Vivos Inc (QB) (RDGL) News

Bahahaha you are funny.

Yeah yeah buddy

Mayo has prepped to do this procedure

Perhaps some of Jimmie come lately s and ones that really haven't been oaying attention do some DD concerning the last 6 to 8 months

I work at a hospital… bureaucracy comes with “we meet once a month” “paper pushers” lol

Actually I doubt it will take much time at all

Considering that Mayo has been an integral asset through the entire submission process . They've had plenty of time to prepare for the IDE approval event

Well, glad I took my own advice and checked out for 11 days. Seems I only missed hair pulling. Wish they had held article till next wed/thur into what I expect to be heavy traffic.
Also irb could take a little time (it's hosp bureaucracy). It is another validation of efficacy though. I should say "when it's signed off on". It's a symbolic vote of confidence. Especially for an outfit as small as this.

Very nice.

Time to move 🚀

300,000 bid .172 etrade

June 29th 2024.....

https://tradersque.com/vivos-inc-announces-ide-submission-for-radiogel/

March 27th 2024.....

https://tradersque.com/vivos-inc-innovation-in-precision-radionuclide-therapy/

RDGL I've been lurking for several weeks now and like what I see.....safe to come back into the water after today's fiasco....

Agreed. Posting is usually a complete waste of time imo. We know what we own in RDGL$. GLTA.

So much for all of our collective price forecasts! Looks like the market won't reward this ticker with higher share price until approval.

I don't like it, but it is what it is.

Other brachytherapy devices uses beads thats been placed next to the tumor.. the danger of that is it travel in the body to other places and can do damage to healthy organs. Another brachytherapies uses catheters or tubes thats been put intra-arterial and dosing the radio isotope straight to the tumor through guiding the tubes/catheter through the blood vessels that’s feeding the tumor and releasing the isotope to the tumor.. very difficult approach. Dangers of this treatment is overdosing, under dosing or damaging the blood vessels or leakage to other organs..

RadioGel distinguishes it self from others because it can be placed by a needle trough the skin or operation and injections straight to the tumor

Excellent manners he has! Very pleasant.

No, he’s one of the best veteran posters on here ….

You’re showing your “newbie” colors here.

And with that, welcome to the board still

We already know where this stands and what needs to be done.

Excellent questions.

Unfortunately I don't have an answer to any of them.

Hopefully someone does.

Nah I'm not flipping out skate
.lmao

🙄 I want it to succeed as much as you do but you are constantly getting angry when someone states the facts. I'm not inventing anything just pasting excerpts from articles approved by the company and FDA website. You're flipping out for no reason.

Or JHU. IRB is very easy to submit. I’m assured all the relevant questions and concerns answered for the FDA application apply.

200k on the bid at 17 cents on e trade

Chumly get lost w the bullshit lollpl

Almost all of us here have been here for a very long time . What's required and how it's going to move forward is already known

So take the newby bullshit and not waste anymore or your time or anyone else's

My thoughts are to wonder how the RDGL device is being treated by the FDA?

In other words Brachytherapy is not some new device... it has a decades long history.
Y90 is not a new radioisotope for cancer treatment... it has a long history as well.

The gel is an original formulation and the Y90 is far more pure than currently approved bead brachytherapy solutions.

Is FDA approving this as a new device? A new formulation for an already approved device? A human safety improvement from category 3 to 2 (more safe) for an existing device use justified by the Breakthrough Device Designation?

The answers could significantly affect/shorten the typical timeline here, no?

Discuss /explain if anyone here is up on all that stuff please?

- Go $RDGL

Mayo is waiting for FDA approval.. They want to start asap !! Vivos has already send the clinic trial protocols to the IRB gatekeepers for comments in anticipation of fda approval.. everything is prepared.. just waiting on fda green light

It is not done yet. https://tradersque.com/vivos-inc-announces-ide-submission-for-radiogel/
Collaboration with Mayo Clinic
In anticipation of FDA approval, Vivos Inc. is collaborating with the Mayo Clinic to prepare the necessary documentation for submission to their Institutional Review Board (IRB). This partnership aims to facilitate the initiation of clinical trials at Mayo Clinic, leveraging their extensive expertise in oncology and clinical research.

Dont listen to lost and lollipop
This information has been posted at nauseum...take your FUD and .

The FUDSTERS are trying like cockroaches

https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-institutional-review-boards-irb

Mayo is waiting for FDA APPROVAL of course you know that or not
MAYO IS READY TO GO
FULL STOP

Mayo clinics IRB has been with Dr Korenko and rdgl throughout this process so we are good to go
Mayo has completed the practice protocol with dummies....
Now we go live ....imo

In that case, I would expect Mayo to assist, as someone else said.

