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Yes looks like a lot of accumulation. I also need some more before the explosion:))
Lol love the paint every day at closing
There’s been a lot of accumulation in this .10 to .11 range over the last week
Nice dream but a little too soon to talk like that imo. Years, if ever, away from a buyout.
Thank you! Interesting in that the clinic had gone through training which means that they actually used the product. This doesn't worry me as there could be any number of reasons and I did find it odd/interesting that a surgical center was wanting to use the product. I thought this because IsoPet is a product that could decrease the number of surgeries they do. If you look at the website for the NY Surgical Center on Long Island almost all services offered are related to surgery and rehabilitation from surgery. Yes, treating margins is a valid use of radiogel/isopet. But if you were a pet owner might you not want to ask..."why not skip the surgery and just do the injection of IsoPet then we can see if we need surgery at all"?. My belief is you shouldn't go to a surgeon unless/until you have decided you need surgery because surgeons love to cut! The prospect of using Radiogel and cutting less probably didn't sound appealing to some if not most of their surgeons. Plus it probably would have been less profitable. My guess is one or two forward looking surgeons there wanted it but the clinic as a whole decided it didn't fit.
Just an update for you. I reached out and company said "after much effort on our part they declined to be certifed".
Oh yes..the ADMD days. And another fun fact. The favorite word used by Ex slimy CEO James Katzaroff was “Alacrity”. Which of you were ever taking to him and he used that word, he was about to ask you for money.
Just for human side
Getting a lot of chatter on Twitter/X from some pretty well known investing accounts. After all this time it warms my heart. We've come a long way from ADMD days.
Hold the line! 😁
And that has what to do with a buyout, looks like absolutely nothing
All types of traders are starting to come in,
Most will be day traders so they will do what they can to manipulate the price.
And guess what, this will be happening on a regular basis, especially on Thursday/Fridays so that the day traders can get their beer money.
It’s nothing new and has zero to do with a buyout.
And yet yesterday's trading pattern looked to me like maybe 100 share/200 share low ball trades trying to trigger "stop loss" share sells for someone to pick up cheap volume.
Some of us have seen what THAT looks like before, short term... lol
If a buyout happens it won’t happen for a couple of years. Again if which is a pretty big if at this point.
Don’t get your hopes of a buyout happening anytime soon if at all.
Over a $2 billion buyout ….
Dr. Korenko’s ultimate agenda appears to sell this to big pharma in the billions range.
Even a $2 billion buyout puts us at or above $5.00 per share.
I didn't forget! I had been wanting to hear the results of that use case, so based on your comment I went through this years 10K just now to see if that clinic was still mentioned and it was not. In the March 2023 10K a clinic was mentioned that had gotten training and part of their plan was to specifically test the use of radiogel around skin that had surrounded a tumor surgically removed. This years 10K doesn't mention that center so for some reason it never finished the necessary requirements and started using radiogel. Sure would like to know why....wonder if it was an issue with getting their Radioactive Material Handling License. That might have been too costly in NY or at least difficult.
From last years (not this March but March 2023 10K)....
Sometimes it's best not to ask questions... lol
Ahh, crap! Now that I said that out loud Imma gonna hafta recycle more cans tomorrow n pick up a couple more shares...
Next time someone chats with Dr. Mike, maybe they could bring up patient immune response testing and share a reply here?
Pre-mRNA vaccine, virus cells with inactivated DNA were grown and used as the vaccine for flu, measles, etc... Given that the patient absorbs the tumor post treatment with Isopet/Radiogel, is there a way to test immune response in the patient to the absorbed tumor cells? Can a successful Radiogel/Isopet treatment be demonstrated to create a patient specific immune response similar to vaccination for future occurrences of similar cancer cells/ tumors?
Just spit-balling potential pieces of the iceburg here...
-Go $RDGL
I’ll take it!
If I had heard about that potential aspect of business, I forgot. Thank you for posting!
Exactly some forgot the iceberg melting
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.
The ask briefly hit 1094 at the close
That was an odd close.
Last 0.1094 +4.79% (250 shares)
BID/ASK
0.1055 / 0.1055 (481600 x 5000)
Flippers don’t care, they are happy then shit if they can make at $250 or more a trade.
This will continue to happen for awhile now
Today's flippers sold below 0.10 are so stupid when they can easily sell over 10 cents See break out 015 by Friday.
