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Relax. Say it with me…. RELAX. Everything is gonna be fine. 2 years from now when you are sitting on big money, you will not remember if the IDE was granted +\- 45 days from the target
You are a broken record. Nothing you say is true
$RDGL HUGE development that RDHL is having a Sprint discussion with FDA…Vivos Inc.'s Sprint discussion with the FDA is a promising step toward the company's goal of initiating human trials for RadioGel at the Mayo Clinic. The expedited communication and streamlined feedback facilitated by the Sprint process can significantly accelerate RadioGel's development timeline.
By fostering agreement on key points and addressing any potential concerns upfront, the Sprint discussion increases the likelihood of securing FDA approval to begin human trials. This positive momentum builds upon RadioGel's existing Breakthrough Device Designation, suggesting a potentially smoother path toward regulatory clearance.
The collaboration with the Mayo Clinic underscores the significance of this development, as it sets the stage for crucial clinical research that could ultimately bring this innovative cancer treatment to patients in need.
We are super close and I will be adding shares big time on TUES
https://www.tricitiesbusinessnews.com/articles/vivos
Great article… shows the massive potential here. Mayo Clinic is just waiting by to support as soon as FDA gives the green light
Posting again— for those that didn’t read earlier. Get off the cliff, everything is gonna be ‘aight
This is not bad news, it’s a strategic move, not a set back. FDA is incompetent and basically told them that by suggesting the conversion to allow the review to complete. Summary below:
The FDA has been unable to complete its review of Vivos' (RDGL) Investigational Device Exemption (IDE) application for RadioGel within the standard 30-day window. This is not uncommon for complex medical devices. To ensure a thorough review, Vivos and the FDA have agreed to convert the application into a Pre-Sub filing. This allows for continued dialogue and gives Vivos more time to address any remaining questions or concerns the FDA may have.
Key Points:
* Conversion to Pre-Sub: This is a strategic move, not a setback. It allows for a more comprehensive review process and ensures that all aspects of RadioGel's safety and efficacy are thoroughly evaluated.
* Ongoing Communication: Vivos is in active communication with the FDA and has already responded to multiple rounds of inquiries. This indicates a collaborative approach and suggests that the FDA is taking the application seriously.
* Confident Outlook: Vivos is confident that they have addressed the majority of the FDA's concerns and are well-positioned to resubmit a refined IDE application within the next 45 days.
* Collaboration with Mayo Clinic: Vivos is working closely with the Mayo Clinic and plans to submit their treatment plan to the Mayo Clinic's Independent Review Board (IRB) as soon as the IDE is approved. This suggests that Vivos is confident in the clinical potential of RadioGel and is preparing for its implementation.
Impact on IDE Approval:
The conversion to a Pre-Sub filing does not necessarily mean that IDE approval is less likely. It simply means that the review process will take longer. Vivos' confident tone and proactive approach suggest that they are addressing the FDA's concerns and are committed to obtaining IDE approval. The ongoing collaboration with the Mayo Clinic further reinforces this positive outlook.
Overall, while the review process is taking longer than initially anticipated, Vivos seems to be on track to address the FDA's feedback and secure IDE approval for RadioGel. The collaboration with the Mayo Clinic is a significant step forward and suggests that RadioGel is moving closer to clinical implementation.
$RDGL CEO Korenko picked up 50000 shares today at $0.09… doubt he’d be doing that if he didn’t feel VERY confident that they will get this IDE
This is not bad news, it’s a strategic move, not a set back. FDA is incompetent and basically told them that by suggesting the conversion to allow the review to complete. Summary below:
The FDA has been unable to complete its review of Vivos' (RDGL) Investigational Device Exemption (IDE) application for RadioGel within the standard 30-day window. This is not uncommon for complex medical devices. To ensure a thorough review, Vivos and the FDA have agreed to convert the application into a Pre-Sub filing. This allows for continued dialogue and gives Vivos more time to address any remaining questions or concerns the FDA may have.
Key Points:
* Conversion to Pre-Sub: This is a strategic move, not a setback. It allows for a more comprehensive review process and ensures that all aspects of RadioGel's safety and efficacy are thoroughly evaluated.
* Ongoing Communication: Vivos is in active communication with the FDA and has already responded to multiple rounds of inquiries. This indicates a collaborative approach and suggests that the FDA is taking the application seriously.
