sentiment among investor communities suggests moderate to high odds of approval for this specific Early Feasibility pathway, citing several key factors:

Stronger Data Package: The submission includes extensive human clinical data from India and outcomes from over 100 IsoPet veterinary treatments, addressing prior safety and efficacy concerns.
Regulatory Expertise: The company engaged Dr. John J. Smith, a senior brachytherapy regulatory expert with prior FDA experience, to guide the submission strategy and address feedback from over 40 FDA reviewers.
Pathway Suitability: Experts indicate that the Early Feasibility IDE is a more appropriate and less risky pathway for the current state of the device compared to previous full IDE attempts, potentially increasing the likelihood of acceptance.
FDA Collaboration: The application was developed through the Breakthrough Device sprint process, allowing for close collaboration with the FDA to align on regulatory expectations.
Despite these positive indicators, FDA approval is not guaranteed, and the review process can be extended if the submission is incomplete or if the FDA requests additional information. Investors are advised to monitor for official FDA communication within the 30-day window following the submission date.

Regulatory Context and Timeline
Vivos Inc. officially submitted its Early Feasibility Investigational Device Exemption (IDE) application for RadioGel® on June 5, 2026. Under FDA regulations for Early Feasibility Studies (EFS), the agency operates on a strict 30-day review clock. Consequently, a decision is statistically probable by July 5, 2026.

The FDA review process for an EFS IDE typically yields one of four outcomes:

Approval: The study may proceed immediately.
Approval with Conditions: Minor deficiencies must be addressed (usually within 45 days) before the study begins.
Disapproval: Significant issues prevent the study, though the sponsor can respond to deficiencies.
Default Approval: If the FDA fails to issue a decision within 30 days, the IDE is automatically deemed approved by statute (21 CFR 812.30(a)).
Given the submission date, the "default approval" mechanism would technically trigger in early July if no communication is received.

FDA Early Feasibility Study IDE review process

Factors Influencing Approval Probability
While no regulatory approval is guaranteed, several specific factors suggest a favorable probability for RDGL:

1. Breakthrough Device Designation RadioGel® holds Breakthrough Device Designation, granted in December 2023. This status prioritizes the review and facilitates more frequent, collaborative interactions with the FDA review team, specifically aiming to expedite development for technologies treating life-threatening conditions.

2. Iterative Review and Expert Engagement The June 2026 submission is the culmination of an iterative process involving:

Feedback Integration: The company has addressed inquiries from over 40 unique FDA reviewers over several years.
Specialized Counsel: Vivos engaged senior regulatory experts with prior FDA experience in brachytherapy (including Dr. John J. Smith) to structure the submission specifically for the assigned review branch.
Pre-Submissions: The company filed specific pre-submissions regarding sterilization (E-Beam) and container closure to resolve technical questions prior to the main IDE filing.
3. Robust Data Package The application leverages a multi-faceted evidence base that addresses prior agency concerns:

Veterinary Safety: Real-world safety data from over 200 IsoPet® veterinary treatments with zero reportable serious adverse events.
International Human Data: Clinical insights from ongoing human trials in India (initiated Dec 2024), providing preliminary human safety and dosing information. Early results show zero Serious Adverse Events (SAEs) and significant tumor reduction (up to 80% in some cases).
Technical Validation: Enhanced data confirming precise delivery and localized retention of the Yttrium-90 hydrogel, validated by PET full-body scans to prove no migration.
Vivos Inc

Strategic Implications
Approval of this EFS IDE would authorize Vivos Inc. to commence early human feasibility studies, likely at the Mayo Clinic, focusing on patients with solid metastatic tumors (initially lymph nodes associated with papillary thyroid cancer) who are not surgical candidates. This step is critical for generating the U.S. clinical data required for eventual Premarket Approval (PMA). The company’s strategy relies on this U.S. data to complement its international efforts and support global commercialization.

Let's go ISOPET now and RDGL soon. . .

Excitement is building up. Many people are excited and some are nervous yet excited. I think approval is in the fridge.
Go RGDL !

