Vivos Inc (QB) (RDGL) Quote

Isn't the Radiogel™ Precision Radionuclide Therapy device a Class III Medical Device.

"The cost of clinical trials for medical devices can vary greatly depending on several factors, but estimates range from $6 million to $94 million.

Complexity

The complexity of the device and the regulatory pathway chosen can impact the cost. For example, a Class II medical device of medium complexity can cost between $2 and $5 million for research and development, and around $30 million for FDA approval."

There isn't anything on Clinicaltrials.gov about the Vivos medical advice.

From the 2014 10-K:

"Throughout 2014, the Company focused on the development of its brachytherapy products including the regulatory review of the Y-90 RadioGel™ device by the Food and Drug Administration (“FDA”)."

They have been pumping this for 10 years and still years away from generating any revenue.

IG

Zippy is doing amazing! Treatment worked exactly as it was supposed to. He's a very old horse and his breed/color is very well known for cancer problems. It was on his upper tail and it eventually bursted prior to the treatment. He was rubbing it on the walls and a bad infection resulted from it. Smelled horribbbbble. After they cleaned it up and did the treatment it was all clean, fast, and effective. You would never know it had happened.


The place is somewhat active on their facebook. This is a small family run volunteer nonprofit barn to help people with disabilities. They are still running business as normal. They're not exactly tech savvy people lol. They heavily rely on the volunteers. They make a little money from boarding horses and the "lessons" they give to clients on riding. Most clients are people with disabilities like physical or mental who gain balance or just basic physical activity.

Tough business as horse people are slowly fading away and insurance companies aren't covering thay type of therpy as much as they used to. At least here in southern Maine. All the farm land is turning into houses lol.

Another day passed is another step closer to IDE approval 🙏🤞

I have a friend who is also just waiting for a price to jump in. I just told him about the stock, didn't recommend him to buy as my track record of investments is all over the place. This SHOULD be my big winner....

Don't be surprised if the FDA doesn't respond in any way. That is good news as after 30 days with no response from FDA, the application is then considered approved.

Well written and the company will likely move to the Nasdaq some time after phase 1 trials so institutional investors will gobble this up

If fishy...I would initially lay blame on the FDA (if we don't get FULL approval for IDE) but would be interested to hear what RDGL has to say about it.

Very unusual to see “calm before storm” when pending FDA news. Normally it’s the other way around. This can be something YUGE or something FISHY.

The calm before the storm. I am betting all of my 320k shares that once we get IDE approval from FDA this will 💣💥.

Of course, I could be wrong, and the market will not reward longs with the share price we all believe we should have after approval.

Time will tell. 🤞

🤖🤒😵‍💫

Spoke with my brother in law today,he's exited about Radiogel and will also be buying in. I wasn't liking the the low price either but this will help him get in before this heads way north.GLTA

I agree Big Al T. With BDD and EFS, they could start and complete Phase 1 in just a few months, by end of Q4, depending on how quickly Mayo gets the required patients.

Yep, could be a "blessing in disguise" soon for people who didn't sell at submission news. When trial protocol is finally announced and folks see how short ph1 duration is, their horizon and outlook will most likely change as well.

LOL, what a phony! As if you're disappointed, right? The manipulation season is nearing a close and some people on here will have no air to preach passive aggressive toxic positivity any more.

More like "depressing"...

"Second, once FDA grants IDE approval, and start of phase 1 for the thyroid trials is announced, I expect market will react very favorably and strongly as radiogel as already been proven very successful and safe with pets".

Consequential paradigm shift is what will happen post FDA IDE clearance. Market sentiments will improve significantly IMO.

Very very interesting price action, volume, silence, while being sooo close to finding out the destiny of the company.

Exactly and remember BDD from FDA is the catapult imo to obtain IDE APPROVAL and marketing the product without a fishbowl

For all the Karens bagging on Isopet as a waste of time and money, without Isopet, Vivos would not be at this point now waiting on IDE approval. All that testing and patient data from Isopet was used for the IDE submission.

Second, once FDA grants IDE approval, and start of phase 1 for the thyroid trials is announced, I expect market will react very favorably and strongly as radiogel as already been proven very successful and safe with pets. The initial human trials should go quickly and smoothly.