* Confident Outlook: Vivos is confident that they have addressed the majority of the FDA's concerns and are well-positioned to resubmit a refined IDE application within the next 45 days.
* Collaboration with Mayo Clinic: Vivos is working closely with the Mayo Clinic and plans to submit their treatment plan to the Mayo Clinic's Independent Review Board (IRB) as soon as the IDE is approved. This suggests that Vivos is confident in the clinical potential of RadioGel and is preparing for its implementation.
Impact on IDE Approval:
The conversion to a Pre-Sub filing does not necessarily mean that IDE approval is less likely. It simply means that the review process will take longer. Vivos' confident tone and proactive approach suggest that they are addressing the FDA's concerns and are committed to obtaining IDE approval. The ongoing collaboration with the Mayo Clinic further reinforces this positive outlook.
Overall, while the review process is taking longer than initially anticipated, Vivos seems to be on track to address the FDA's feedback and secure IDE approval for RadioGel. The collaboration with the Mayo Clinic is a significant step forward and suggests that RadioGel is moving closer to clinical implementation.
Exactly. APPROVAL with conditions is still approval and means that the follow up info requested can be provided with 45 days.
Lots of Investors here may not grasp that… approval of any sort is a great outcome and means that we are on our way to conducting human trials— which is needed to enter into the most lucrative market here
It’s possible that the clock didn’t start until FDA acknowledged receipt of the IDE submittal— if that’s the case, the 30 days won’t end til this coming THURS. anyone who sells before the announcement is going to be sorry imo. Most likely case is conditional approval as I’m sure there will be a few remaining questions FDA will have on that much info submitted. Don’t be confused, this outcome would be GREAT news and would likely mean that FDA believes any questions can be answered within 45 days. Complete and total approvals are very rare. Hold strong everyone— we know the therapy WORKS and KILLS CANCER. Think about that for a min.
Is this post a joke? LOL
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.
I can’t imagine selling at this point. They are so close to IDE approval, the chance to miss out on 2x to 5x gains in short term are very high. We should get good news in the next 7 business days
Yes, great post. If all longs want that to happen, they need to do THEIR part. I’ve emailed vet clinics, sent the news links, tagged vet groups on their twitter posts, told family and friends, posted in Reddit, and other forums about this stock to help drive exposure. If ALL longs did this, it would be immensely helpful for this company who’s trying desperately on a shoestring budget to educate the world about a truly groundbreaking therapy they have that actually works to kill cancer. I sincerely hope this post motivates even a fraction of my fellow longs to do the same. Take some initiative and help be the mouthpiece for RDGL. All of us can help adoption and exposure. This will help drive investment and bring up the price quicker.
Here is Google Gemini’s take on the likelihood of IDE acceptance and the impact to stock price:
5x to 10x returns!! I’ll take it.
Vivos, Inc. (RDGL) and the Potential Impact of an FDA IDE
Likelihood of Obtaining FDA IDE
Vivos, Inc. has already submitted an application for an Investigational Device Exemption (IDE) for its RadioGel™ product. The company has also received Breakthrough Device Designation from the FDA, which often expedites the development and review process.
Factors influencing the likelihood of obtaining an IDE:
Strength of preclinical data: The quality and robustness of the data supporting the safety and efficacy of RadioGel will significantly impact the FDA's decision.
Clarity and completeness of the IDE application: A well-organized and detailed application that addresses all FDA requirements will increase the chances of approval.
FDA's resource allocation and workload: The FDA's current workload and priorities may influence the review timeline.
While there's no guarantee of FDA approval, the factors mentioned above suggest a reasonable likelihood of Vivos obtaining an IDE.
Potential Stock Price Impact
If Vivos successfully obtains an FDA IDE, it would be a significant milestone for the company, as it would allow them to initiate human clinical trials. This could potentially lead to a substantial increase in the stock price.
Factors affecting the potential price increase:
Market perception of the IDE: Investor sentiment towards the IDE approval and its implications for the company's future prospects.
Overall market conditions: General market trends and investor appetite for biotech stocks.
Competitive landscape: The presence of other companies developing similar technologies could impact the valuation.
