Vivos Inc (QB) (RDGL) News

Be surprised of how many IDIOTS are left to vote those idiots right back in

The idiot is gone with the rest of them ....a few left but not much longer...

Sure hope there’s enough genuine human beings on Biden’s FDA panel that favor helping mankind and doing the right thing over taking a payout. We’ll know soon enough.

💯

Pretty simple. Longs are holding for IDE approval as earlier anticipated runs did not materialize as hoped. So longs are having to hold full positions to realize any significant gains. Days/swings have exited this play already so any recent selling is a few needing some short term cash or closing out entirely not caring that the % for approval is much higher than usual.

Unfortunately, prior history enters into the equation so new buyers are reluctant to enter now on what may be perceived as an all or nothing bet without doing any actual DD to know, again that IDE approval is very likely, 95%+. They would rather wait and ride a sure thing after approval.

Also, this is the OTC. MMs control the action. Uplisting to major exchange can’t happen soon enough imo.

IDE approval is a clean slate and whole new ball game. That’s when we start getting the runs we all wanted earlier. GLTA.

Catfish

Why do people even worry about day to day here? Just buy a stack and wait for the news. If it drops enough. Buy more. Pretty simple :)

I agree with Three2001. WTF is up with these flippers? Stupid time to sell, thats all I know. On the cusp of greatness here, and I ain’t selling one share until the true potential is realized.

Waited all weekend, thinking we were going to start the week off nicely. Waited the whole day, expecting buying at eod. Instead, we get some fking bozo placing a market sell and fking the whole day up. Give us that news NOW. Make this moron regret this sale today. Very disheartening. I know, I know, approval by Sunday. If not during the week, I don't even want to think what other morons might show up.

$RDGL

Not long now ....4 days or less imo ...

No shit... held up all day just to get lod now.... bs. We need a good buy just to get back where we were

Well, this action is total BS.

BUY BUY BUY!

$RDGL

Long time ago https://www.benzinga.com/partner/biotech/24/07/39574547/vivos-one-step-closer-to-transforming-cancer-treatment-with-fda-application-to-start-human-trials

yeppers 4

Did the Benzinga article come out yet?

It only has 14M shares that makes a big difference. Still nice to see it run.

Can you name 10?

I'm expecting a Friday or Monday update or both

Great things coming soon enough imo...

Let's go in a few days or less

Many biotechs run up at least 10x ….

On news of FDA approval.

Big move based on pre-clinical test results. Does that mean it was done during animal test studies or some other form?

Thanks for the heads up.

Nice 500% MIRA move on lesser news than what could come soon here. Bring on the biotech runs.

👍

Per SEC, company has 4 business days to disclose a material event.

They would want to tell the world ASAP if they got approved. Also, SEC rules state they must inform shareholders of a material event.

Think it is Sunday 30 days ..( could they have the FDA response, already and be sitting on it ) fingers crossed hope we get good news

Hopefully volume starts to kick in this week. Getting very close to the 30 day window.

AGREED. NOT near ROI would be if no RS.

I seriously doubt kerenko wrote up what he did in reference to fda acknowledgement of being in recept of the application on the same day he received it. Lolol

This guy doesn't exactly rush to the typewriter to communicate
That we know .

Yep, I agree, as I posted yesterday (below) the importance of the BDD…

This ticker has obviously been GOLDEN before & since the breakthrough device designation last feb.
Just look north of this post to revisit BDD pasted >>that’s the direction we are headed.
3 wks.down 1 to go.

Next week will rock.

The power of a BDD
Credit: chereb19


NEWS --December 20, 2023 Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation (BDD)
https://www.otcmarkets.com/stock/RDGL/news/Radiogel-Precision-Radionuclide-Therapy-Receives-FDA-Breakthrough-Device-Designation?id=425373



chereb19 Re: None
Thursday, February 22, 2024 10:59:59 AM

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173899170

The power of a BDD

Firstly, the BDD fast-tracks RadioGel's journey to market. The FDA prioritizes review for these devices, meaning closer interactions, quicker feedback, and potentially a significantly reduced path to market. This is crucial for RadioGel, as it promises a minimally invasive and potentially curative treatment for difficult-to-reach or radiation-resistant tumors.

Beyond speed, the BDD grants RadioGel access to dedicated FDA experts. This fosters open communication, clearer expectations, and streamlined development. Imagine navigating the regulatory process with a roadmap in hand – that's what the BDD offers. This collaborative approach minimizes uncertainties and saves precious resources, propelling RadioGel closer to patients who need it most.