I’m taking it as a positive.

Someone needs to get a job. Too much time on their hands with irrelevant & pointless posts that are always obvious & self serving.

Someone implied I was worried about the 60ish comments, I'm not. I have never mentioned them. Vivos has addressed all questions and even repeated some tests that the FDA didn't ask them to (Korenko knows from past experience that more tests can pop up at any moment) and cleaned up all documentation and websites in anticipation of what could be commented on. Again going above and beyond what FDA asked/mentioned. Korenko has doing everything within his power to have this submission address all possible issues. I think the genotoxity was a complete curve ball thrown at them. They have a lot of experts (vets, radiation specialists, FDA consultants, etc) and it is obvious Korenko said consider everything the FDA could bring up at this point and lets address it before submission. Now we have to wait and see if team Vivos was succcessful with that brainstorming or the FDA has another surprise up their sleeve. If they do it will be an out of the blue like the genotoxity BS.

weak again...you must try harder

I think I recall you were at the treatment of Zippy the therapy horse? Been meaning to ask for a long time how he was doing. I figure no news (from you or Vivos) is bad news, but I hope I am wrong. I dug up my tax receipt (from the donation) and it looks like the riding center isn't in business anymore. At least no social media updates in over a year. If so that would be a bummer too.

Agreed. It appears ALL SYSTEMS ARE GO as I stated in my last post. RDGL$.

from submission PR: “We are appreciative of the improved communication with the FDA since receiving the breakthrough designation”

some here need to relax about any newer FDA reviewers not being clear on a few things, they’ve been in the loop, Vivos addressed it all

NO NEWS IS GOOD NEWS IN THIS INSTANCE

And I would be hard pressed to believe that the likes of MAYO and others would be heavily involved if there really were any serious questions as to the drugs efficacy . Every day that goes by with no news increases the chances of it being approved exponentially

ALL imho

I agree with this completely.

Might be construed as a positive that we have not heard anything from the FDA or company yet with regard to additional information being required.

No fish bowl ??? LMAO
Because if 3 cats were there....lol

This board is becoming bored with lack of patients lol...but we will be treating outpatients soon enough imo
Get on board slackers

Hope we get the response soon

Will we run out the clock or will FDA give a response before 30 days .Think we have less then 14 days left.what would be better for $$$$$

Totally agree on all points

Agreed MC73.

I don't think there will be a big sell off after approval. I think a lot of old longs are trapped waiting for approval. Many, myself included wanted to unload some on a IDE Submittal pop. Now that I am forced to hold and wait for approval, there is no way I sell after approval. Upon approval we will be waiting for Phase 1 results. I am 99.9999% positive of positive results. IDE Approval is the only road block in front of us at this time imo.

I dug up the Instagram 'reel' and was able to watch that w/o having to get an instagram account.
https://www.instagram.com/isopet.cancer.therapy/reels/
The video shows the marketing lady (I think the other two are mostly support and she would need help setting up, tearing down, and keeping the booth supplied) working hard and engaging with attendees. I haven't changed my mind about the fact having someone there who had used the product there would be advantageous, but she was definitely engaging with others about the product and working hard. I didn't see a fish bowl for a give away, so the video of someone writing down information while the marketing lady waited could have been for followup from the company about becoming a clinic. Having the peltier chiller on hand to hold and use as a visual aid is great and she made use of that.

Based on this video, my comment in my earlier post that "If IsoPet is at the point of being able to attract new clinics by having three ladies pass out brochures that is fabulous. But I don't think we are." looks to be wrong. It does appear that the existing marketing can be successfully done w/o a scientist of veterinarian who has used it on hand. The display, the demonstration chiller, and yes, even the Dachshund (Finnegan?) was puling the attendees to the booth. No tee-shirts needed. Just candy and brochures/pamphlets and a enticing product on easy to digest posters. I still think that if a vet that had used the product wanted to go to a conference that it would be worth the companies money to send them in return for two hours a day at the booth to talk to other vets.

I definitely don't want anyone from Vivos at a conference now. They need to be focused on being available to and responding to the FDA.