Potential price increase:
Given the speculative nature of the biotech industry and the early-stage development of RadioGel, a significant price increase (e.g., 5x-10x) is possible if the market reacts positively to the IDE approval. However, it's essential to consider that such a dramatic increase would be highly volatile and dependent on numerous factors.
A more conservative estimate might be a 2-3x increase in the stock price if the IDE approval is accompanied by positive clinical trial data and a clear development pathway.
Important Considerations:
The biotech sector is known for its volatility, and stock prices can fluctuate significantly based on news, clinical trial results, and overall market sentiment.
It's crucial to conduct thorough due diligence and consider the risks involved before investing in early-stage biotech companies.
What idiot sold at the end of the day? I hope they miss out on the explosion to come.
You all need to chill the F out. The Bull case is not only intact, but it’s strengthen significantly over the past week. The biggest payoffs come with patience. As George Sharp posted on X— there really is untold upside to this when FDA IDE approval comes, which it will. Don’t let fear/emotions cloud what could be a 50x bagger in the next 12 months
LOL… idiots selling shares right now will be so sorry once FDA approves their IDE application. Know what you own. This company literally couldn’t be in a better position to access the massive oncology market. Their treatment WORKS. It’s going to be a key tool to fight cancer. Novartis, Mayo Clinic, Johns Hopkins all involved in RadioGel. We will get rid of any flippers here soon. Hold and add— in 30 days you will be glad you did
HUGE DAY… as a reminder— this is not a ‘sell the news’ play. This submission marks the start clock on the BIG pay day of IDE approval. This means we can begin human trials in concert with the two most prestigious cancer reach institutions in the world (Mayo Clinic / Johns Hopkins). The treatment works and will be an important tool for oncologists. Anyone who sells now will miss the fireworks coming soon. BULLISH AF
The PR isn’t on the website yet— this was an email alert to all investors that signed up for alerts. I got it in my inbox. PR and post on X coming any min
Everyone can settle down. I was told today that the IDE submission is still on track for Q2.
Yes, I’d agree it’s conservative. Hopeful for higher and it very well could get there
Well that’s crystal ball time— but I could see $0.40 easily if they get positive attention and volume based off the submission and anticipation for human trials
Dude, they have said probably a half dozen times they are on track to submit by end of Q2. No reason to think that won’t happen. Even if it doesn’t happen by FRI, the submission is imminent and all the longs here know that RadioGel actually WORKS and regardless if the piece of paper application is submitted one or two days/weeks/months that won’t change. What will change is the share price once all this finally does go down… anyone who panic sells will be very very sorry
I’ve spoken with the company Marketing POC and they advised they will 100% announce the submission of the IDE on their social media channels as well as a Press Release. My guess is that they will use the Bezinga article as well to reference the submission. This is a great time to be an investor— I don’t give a shit if there are some red days this week. Mark my words the price will be much higher 3-4 weeks from now
Honestly, that is what I have been saying for a long time. EVERYONE here needs to do their part on a daily basis to spread the word about this gem of a company. The treatment WORKS. They are so close to FDA IDE approval and they should be trading over $0.50 now—- which I bet they could be if more investors knew. Please help the cause and spread on Reddit / LinkedIn / Facebook / whatever… each. and. every. day!
Everyone on this board needs to due their part to drive exposure towards RDGL. Make a post on Reddit / FB / LinkedIn / X TODAY. I guarantee you any investor that has any talent for evaluating promising investments will be interested. All longs here need to be a force multiplier for Vivos’s marketing arm… it will benefit all of us. Now go out there and spread the word!!!
It also wouldn’t be bad if they were doing it based on discussions / interest from institutional investors who want to invest directly with shares. The market cap of the company stays the same, there is no dilution, and the share price goes higher. Could be good to uplist and attract more investment. Regardless, that is at least 12-36 months away. The share price will increase tremendously after human trial data is released. We all know that the treatment WORKS, which is the most important aspect of all this
The large institutional investors may have restrictions in place for sub $5.00 stocks, but that does not prohibit them from investing directly in the company is private equity or venture capital investments. It’s likely RDGL could up-list once the human trial data comes out and the share price goes up significantly. If they are at $1.00 to $1.50 (which is not crazy) they could even do a reverse split to get to the $5 level and open the shares up to large institutional investors
No— I’m going off what they’ve said publicly on the matter, which is in Q2. That leaves up until June 30 they could submit.
The Bezinga info was provided to me by the company.