The opposite: Studies of devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study.

That is for a non-significant risk device such as contact lenses. That doesn't apply here imo...anyone else on the board have any thoughts?

That’s through the Mayo Clinic so nothing to worry about there.

The Mayo Clinic has been extremely proactive with Radiogel.

Pretty sure they also need an IRB approval prior to starting trials. https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process

Great information, thank you!

Mammoth! For all the fudsters asking whether the fda got the submission or not. I believe we will be accepted via non response. That sets phase 1 trials to begin as early as 7/30/24 although 8/1/24 for the first patient works too!

Nice article in a website for the medical device industry (versus the many AI generated investor rag articles that have been coming out). Looks to me like they got more meaningful quotes from Korenko.. Apologies if this was already posted. Note it says that funding of startup and early-stage companies through investments made by venture capital firm has increased by about 550% from $63m in 2017 to $408m in 2023. I wouldn't mind a partnership to get some of our funding to stabilize price, but I don't think Korenko will go that route.

https://www.medicaldevice-network.com/news/vivos-eyes-human-trials-for-radiation-treatment-gel-with-ide-submission/

Ahh, this quote below I'm pretty sure I saw posted before that put the recent buyouts of companies like Vivos at a low of $1.4 billion to a high of $4.1 billion. Nice morning reading to remind me to hold my shares!

Big pharma has made plays for the space in the past year too, with Eli Lilly, Novartis and Bristol Myers Squibb signing deals ranging from $1.4bn to $4.1bn to acquire radiopharma specialists.

Been reading about the BDD more this morning. Getting that designation was certainly a boon for the company. Recall the path Vivos anticpates taking is to apply for a De Novo marketing authorization. I cannot find anything about IDE submission of devices that qualify as BDDs. I'm beginning to think that is because that first step is a relative non-issue.

The increase of breakthrough device designations has allowed more products to get to the commercial market in a shorter amount of time. Under the breakthrough device program, the average time for review of a 510(k) clearance decreased by more than 50%, down from 270 days to 155 days. Similarly, the breakthrough device program has decreased time to grant for a De Novo marketing authorization by 68 days, a decrease of more than 25%.

An update from our Vivos Inc. CEO, Dr. Korenko regarding the IDE application. The FDA has acknowledged they have received the application. It is under interactive review. #Cancer #CancerJourney #CancerAwareness @RadioGel @IsoPet $RDGL pic.twitter.com/8uzgmiFlVb— Vivos Inc. (@VivosIncUSA) July 9, 2024

For those with L2 (.... and I'm hoping that's everyone...lol) the Pre-Market action just prior to the open tells the story. ....as in yes, I agree with you this AM

Obviously MMs control the PPS down

MM talk is all BS.. this is just people don’t know what they are holding and getting nervous.. All i can say the approval chances is like 95% thanks to the EFS program.. they did everything the FDA asked for so be prepared for a slingshot to the stratosphere when the news drops..

Obviously MMs control the PPS down

Added 0.168 here.

The production cost is lowered by the years to $ 6000

Did the company say this? I missed that memo. If you computing from a 10-K I don't think we can make that assumption because Vivos does occasionally subsidize the cost of treatment.

Don't get me wrong being closer to $5k than $10 will be a go/no-go switch for more than a few pet owners!

I Just saw double rainbows, which is a great indicator that, it will be a great day today.

Grab them while you can….

And the FUDSTERS forgot to mention the treatment is covered by Pet insurance...they knew this

It's their way of getting people to sell into their FUD

Added 16s in what's wildly moronic stock price and market cap for the company

How paranoid do you have to be to think that there are only three people on the internet? All I did was post an article explaining why the treatment is not as popular. So weird…. But ok

just grabbed 5,000 more at .165
ridiculous

The plan with IsoPet is to get more clinics throughout the US so the travel distance will be considerably shorter.. the issue was people didn’t wanted to travel a long distance with their pets.. And by having more clinics they can increase the animal patients and lower the cost at the same time..

The production cost is lowered by the years to $ 6000

If 2 dogs could be treated with the same production preparation than the cost is about 50% of what would be otherwise, and if you could treat 3 animals ( doesn’t has to be in the same clinic ) at the same time the cost goes way down..

The plan is to schedule multiple animal patients that can be treated at the same time ! Not necessarily in the same clinic but important is the treatment is all on the same day so they can do one production run and separately send them to the different clinics

Relax....MMs need shares and this is how they get them. Should close in the green today and the rest of the week.

It's definitely cheaper now than it was 5 years ago.