Some flippers sold at bid to take some small profits, long hold strong and added more shares at cheap. Trading are healthy to consolidating over 10 cents. RDGL is ready to run again.
Weird, weird, weird trading.
LFG!
11c+ again!
$RDGL
New 52 week high today .
Just the beginning ,, imo
Told ya the lights would be coming on soon and they’d scatter .
Lights still dim but they don’t like any light
Thank you. Either way, meeting or no meeting...I know we have everything needed foe an approved IDE after we submit. Exciting times ahead!!
Reading the INFORMATION from FDA helps understanding the process tremendously most documents are digital.
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-related-topics
https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide
https://clinicalcenter.nih.gov/orcs/ide.html
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-definitions-and-acronyms
https://www.fda.gov/medical-devices/investigational-device-exemption-ide/expanded-access-medical-devices
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3448842/
Hope this helps understanding IDE AND IRB etc
I would think we would want to hand them copies of all the recent tests and have them tell us everything is good to go for submission.
No more meetings necessary.
Does anyone else think another meeting with FDA will happen before IDE submission? I do. I also think this meeting will need to be announced in the next month or so.
Thoughts?
Hm, the CEO is an MIT guy who got his device designated as a "Break through Device" by the FDA in a biomed market where such devices already have a 20 year history of being FDA approved... AND his device is already FDA approved and used in the Veterinarian community by doctors?
With a share price of 10 cents, maybe I'll finish this beer n then go return some weekend bottles n cans so I can buy more shares over the lunch time sell off!
1 empty recycled can per share? Volume could show up any day now...ROFL
-Go $RDGL
Maybe it’s because it hasn’t started trading yet.
Getting more and more difficult to pick up cheap shares.
When BDE (BDD?) was announced for submission (years ago), the price went to .30. I would have to say that when IDE is announced for submission that it should go a lot higher. IDE is light years ahead of the BDE (BDD) submission.
SUBMISSION: 04 to .50.
Whoops, I like to link to info I refer to whenever I can. We have had multiple rabbit studies done, written up and submitted to National Institute of Health, etc... despite what some fudsters may have claimed. I link an old May 2021 write up as a reference for anyone new here:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996238/
-Go $RDGL
Pre-submission share prices will likely be market driven. Timing matters.
Dr. Mike has always been clear in his communication regarding FDA and why. He says stuff will be ready to support our IDE this quarter, then that is for real...
Is it possible FDA won't receive it for review till July? I guess we'll find out, lol. Mebbe it gets submitted by Mother's Day?
Given our recent BDD status award and level of ongoing communication combined with our genotoxicity and rabbit tumor results, mebbe FDA won't need 30 days to give a go ahead for our human safety trial?
I think timing drives events that drive share price as we see results.
Bottom line: Does the deep state US or this Administration want good news on cancer therapy pre November? Post November?
I think it promises to be a fun show to watch!
-Go $RDGL
Feels like pie in the sky, but sure hope you’re right, I’m a private investor in the company and would love to see those numbers
Macro Overview: Cancer costs by 2030 estimated to be in the $580 Billion market cap range.
Source:
https://www.globenewswire.com/news-release/2022/01/21/2370991/0/en/Oncology-Market-Size-to-Hit-US-581-25-Billion-by-2030.html
Brachytherapy is forecasted by some to reach $1.62 Billion in revenue by 2030. at a 10X multiple (I think Biomed has higher profit margins but 10% is conservative) that looks like $16.2 Billion usd (less than 3% of cancer market) in cancer Market share
Source:
https://www.grandviewresearch.com/industry-analysis/brachytherapy-devices-market
Cancer cases globally are expected to grow 77% by 2050.
Source:
https://www.iarc.who.int/wp-content/uploads/2024/02/pr345_E.pdf
I figger RDGL might get 10% of the brachytherapy market cap with their 18 revenue verticals identified by their distinguished MAB (Medical Advisory Board).
My guess is that they dilute their shares (111 million additional OS) in an offering once their pps is comfortably over $1 usd to raise mebbe $100 million usd to fund their growth.
At 500 milly OS, with $100milly in hand looking at a possible $1.62 Billy Market share and a 77% 20 year growth rate a price per share around $3.24 seems reasonable to me. That COMPLETELY ignores the veterinarian side as well as an expansion possibly into joint pain treatment, etc,,,
If a company wants to buy us out to preserve their own market share and possibly grow it, I imagine a $5-$10 per share buyout range might be reasonable.