It’s an early feasibility, probably still won’t get approved. 

Nobody cares. 

You're lost in the shuffle tell us what you don't mean lol...and the other shenanigans....which one is skat???

Let's go ISOPET now and RDGL soon.. imo

ya ok the sell off continues right before the most important decision
hope i’m wrong but this doesn’t favor an approval

By all means please "tell" us what it means. lol

NUTTIN.... HONEY NUTTIN LOL

LET'S GO ISOPET NOW AND RDGL SOON ENOUGH IMO.....

hmmmm

OK, Carnac... what is it telling you?

Thanks, would be great to know before the holiday weekend!

I’m hoping they announce the next day after notice of approval.  Although if they should get notice July 1 or 2nd, I’m fine with them waiting until July 6 to announce.  I think good chance FDA sends out notice be end of day this Friday given next week is short work week and reviewers likely leaving early for vacation etc. The absolute last day company would have to notify shareholders would be July 10, and if they wait until then, it’s probably not good news.  I’m very confident the IDE will be approved.
GLTA!  Go $RDGL!

I would hope they would announce an approval as soon as possible, not sure why they would wait on that. Any reason Catfish?

Sad, but all so true.

Past history with Vivos is that they wait till the last possible day

About 6 trading days until the IDE decision.
Reminder, Friday, July 3rd, the markets are closed.
Always the possibility that we get the decision even earlier.

Rogers711 - were you the one talking about bitcoin options and looking for a 90K strike price?

300k in volume today… very telling. 

Last I checked that's what this board is for, ya know, discussing stuff related to Vivos. You may find it pointless but many would disagree.

What I was thinking also. No reason why they shouldn't start prepping for trials before the FDA response.

You can be both a trader and an investor at the same time......

I have been and will continue to be.

Thanks for the detailed info.
Probably going to take a significant amount of time to full marketing approval no matter how you look at it.

That's why one needs to decide if they're going to be a trader or an investor in RDGL.
That should be an important factor in any buy or sell decisions one makes. jmho

If the IRB was submitted close to same time as the IDE, with the EFS, patient enrollment could start as early as August with first patient dosing September-October, and initial safety data report soon after the 30 day PET scans. 

Elaborating on the regulatory pathway, an Early Feasibility Study (EFS) Investigational Device Exemption (IDE) approval and corresponding Institutional Review Board (IRB) approval are strictly limited to the specific investigational plan submitted and reviewed. They do not serve as a blanket authorization for subsequent or expanded clinical trials.

Specific Limitations of EFS Approval
An EFS IDE is designed for a limited clinical investigation, typically involving a small number of patients (often fewer than 15) to assess initial safety and proof of concept. The FDA explicitly grants approval for a "specified number of sites and subjects." Once these limits are reached or the study objectives are met, the authorization expires for that specific scope. The EFS pathway allows for flexibility in device design and protocol changes during the study via amendments, but it does not automatically authorize a transition to a larger, definitive study.

Requirement for New or Amended IDE
Moving from an EFS to a broader clinical trial (such as a traditional feasibility study or a pivotal trial) generally requires submitting a new IDE application or a significant IDE supplement.

Protocol Changes: If the subsequent trial involves a different study design, a larger statistically powered sample size, new endpoints, or a different patient population, the sponsor must submit these changes for FDA review.
Device Design Finalization: EFS often involves iterative device changes. A pivotal trial usually requires a finalized device design. If the device used in the next phase differs significantly from the EFS version, new nonclinical (bench/animal) testing data supporting the final design must be included in the new IDE submission.
Regulatory Review: The FDA reviews these submissions to ensure the new phase is scientifically sound and that risks are manageable based on the EFS data. This is a distinct regulatory step from the initial EFS approval.
Independent IRB Oversight
Similarly, IRB approval is study-specific and site-specific.