The BDD also acts as a powerful magnet for investors and payers. It's a stamp of approval, highlighting RadioGel's potential to revolutionize cancer treatment. This can facilitate funding and open doors to earlier reimbursement discussions, ensuring wider patient access to this potentially life-saving technology.

Finally, the BDD distinguishes RadioGel in the crowded medical device landscape. It proclaims it as cutting-edge, innovative, and potentially transformative. This market differentiation is invaluable, giving RadioGel a crucial edge in attracting investment, collaborators, and, most importantly, patients who stand to benefit from its unique approach.

In conclusion, RadioGel's BDD is not just a recognition of its potential; it's a powerful engine propelling it towards making a real difference in the lives of cancer patients. The faster development, closer collaboration, and enhanced visibility it brings pave the way for a future where RadioGel's minimally invasive, targeted therapy becomes a beacon of hope for those battling some of the toughest cancers.

Remember, this is just the beginning of RadioGel's journey. With the BDD wind in its sails, it's poised to make waves in the cancer treatment landscape, offering new hope and potentially brighter tomorrows for patients worldwide.



https://www.otcmarkets.com/stock/RDGL/news/Radiogel-Precision-Radionuclide-Therapy-Receives-FDA-Breakthrough-Device-Designation?id=425373

NEWS -- Radiogel™ Precision Radionuclide Therapy™ Receives FDA Breakthrough Device Designation


Richland WA, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc is pleased to announce that the Food and Drug Administration has granted RadioGel Precision Radionuclide Therapy the designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program.

Dr. Mike Korenko stated “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness. We are currently working closely with Mayo Clinic for our initial indication for use of Radiogel for delivering “therapeutic radiation to solid metastatic tumors in lymph nodes associated with papillary thyroid cancer, accessible by percutaneous direct needle injection, in patients who are not surgical candidates or have declined surgery, had non-radioiodine avid disease and had limited burden regional nodal disease.” The Breakthrough Device classification will enhance the schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.

The FDA’s Breakthrough Devices program facilitates accelerated development and expedites the review of breakthrough technologies to help patients potentially gain timely access to technologies that can provide more effective treatment options.

Contact for journalists:
Mike Korenko
Email: mailto://MKorenko@RadioGel.com

Understanding the IDE Submission Process and FDA Review Timeline

This IDE filing addressed 63 FDA comments from previous correspondences, including reports on two complex studies: RadioGel® genotoxicity and the retention of RadioGel® at the injection site in VX2 tumors in rabbits.

The Investigational Device Exemption (IDE) submission is a crucial step in gaining FDA approval to conduct human clinical trials for new medical devices. When a company submits an IDE application, it includes detailed reports, studies, and data demonstrating the device’s safety and efficacy. Once the application is submitted, https://radiogel.com/ide-submission the FDA has a 30-day review period to evaluate the information provided. During this time, the FDA can respond with one of three possible outcomes

Approval: Full authorization to proceed with the clinical trials.
Approval with Conditions: Authorization to proceed with specific conditions or modifications required.
Disapproval: Denial of the application, requiring further data or changes.

I want to point out that this not only makes practicing doctors more aware of Vivo's radiogel technology but will also get the attention of any company looking to expand or get into the brachytherapy products and services market. This is valuable recognition that cost Vivos nothing.

New journal article published July 1 citing Vivo's rabbit test from 2019.
https://link.springer.com/article/10.1186/s12951-024-02547-9

This is a fabulous paper summarizing use of hydrogels in the treatment of liver cancer in the Journal of Nanobiotechnology. This journal has an Impact Factor of 10.2!!, very high. A high impact factor translators to more readers and more acceptance by the medical community. The rating is called 'impact' factor for a reason.
An impact factor of 10 can be considered excellent – although unreachable in many categories – as in 2020 only 3.65% of the journals had an impact factor of 10 or higher.
The paper has a section on radiotherapy that describes 3 hydrogels that have radioactive particles. Its going to be hard for the medical community to ignore radiogel when such highly read/revered journal's keep describing it as safe and effective.