Bezinga has around 25 million readers per month including 45 million monthly views. Their reach also includes 240,000 brokerage partners and more than 700 large institutional investors.
A well done informational piece on RDGL will have a positive impact in getting exposure to those investors and educate them on the success of IsoPet and RadioGel has in killing cancer.
This company has always struggled in getting enough people to actually understand just how game changing their treatment is— hopefully the Bezinga article will drum up more interest.
Regardless, the FDA BDD designation and likely IDE approval confirm what all of us have know for a long time— this is a diamond in the rough company that will change the face of cancer treatment soon!
Share price will be up significantly in the next 12-24 months
Apparently the Bezinga people are complete idiots. Not the first time I’ve heard about Bezinga dropping the ball. Regardless, the informational article on RDGL should be beneficial to drive exposure. We have a little more than 1 month until submission. This will be a good time to load up on dips. We will easily pass $0.25 upon news of IDE submission and likely much higher once accepted.
The Benzinga article will come out soon— be advised, it’s not going to say anything ‘new’ rather it is an informational article meant to educate potential new investors about the company and drive more exposure during this key time pre IDE. I spoke with the company and apparently the idiots at Bezinga lost their information and wrote about the wrong Vivos. The ‘delay’ is outside RDGL’s control but I was advised that they are staying ‘on them’ and it will be soon.
Also— all longs on this board need to chill. Hold what you have, and DO YOUR PART to help drive additional exposure. Repost and tag relevant organizations on their Twitter posts. Post on Reddit/LinkedIn/etc to educate others and get more eyes on this company. I’ve sent their NBC News segment veterinary groups, magazines, etc and have received some very positive replies. Don’t under estimate the power of all of us working collectively to spread the word.
Have faith, go out and do your part and realize that we are on the cusp of immense success with the FDA.
$RDGL Guys— KNOW WHAT YOU OWN. This is an amazing time for Vivos right now. It’s hard to believe anyone would sell at this time, given the key catalyst for RDGL— the anticipated Investigational Device Exemption (IDE) submission to the FDA will occur by the end of Q2. This green light would allow Vivos to begin human trials for their Radiogel therapy, a potential game-changer in cancer treatment.
Successful human trials will -00% propel RDGL to new heights. Investors are hungry for positive FDA results, and with them will come a surge in stock price. Selling before these trials even begin means missing out on significant gains.
Beyond the IDE
Also— Vivos isn't a one-trick pony. They already boast:
FDA Breakthrough Device Designation for Radiogel, highlighting its potential.
Commercially Available IsoPet for Animals: Providing revenue and demonstrating the technology's viability.
Expanding IsoPet Network: Three new certified clinics for wider animal treatment reach.
The Takeaway
Q2 is shaping up to be a pivotal time for RDGL. With the FDA IDE submission looming, there's a strong chance of positive developments that could send the stock price soaring
Where did you first see it? I shared on multiple sites for years now— hope it was me!
Can you post the link? Can’t find the report
That’s not it— the clowns who claim they are all ‘longs’ need to stop f’n selling right now. This is a time to load and wait— not dump.
Exactly. Anyone who is a true long here and has sold this week is part of the problem— you are mucking this up. Stay patient and go for the BIG return.
Honestly, for those that are thinking of selling here, at the first leg of the march up, I feel bad for you. When the new PRs come out and the news regarding IDE comes and when they confirm submit
This is going to go much higher than the first peak we hit. There won’t be an opportunity to get back in… I’m not making that mistake. I’m holding this at least until FDA approves IDE and will hold the majority of shares until data from human trials comes out— which will be CRAZY since we all know RadioGel already works. You can say hello to dollar-land once that happens, and in my opinion that’s closer than most think. 1-2 YRS tops
$RDGL GUYS— this breather is a good thing. Need to consolidate for the next leg higher. Remind yourself that the bull case is not only intact, but incredibly strong.
IDE will be submitted over the next 60 days and it has a VERY high likelihood for success. We have the Bezinga article coming out soon as well. Don’t make a mistake and panic.
The last huge run in 2021 saw a consolidation after similar massive gains and it stayed down for about two weeks before ripping higher than before. GOOD THINGS ARE COMING
I would just like to take a moment and say ‘HA HA HAH’ to one very quiet troll. His name rhymes with hate.