I'm glad someone else is being proactive! 😂

You’re not the only one, well maybe you’re the only one on twits, but there’s several others reaching out beyond IHUB and stocktwits

I’m not sure if you’re reading that right, but when I read roof’s post to yours I could clearly tell he was insinuating that you have only been to parent teacher conferences not med/science conferences. It was definitely sarcasm and nothing was disparaging towards teachers or students in that post, other than letting you participate in the conference. Jk

Yet, I'm the only one shamelessly pumping it on other message boards.

Yes and that theory is very obvious...it will be like a herd of stampeding Buffalo when the gate opens...

I like your theory on that ….

And that could very well be true, once they get approval on humans.
It makes a lot of sense.

"Probably not the most likely but not zero either" You and ASCM seem to basing your skepticism, that the FDA will punt this go round, on the number of items (63) the FDA requested further clarity on. But more so because of this one paragraph from the Jun 28th press release announcing application submission.....I won't ridicule you for that. But I do take exception to your deceptive style of posting. Some of which we have witnessed again here today. I've said this before and I'll say it again. Very odd behavior for someone who claims to be long here....your living proof rock bottom still has a basement.....


Dr. Korenko stated, “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly.”




Vivos Inc. Submits the Application to the FDA for Authority to Initiate Human Clinical Trials

Richland WA, June 28, 2024 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. filed the application for an Investigational Device Exemption (“IDE”).

The filing was an amendment, addressing the FDA comments to our previous application (Q211938/S001). Today’s IDE submission marks our first filing with the FDA following the grant of the FDA Breakthrough Device Designation for the Radiogel™ Precision Radionuclide Therapy. We are appreciative of the improved communication with the FDA since receiving the breakthrough designation. Our IDE filing contained reports on two complex studies, RadioGel® genotoxicity and the retention of RadioGel® at the injection site in VX2 tumors in rabbits. This current IDE submission addressed the 63 FDA comments received in previous FDA correspondences. In some cases, we repeated underlying testing to strengthen our answers with current data. Dr. Korenko stated, “We are mindful that most of the twelve FDA reviewers have joined in the past two years and we anticipate they will have some comments after reviewing the extensive material in our filing, which we are prepared to address promptly.

In closing Dr. Korenko stated, “We are eager to secure the FDA’s IDE approval so that we can submit our plan to the Mayo Clinic's Independent Review Board (IRB) for clearance to initiate the first in human clinical trials. This is an exciting time for Vivos and we are committed to bringing a new treatment option to patients in the fight against challenging cancer types. Initially our collaboration with Mayo will be targeting solid metastatic tumors in lymph nodes associated with papillary thyroid cancer.

Dr. Michael Korenko
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
Email: MKorenko@RadioGel.com

Follow Vivos Inc @VivosIncUSA, Radiogel® and Isopet® on X (Twitter):

well done

I think many eyes are on this and also all of those eyes have seen prior submittal(s) get rejected. I betting as soon as we have approval the flood gates open. 🤞

if enough people know about it ….

we should for sure surpass that.
Maybe not in the first 24 hours, but eventually soon after.

We need people to know.
in due time for sure they will.
But hopefully people find out about it sooner.

Is anyone still thinking we hit $1 after IDE approval?

TRUTHSOCIAL
I agree 100%
MY OWN DR is one of those
I saw him about 2 months ago shortly after the 59 page report on deaths and injuries from the vax was posted by the CDC, He asked if I had gotten the jab yet, I TOLD HIM NO as I have said since they came out, with that I asked if he has read the 59 page report from the CDC about subsequent deaths and injuries, his comment was "" WELL I HAVEN'T read it ALL YET!".
I looked at him and said DOC you disappoint me very much and he h said WHY, my response was YOU'VE NOT READ ONE SINGLE PAGE OF IT as it was all REDACTED and BLACK OUT so you could read nothing, you should have seen the look on his face

I like to add more shares before IDE approval, not after when PPS will be too expensive. Now just waiting for cash.

Exactly. We'll never become a meme stock 😭

Their web guy needs to update the red banner on their webpage from
"We are on track for IDE Submission to use RadioGel® in human clinical trials."
to
"We have submitted our IDE to use RadioGel® in human clinical trials."