Our brachytherapy has higher quality gel, NO resin/glass/metal beads, and uses a beta emitter with about a quarter inch emission range that is completely depleted in under 3 days anyway... mebbe targeting 10% of the 3% cancer market assigned for brachytherapy is too low ball?
-Go $RDGL
Poll
1. Price target presubmission
A. greater than $.35
2. Price target on submission news
B. greater than $.90
3. Price target on APPROVAL
C. Greater than $2.25
GLTA
I think you’re too high on the first two, but yes $1+ if approved
Poll
1. Price target pre-submission
$0.29
2. Price target on submission news
$0.66
3. Price target on APPROVAL
Greater than $2.00
Selling my 5s @ 8 a few weeks back turned out to be a terrible trade on my part.
Water under the bridge at this point.
Go RDGL!!!
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The company is engaging the FDA for permission to use RadioGel™ for the treatment of advanced basal and squamous cell skin cancers. The RadioGel™ Veterinary Solutions division of Vivos is focused on demonstrating the safety and therapeutic effectiveness for different animal cancers in four different university veterinary hospitals. Vivos is positioning itself so that after this demonstration phase, The Company can begin to generate revenues through the sale of RadioGel™ to private animal clinics.
The Company currently is outsourcing material aspects of manufacturing of its product in the United States and intends to enter into licensing arrangements outside of the United States for the manufacturing and distribution of RadioGel™ in other countries.
RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to 6 weeks or more to deliver a full course of radiation therapy. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately with no risk to family members.
What are the advantages of RadioGel™?
Based upon its studies and analyses, or general application of experience with current brachytherapy devices and Yttrium-90, Vivos believes that its brachytherapy products are likely to offer the following benefits, among others, for patients and medical professionals:
•Maximizing Therapeutic Index: The short-range beta particles emitted by Y-90 deliver radiation energy within a tight range. This enables radiation to be selectively delivered to target tissues while minimizing radiation dose to nearby normal tissues. High therapeutic indices imply that more radiation energy may be imparted to target tissues, with less radiation reaching adjacent normal tissues.
•Half-Life: Y-90 has a half-life of just 2.7 days. Many traditional brachytherapy products use isotopes with longer half-lives such as 9.7 days for cesium-131, and sixty days for iodine-125.
•Optimized Delivery Method: Current brachytherapy devices place permanent metal seeds in the prostate by using up to 30 large needles. By contrast, Vivos’s Y-90 RadioGel™ device is designed to be administered in a minimally invasive procedure with small-gauge needles.
•No Permanent Seeds Remaining: Current brachytherapy devices place permanent metal seeds in the tumor. Vivos’s Y-90 RadioGel™ device utilizes a biodegradable, non-toxic polymer that is ultimately absorbed by the body. This eliminates the possibility of a long-term seed migration or other problems that may sometimes arise when seeds remain in the body.
•Good Safety Profile: Many traditional brachytherapy devices utilize isotopes that emit x-rays (akin to gamma radiation). X-rays or gamma radiation travels within and outside of the body and have long half-lives. Vivos’s brachytherapy products use the Yttrium-90 isotope, which is a beta-emitter. Yttrium-90 beta-emissions travel only a short distance and have a short half-life of 2.7 days.
•Potential Lower Cost: Yttrium-90 supplies are readily accessible and are relatively inexpensive. The elimination of the metal or glass enclosures used in traditional brachytherapy seeds greatly reduces manufacturing costs.
What is the market for RadioGel™?
Reliable sources estimate that annual sales of brachytherapy products exceed $2 billion, about half of which are in the United States. The size of the U.S. brachytherapy market for prostate cancer brachytherapy is somewhere between $90 million and $130 million per year. The market for liver and breast cancer combined is comparable.
What is Brachytherapy?
Brachytherapy is the use of radiation to destroy cancerous tumors by placing a radiation source inside or next to the treatment area. According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion. It is estimated that the U.S. market represents approximately half of the global market. Vivos believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers. The 2013 U.S. estimated new cases according to the American Cancer Society are 240,000 prostate cancer, 235,000 breast cancer, and 31,000 liver cancer.
Are there other markets for RadioGel™?