New Protocol Review: An IRB must review and approve the new protocol, informed consent forms, and investigator brochures for the subsequent trial. They cannot simply extend the EFS approval to a new study phase with different risks or procedures.
Continuing Review vs. New Approval: While IRBs conduct "continuing review" of an ongoing study, transitioning to a new phase (e.g., from feasibility to pivotal) is often treated as a new research activity requiring initial review and approval, not just continuing review. The IRB must determine that the risks in the new, larger trial are minimized and reasonable in relation to the anticipated benefits.
Strategic Transition Pathways
While a direct "move" without further submission is not permitted, sponsors can plan for a smoother transition:

Adaptive Trial Designs: Sponsors can design a single IDE protocol that includes pre-specified phases (e.g., an EFS phase followed immediately by an expanded phase upon meeting certain criteria). In this scenario, the transition might only require an IDE amendment and IRB approval rather than a completely new IDE, provided the overall plan was approved initially.
IDE Supplements: For less drastic changes, such as adding more subjects to the same study design or adding new sites, an IDE supplement can be submitted. The FDA typically responds to supplements within 30 days.
In summary, RDGL cannot bypass the regulatory requirement for a new or amended IDE and fresh IRB approval when transitioning from an EFS to a subsequent clinical trial. The EFS data serves as the foundation for these next-step applications, but it does not replace the need for them.

FDA IDE supplement vs new IDE application requirements

Transitioning from Early Feasibility Study to Pivotal Trial FDA guidance

Based on recent FDA guidance and industry analysis, the answer requires a critical distinction: while you do not necessarily need a brand new IDE application number, you cannot simply "move directly" without further regulatory submission and approval. The transition requires specific FDA and IRB actions to expand the scope.

1. FDA Regulatory Pathway: Supplement vs. New IDE
Contrary to the requirement for a completely new IDE, current FDA guidance (as of 2026) explicitly states that "a new IDE is not needed for transitioning to a pivotal study." Instead, the transition is typically managed through an IDE Supplement.

IDE Supplement: To move from an Early Feasibility Study (EFS) to a pivotal trial, RDGL must submit an IDE supplement containing the EFS results, additional safety data, and the full investigational plan for the pivotal study. The FDA reviews this supplement (typically within 30 days) to approve the expanded protocol.
Same IDE Number: Sponsors can often continue under the same IDE number by submitting a "Protocol Amendment" or supplement, provided there is no significant gap between studies and the transition was anticipated.
Device Design Finalization: A key requirement for this supplement is the completion of nonclinical testing. While EFS allows for iterative design with limited bench data, the pivotal phase requires finalized device design supported by comprehensive bench and animal testing. If the device changed significantly during EFS, this new data must be included in the supplement.
2. IRB Approval Requirements
IRB approval remains a distinct, mandatory hurdle that does not automatically carry over.

New Protocol Review: The IRB must review and approve the new pivotal protocol, which involves different risks, endpoints, and often a larger, more diverse patient population than the EFS.
Informed Consent: New informed consent forms reflecting the pivotal study's specific risks and benefits must be approved.
No Automatic Extension: The initial IRB approval for the EFS is study-specific. It does not authorize the expanded enrollment or different procedures of a pivotal trial without a fresh review and approval of the supplement/amendment.
3. Strategic Efficiency
The EFS program is designed to facilitate this exact transition efficiently:

Parallel Testing: Sponsors can initiate the EFS while completing the additional long-term bench and animal testing required for the pivotal study.
Data Pooling: If planned in advance and agreed upon with the FDA (preferably via a Q-Submission prior to EFS initiation), data from the EFS can sometimes be pooled with pivotal study data, eliminating enrollment gaps.
Continuous Enrollment: Because a new IDE number is not strictly required, sponsors can structure the transition to minimize delays, moving from the last EFS patient to the first pivotal patient seamlessly once the supplement is approved.
In summary, RDGL cannot unilaterally "move directly" into pivotal trials upon EFS completion. However, the pathway is streamlined: instead of a full new IDE application, RDGL submits an IDE supplement with finalized device data and the pivotal protocol, obtains new IRB approval for that protocol, and then proceeds under the existing IDE framework.

