Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
As much as I'd like to see that.... I have a hard time justifying $1B-2B just on IDE approval. Even on FOMO hype.
I wouldn't say no to it though!
He's just like smoke in the wind. Follows whatever direction the wind is blowing 🤡
I get where you come from based on the OTC and people who are a little over hyped.
Some of the bigger selling factors to me were that they worked with many universities and in the later years Johns Hopkins vet division.
Probably the 2nd biggest factor to me was that the Mayo Clinic is doing their human trials and gave special permission for their doctor to work with the company, which is against their strict policy of their doctors working with for profit companies.
Lastly and more importantly, the FDA granting the big mean Break Through Device Designation. After working through the Early Feasibility Study program at the FDA's recommendation, they answered all questions, comments and did any test requested by the FDA. Clearly the data that was done at FDA's standards by independent reviewers was good enough for the BDD.
Obviously seeing the product work in real time on animals was a reassuring thing as well. I saw it with my own eyes both treatment and healing progress on a horse. I know that's not important as it doesn't get FDA approval, but damn it's real and not just on paper.
I wanted to doubt this was real myself, but this might be one of the few OTC companies to escape the hell hole market and see daylight one day. Very promising future.
This 100%. 2 years from herre could make a 10x from here look like a joke.
So
Much
Potential
A lot more going on that we don't know about. Both human and animal treatments and uses. Both cancer and non cancer.
Shit will get real quick.
Sometimes it's best not to ask questions... lol
They're also planning on non cancer related treatments for humans and animals.
One thing I think that has been forgotten by many is their mention of the possibility use of Radiogel after surgically removing a tumor.
They would inject the area afterwards to kill any dirty margin (left over/missed) cancer cells.
Imagine the importance of this and the use of the 10,000s of surgeries a year.
Shit could get crazy quick relative to the FDA approval time frame.
How's Ivan?
I would think this is where the Mayo Clinic comes in clutch.
THANK YOU FOR YOUR SERVICE
Dude you post this every 10Q and 10K. It's in all of them. They have to put that in there to cover themselves.
Unbelievable.
To my understanding, the FDA doesn't list a company until they get full FDA approval for market.
To anyone who questions why the FDA hasn't announced the BDD granted to Vivos, please read the following off the FDA's website:
I could go for .04s again so I could get another 500k shares to round me off to a couple mil. Would be worth another 6 month wait lol
lmao love your banner on the posts especially knowing your job.
Might be reaching out to you one day haha.
Makes me think they have other things up their sleeves that they haven't talked about yet.
No and they wont give a estimate due to unexpected events. Last time they gave a estimate they changed their game plan due to the FDA's recommendation on the EFS program and everyone used it against them.
I appreciate VCA's old ticker symbol "WOOF"
This is big news for our company and we anticipate an exciting 2024! More people means more work can be done to grow the company! Monthly update for January will be posted tomorrow but today help us welcome Brad and LeeAnna to Team Vivos! #teamvivos #isopet #radiogel $RDGL pic.twitter.com/kBimtRj2Sb
— Vivos Inc. (@VivosIncUSA) February 2, 2024
Most likely after the market closes due to them trying to avoid day traders. They have been adjusting updates to fight them. Also Saturday and Sunday is viewed as part of the week to most. This isn't business hours Monday through Friday 9-5 lol
Very grateful for this. They've done an amazing job considering the position they were 5 years ago. Debt free is amazing.
Correct. They wouldn't be doing all this for no reason. EFS was positive, but the BDD is what sealed the deal. Very exciting times and can't wait to hear the updates.
On a side note about how quiet it is, Cam Bond did most if not all social media postings. He would share relevant things. He would custom make things like visuals and what not.
I don't see his wife doing the same to the extent he did. I think for now we can expect the quarterly updates and maybe some updates and or PRs, but just not like it use to be.
If I had to take a guess, the FDA reused the original submission. The only reason why they were denied was due to lack of historical data or whatever. Basically lack of recognized testing. That was taken care of with the EFS program.
The EFS program could of also lead them into the BDD. Again these are complete guesses.
Nothing is and will be a fix all cure. There is no one size fit all. A lot of hype over the ADC right now, but there isn't any major changes right now. I believe we will see major changes from Radiogel/Isopet before we see major changes in ADC.