March 15th, 2016, Vivos Inc. announced the formation of a new, wholly-owned subsidiary, IsoPet Solutions Corporation, to focus on the vibrant and expanding veterinary oncology market. In August 2017 the subsidiary was changed and made into a separate operating division inside the Company.
The IsoPet™ Veterinary Solutions division will focus on bringing RadioGel™ yttrium-90 brachytherapy products to veterinary oncologists to treat dogs and cats suffering from tumor cancers.
There are over 150 million pet dogs and cats, with over 1/3 of the households in the US owning at least one dog, and just under 1/3 owning at least one cat. IsoPet Solutions is establishing the infrastructure necessary to provide product to veterinary clinics including regulatory clearances and compliance. The division will also provide product awareness and education to veterinary oncologists. Initial treatments are to be coordinated through the Chair of the Company’s Veterinary Medicine Advisory Board, Dr. Alice Villalobos.
CEO and President Dr. Mike Korenko stated: “IsoPet Solutions allows specific resources to focus on the use of our RadioGel™ Yttrium-90 brachytherapy products in the veterinary space. We believe that RadioGel™ is positioned to build a significant presence in the cancer treatment tool-kit of veterinary oncologists.”
Dr. Alice stated: "I am quite excited at the opportunity to work with RadioGel's™ team to integrate their products into the cancer treatments of companion animals. Cancer affects 50% of dogs over age ten and one in four dogs under age ten. For many years, we have been searching for a useable and effective agent such as RadioGel™ Y-90 brachytherapy devices that can be delivered into tumors on an outpatient basis. I believe that veterinary oncologists around the globe will finally have an ideal product line for the treatment of accessible and inoperable tumors."
What are the steps for FDA clearance?
Vivos met at the FDA offices to discuss next steps, expectations and required testing to progress towards obtaining marketing clearance for the Y-90 RadioGel™ device. The FDA and Vivos management and consulting team are working closely in order to obtain all appropriate data and benchmarks the FDA requires in order to proceed with providing final clearance for marketing the device in the United States.
August 2016, Vivos announced a partnership with IsoTherapeutics Group, a third-party radiopharmaceutical R&D company, to provide commercialization support and conduct additional studies as requested by the FDA for the Y-90 RadioGel™ device. IsoTherapeutics has completed the first stage of the project, comprised of tech transfer, manufacturing and in vitro testing. The next stage, comprised of additional in vitro and in vivo testing. Upon completion of these studies, Vivos anticipates submittal (direct De Novo) for FDA clearance for full commercialization in the U.S. (see company press releases for continual updates on this evolving process).
Press Releases 2018 ( Change in Company name and trading symbol • Jan 2, 2018)
Jan 2, 2018, Advanced Medical Isotope Corporation (ADMD) Announces Corporate Name Change to Vivos Inc., and Ticker Symbol Change to RDGL
Press Releases 2017 ( Change in Management & Directors Dec 2016)
Dec 20, 2016, AMIC's Board of Directors Appoints Dr. Michael Korneko CEO and Dr. Carlton Cadwell Chairman of AMIC
Jan 11, 2017, AMIC's New CEO Issues Letter to Shareholders
Feb 14, 2017, AMIC's CEO Releases Shareholder Letter Outlining New Streamlined Path to FDA Submission
Feb 28, 2017, AMIC's New CEO Releases Shareholder Letter Announcing and Discussing their Cancer Indication Selection to pursue FDA Approval
Mar 7, 2017, AMIC's New CEO Releases Shareholder Letter Detailing Launch of Veterinary Oncology Division with Radiogel
Mar 23, 2017, Update on Feline Cancer Treatment and Improvement to Financial Structure
Jul 6, 2017, AMI Requests Pre-Submission Meeting with FDA
Jul 11, 2017, ADMD Makes Significant Improvement to its RadioGel™ Brachytherapy Product
Jul 27, 2017, ADMD to Host Shareholder Update Webcast with Live Q&A
Aug 2, 2017, Advanced Medical Isotope Corp. Announces Results of Shareholder Meeting, Welcomes Two New Members of the Board of Directors
Sep 14, 2017, Advanced Medical Isotope Corporation has its first discussions with private animal consortiums to utilize RadioGel™
Independent Analyst Research and Price Target
Presentation(s) from CEO & President, Dr. Mike Korenko.
2017 - LINK HERE
STOCK SYMBOL: OTC: RDGL
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