Here is section on radiogel from the paper.
90Y (Yttrium-90) is a radionuclide that can achieve localized, continuous, low-dose radiation by emitting ß-rays without causing significant radiation damage to surrounding normal tissue cells [117]. The treatment can achieve precise therapeutic effects against tumors, especially for the treatment of primary liver cancer, colorectal cancer liver metastases, and other liver tumors [118]. Fisher created an injectable hydrogel called 90Y-RadioGelTM that contained insoluble, microscopic yttrium-phosphate particles carried by a sterile solution [119]. After the polymer solution was injected into a rabbit with a VX2 liver tumor, the solution solidified at a temperature close to body temperature (30–37 °C). Therefore, the therapeutic agent containing 90Y could lodge at the tumor site and deliver localized, precise ß radiation. Liquid scintillation counting and microCT showed that the radiation from 90Y was contained in the tumor and tumor margins. Therefore, neighboring normal organs or tissues receive a modest dose of radiation dosage, or even a negligible dose. In conclusion, 90Y-RadioGel™ is a radiologically safe and effective therapy option for solid tumors.

The wording seems more like the FDA will let you know what the official date is. Kind of like if you send something to a court it is not official until the clerk stamps it.


Upon receipt of an IDE application, sponsors are notified via email of the date that FDA received the original application and the IDE number assigned. An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved.

Exactly how I read and see it

I just sent a query to Vivos, they always respond, it’s the weekend so maybe I’ll have the answer on Monday, but July 29, first trading day post June 28 submission date 30 day window, is the logical approval by default (silence from FDA) day

Submission was June 28th.
FDA im sure knew rdgl was submitting on this date because they have been communicating on an on going basis. So the receipt of submission would be June 28th receipt June 28th. Doesn't matter when FDA opened the email. IMO Facts indicate 30 day period expires July 28th period.
So July 29th would be automatic approval. board is sounding more and more like the conspiracy theory about rdgl and fda ide approval fkn crazy ...
Guessing Guessing Guessing instead of reading the facts ...
One week or less to go FACTS
For automatic approval

Anytime between now and August 8 at the very latest.

Arguing on all day on Ihub who's right is probably more entertaining and keeps minds occupied while we all wait. lololsss

Why doesn't someone who communicate s with the company just simply ask when the 30 day click began

Based on the text for the IDE process he could actually be right since the 30 day period commences from the date the FDA acknowledges receipt of the submission as opposed to when Vivos submitted it.

Did Vivos indicate what date the FDA verified receipt of the submission?

This however does not preclude the fact that the FDA/IRB could give the go ahead prior to the 30 day "no response" approval.



FDA Action on IDE Applications
Approval or Disapproval §812.30

FDA will notify the sponsor via email of the date it receives an IDE application. FDA may approve, approve with modification, or disapprove an IDE application. FDA may request additional information about an investigation. The sponsor may provide the requested information or the sponsor may treat such a request as a disapproval of the application and request a hearing in accordance with 21 CFR 16. The clinical investigation may begin after FDA and the IRB approves an IDE for the investigation. An investigation may begin 30 days after FDA receives the IDE application for the investigation of a device if IRB approval has been obtained unless FDA notifies the sponsor that the investigation may not begin.

Because the company didn’t confirm a date I don’t think we could be 100% sure that’s it. I think when they submit, they have to log into a portal, and maybe the 30 days doesn’t start until the reviewer logs in and acknowledges everything was received. I’m guessing it will be around July 31 or August 1

Once a tenor , always a tenor. FUD

We've been through this shit before. It is July 29. Stop posting that scenario. Just trying to create doubt, are you?
Or didn't like the answers that you got last time.

I looked and it could be 07 August as on 07 July RadioGel told investors the FDA had acknowledged receipt of the application.

Either the clock started on 28 June and approval come on 28 July or FDA acknowledgement email received on 07 July and approval on 07 Aug. Either way...not too many days of anticipation left.

The date is 7/29/24 and that date has not changed. Can it? Yes. Will it? Maybe, but doubtful. Mayo Clinic is ready

Ok board, I am pasting the guidance from the FDA. One could interpret these sentences to mean the 30 day clock starts when the FDA emails the applicant to conform receipt. If that is how it goes down, the approval dare will be early August, forgot the exact date. Honestly I hope we go without hearing from them as I believe if they do reach out b4 30 days it will be to ask questions

This ticker has obviously been GOLDEN before & since the breakthrough device designation last feb.
Just look north of this post to revisit BDD pasted >>that’s the direction we are headed.
3 wks.down 1 to go.

If we could fast forward to this time next week, and assuming the word remains mum, any ideas on price? You may be right about equilibrium

Definitely lower than I thought we’d be with about a week left, but I guess we are at the equilibrium of those who are already in, and those who are waiting for approval. I feel very confident the application will be approved, or at worst it will be approved with modifications. Let’s go RDGL!

Close on green Friday, not bad for next week run.