Pfizer's CEO said it himself, they bought the recent ADC to boost confidence in shareholders. Not because there was some serious break through. Again hype right now. They have their time and place just like Radiogel will.
The most important thing people need to understand is that Radiogel will be best fit for some things, but not all. It only takes one or two before the $$ adds up fast though. The one thing people need to understand is that Radiogel can be used for many different things that current treatments and drugs can't do safely and effectively based on the current data. I personally wouldn't sell all my shares after the first indication cause there will be more coming fast relative to the drug market.
I just can't imagine the FDA would grant a company the BDD after going through the EFS to not give them IDE approval unless there was fraud or something absolutely out of left field lmao.
The past 3 years has changed the risk to reward ratio dramatically. Like you said, it's still a very high risk high reward kind of play. When I first got in there was little to no communication, but they have changed that. Seeing Isopet expand and being accepted and used privately and for the FDA requested data at Johns Hopkins has really helped ease my mind. When the Mayo Clinic agreed to do the clinical trails and having the Mayo Clinic doctor working with the company officially REALLY made me confident.
Now seeing the company go through the EFS program after the BDD submission and now being granted the BDD.... well now those FUD voices in the back of my head have disappeared.
They're already looking into other uses for non-cancer related treatments for both humans and animals. Also in the future, they'll be doing tests on mice for future indications like lung cancer. I believe their plan is to get approved for at least one or two indications, then apply for a broad use kind of approval that will cover a ton of things. With the recent news, I think this is very possible especially if the coming human trials go smoothly.
Very interested to see if the new equipment will be licensed to other companies. I think there's a lot more going on that isn't being shared yet. When things start rolling.... watch out lol.
Nothing in this world is guaranteed though.
They stated they only raise money when needed for something.... Looks like they're getting ready for something. Rare occasion to be excited for shares being sold.
Glad to hear he started to accumulate shares again. He knows where this is heading. He has a ton of shares of years ago.
I agree this is way undervalued with everything we have now. I'm assuming due to us being in the OTC market where it's mostly day traders that go off of news and technicals, you're right to say once it's fully realized with a PR announcement stating IDE approval we or submission, we will stay undervalued.
It shows you what a different market we're in compared to the first BDD submission. Didn't we hit almost 0.3? Now with BDD approval we maybe hit 0.08 with like 1/10th of the volume. Crazy.
I'm going to be selfish and be okay with this situation so I can grab as much as I can. lol
Ticking time bomb, but you can't see the timer.
I try not to come off as a pumper, but I agree 100% that you will lose out on these prices and most likely will never see sub 0.1 or even 0.2 again in the very near future.
Cam (the gentleman who recently passed) did most of their social and website stuff. He was there since basically day 1 of the company. Wouldn't be surprised if he was the one who controlled that site. I know there are others who has access to Cam's files so I'm sure they can figure it out.
I didn't know Cam on a very personal level, but damn I'm so bummed he passed. They are so close and I wanted him to see this through. Really bums me out.
I think he's just pointing out that the offering is selling and we now have more cash. A lot of interest in the company right now.
I'm getting every share I can get now. Don't see sub .10 happening soon.
I believe they stated that these tests can be used for future indications. They also said in the near future they'll be doing test on mice for lung cancer.
I agree take profits, but if time is on your side (this is to anyone) than keep some shares long term.
Ah yes the big word material. Words are hard sometimes. lol thanks!
I have a feeling someone might bring up the fact that they didn't announce the BDD submission prior to being granted it, but that may be apart of the EFS program they did and or the first BDD submission was just used/over turned.
Absolutely just my thoughts I'm clueless when it comes to that stuff.
Maybe someone can answer this, but I wonder if he has make the IDE submission public news due to it possibly being considered company changing event or whatever.
I can't imagine a world where the FDA grants the BDD to a company who they've been talking to and reviewing for over a year and not give them the IDE approval.
That would be insanity. At this point it's guaranteed in my eyes.
You mentioned you've been in other investments with drug companies. Have you been in anything else like medical devices? Very interesting comparing the two.
I laugh a little when people look at the finances of a biotech company who's making a product. Like basically any company whi is making product isn't going to be in profit until they sell it big time.
I do like this though cause it shows they're not millions or billions in debt lol. Very clean books considering the company's past CEO and R&D
I'm wondering if the FDA just used their last BDD submission with updated data and what not.
I got it up there for ya.