FDA IDE supplement submission requirements for pivotal trial transition

1. FDA Requirement: IDE Supplement, Not Automatic Progression
The transition from an Early Feasibility Study (EFS) to a pivotal trial requires submitting an IDE Supplement to the existing IDE. The FDA does not automatically authorize the expansion of patient numbers or change in study phase.

Submission Content: The supplement must include the EFS results, any additional safety data, the full pivotal study protocol, and crucially, completed nonclinical testing (bench and animal) on the finalized device design. EFS approvals often rely on "just-in-time" testing; pivotal trials require the full dataset.
Review Timeline: The FDA typically reviews these supplements within 30 days. Until this supplement is approved, enrolling patients under the pivotal protocol is prohibited.
Same IDE Number: Sponsors can usually continue under the same IDE number via this supplement, avoiding the administrative burden of a brand new application, provided the transition is seamless and justified.
2. Data Pooling Constraints
A common misconception is that EFS data automatically counts toward the pivotal trial total.

Default Stance: The FDA generally considers EFS data as supportive rather than pivotal. It is often not appropriate to pool EFS data with pivotal data for the primary statistical analysis unless specifically planned and agreed upon in advance.
Pre-Planning Required: To pool data, RDGL must have proposed this strategy to the FDA prior to initiating the EFS (ideally via a Q-Submission). Without prior agreement, the pivotal trial usually must enroll a full, new cohort of patients, making the EFS a distinct, preceding phase.
3. Independent IRB Re-Approval
IRB approval is strictly protocol-specific. The approval granted for the small, iterative EFS does not cover the larger, definitive pivotal trial.

New Review Mandatory: The IRB must conduct a new review and approval of the pivotal protocol, updated informed consent forms, and the revised risk/benefit analysis.
Site Activation: Even if the FDA approves the IDE supplement, clinical sites cannot activate for the pivotal phase until the local IRB grants this specific approval.
Summary of Required Steps for RDGL
Finalize Device: Lock the device design based on EFS learnings.
Complete Testing: Finish all bench and animal testing required for the final design.
Submit IDE Supplement: Send the pivotal protocol and full data package to the FDA.
Obtain IRB Approval: Secure new IRB approval for the pivotal phase at each site.
Receive FDA Approval: Wait for the FDA's approval of the supplement (typically 30 days) before enrolling the first pivotal patient.

IMO with Lowell Law medical device expert John Smith in control of the current FDA process he has set this up to be an almost seamless process to fulfill RDGL mission of taking RDGL to market.

And I'm of the opinion it will flow quickly going forward. Having the ducks lined up not to miss a quack in the process.

And we know the science works ie
ISOPET
INDIA

Let's go ISOPET now and RDGL soon...imo

Here's an AI response to my question about the time interval from IDE approval to trials initiation.
Key takeaway:
The FDA’s 30-day approval window is the regulatory hurdle; the actual start of trials is often delayed by IRB and operational factors. Planning for 3–6 months from IDE approval to first subject enrollment is a reasonable expectation, but longer timelines are common in practice

What I would like to see instead of IDE approval dates are some "guesses" on the date of trials initiation.

I have no experience or info on how long it takes from IDE approval to actual start-up of trials.

Any informed guesses would be appreciated! LOL

$1-$2 is quite the appreciation from current level (15x to 30x).
All I can say is good luck with those expectations.

I'm in it for a price appreciation whether it be short or long term. Ideally I want to see $1 - $2 upon IDE approval which hopefully is short term. Or, I see more upside and then I am long term. In the OTC, long term does not often exist.

.

Yup

Why discuss specific dates for approval or otherwise?
I'm sure most folks here realize that these are just individual guesses. But for what purpose?

One thing I can almost "guarantee" you is that no matter when it occurs, there will be some traders selling on the news (positive or negative).
It's just a "normal thing" on the OTC.

If you're in for the long term, the exact date of approval is meaningless imho.

Okay, thanks