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well stated, and good question… I still think the Benzinga article gets published Monday, with an abbreviated followup article soon after FDA approval summarizing the plan going forward… more detailed plans / progress will be covered by Vivos monthly updates
I know it’s hard to see it right now but MK is fucking genius for all this.
First, the timing of the Reg A filing was perfect. It doesn’t get approved for a while and he’s paired the offering news on the same day as IDE submission. On a Friday, and after market. To let people focus on the submission and not harp on dilution.
The reg a takes time to get approved so it won’t impact this 30 day process.
Then the timing of any other outreach/Benzinga stuff was pushed till next week.
What I’m wondering is, since the offering takes time to get approved, and even after approved, can it be amended? If our stock were to jump significantly, can he change the offering to a higher price? Meaning less dilution for the same money. And still remain attractive to investors. That’s the ideal situation.
Lastly, the wording of the PR. We expect they’ll have questions so we’ve prepared for it. To promptly answer those questions. They’re ready for anything. No surprises will catch MK slipping. This may have been what took so long.
They listed all 63 previous comments, and then came up with answers to questions they MAY have for us.
Man I love MK and I can’t wait till out stock price reflects his brilliance
I'll admit I skimmed over that...to be honest I loved every word of today's announcement but looking back at it, that is a VERY nice thing you pointed out. Much appreciated.
30 day clock has started. Dr. K is ready to quickly address any questions from FDA per the PR.
The price hasn't exploded as I hoped or thought but this announcement reminds me that I can see this becoming a preferred treatment for most or all solid cancerous tumors. Market cap of multiple billions is appropriate for such a treatment...or?
Several hurdles to overcome to get there, but it is most certainly worth the risk imo.
Several people on this forum have been here for many years and have been through a reverse split. They had faith and saw the potential and have been ride or die because they believed in the science and Dr. K. I believe that soon, their grit and perseverance will pay off handsomely. And deservedly so. It is hard for me to imagine this stock not being worth billions in 5 years. Unless they don't get IDE or human clinical trials fail, I'm holding a vast majority of my shares until we get approval for human treatment. Share price should be a bit higher at that point...
All just the ramblings of a very relieved and happy shareholder excited for the future of this company; don't take anything i said too serious. Have a great weekend everyone.
from today’s PR: “We are appreciative of the improved communication with the FDA since receiving the breakthrough designation”
solid
I think $0.31 is our next breakthrough price target, as it was the highest high since the reverse share split.
We get through that and make it a floor then we will be solid through approval and the waiting game that will be phase 1.
I expect the next month to chop between $0.24 and $0.31 once the broader market gets wind of the submission.
If I remember the numbers correctly for the last offering, didn’t the MM’s run the price to .20 to sell… so we could be looking at a run into the 30s to sell these shares.
Yes, hopefully neeing to research and interpret FDA guidelines are back. But I need to be careful about being lazy and using ChatGPT. Others on the board need to ask about the source. I don't believe it is always right at all, but it writes such wonderfully readable text. Need to find a balance of looking up stuff myself and having it vet it and improve readability.
Yes, I removed the ChatGPT generated text after reviewing the 10K. Its amazing how much I have forgotten over the years of the all the trial and error approaches we tried under the first CEO.
Once we get the IDE behind us Korenko will layout the plan for us.
Good news is when we get the IDE Mayo doctors are using it so we get real publicity and much better investment dollars. The IDE coupled with Mayo clinic approval of trials will change current investors fortunes.
30 days from now (or less) ….
Enough Benzinga buyers should be coming in to push this to $1.00 - $2.00 per share.
Before the end of July.
Everything is on schedule.
Love that our researchers are back. I remember a few years ago when we parsed every process detail to get any leg up on what to expect.
LOL, at least now you can finally be yourself versus the initial efforts at "disguising" your cover. The game is on now and we'll see which side comes out triumphant. Go Vivos!
And the 18-24 months is only a timeline for the phase 1 portion of clinical trials.
It unlikely you will see $0.15 shares as we have built a floor around the $0.18 to 0.21 level.
I would simply accumulate in the next few weeks instead of trying to get the best price.
Every long on this board and many others will be scooping up any cheap share we can and at this point any thing under $0.20 is cheap in my mind. My average price is close to the $0.09 but as soon as I get paid again I’m buying another lot.
Updating with info from 10K
Well, I wouldn’t imagine they are cheap. Benzinga offers a huge viewer count and that’s what they capitalize on.
The company is focused on approval. All of us over here have been hung up on submission, but this entire time the company already knew about the submission, and their real goal is approval. They’ve given us every indication that they believe this will be approved - increased staff, segregation of RadioGel and IsoPet, audited financials etc etc etc.
They’ve crossed their T’s and dotted their I’s. We’ve been counting down to submission and they’ve been running the clock on approval.
We have 30 days or less my friend. Unless you were planning on selling on the rise, this is not a bad sign. If you were, well, just be patient as news travels fast and we will get eyes.
From the looks of it, nothings has changed, except for the Timing of certain goals.
Time to add 6-12 Months to all sell targets. Especially if they are selling 60M shares.
I'm new here and very interested in this company. I bought my 1st 1,000 shares at $.21 today after seeing the news. It's nice to see an OTC company that is doing what they claim with huge potential while helping people as well. I assume despite the excitement of the IDE and start of human testing soon with the issuing of 60,000,000 shares at $.15 there should be some buying opportunities around that price in the coming weeks. I hope to buy some more down there if possible. Does a product like this with FDA Breakthrough Device status still go through normal Phase I, II, and III testing. It seems like that would be longer than the 18-24 month time frame, correct? Thanks!
Haha indeed. It is too bad some of our price predictions weren't right, as selling shares at 15 cents dilutes us so much more than at 50 cents.
Hopefully, this is the last sale of shares below $1. 🙏🤞
LOL
Doesn't it always?
Are these articles expensive?
Couldn't they just release one with the submission and one with the approval?
GLTA
Hope they sell for a heck of a lot more than that for a market valued in the hundreds of billions of dollars, why give it away?
Thank you
This is just them reporting the news - we have to wait for the article to come out.
I'm probably just stating the obvious, just want to be on the same page.
Have a great weekend.
They will now have over $10 million in funding ….
Including the near $1.5 million which they already had as of current before this offer, plus the additional $9 million from this new offer.
They are primed, locked, and loaded, to be bought out for $3 to $5 billion from big pharma soon.
We have 3 stickies up and 6 mods here that can have a stickie each. Todays news isnt even one of those stickies. Come on Mods, either keep a important stickie news up or step down as a Mod.
Excellent summary. This should be stickied
I love the confidence of doing the capital raise to pay for phase 1 trials and to operate the next 12-24 months! 60 million shares at $.15. Now I know why the mms held us down the last two days. They actually did us a favor. FDA acceptance must be any minute/day as they are confident being out with a capital raise to pay for everything. This is the best dilution ever! Here comes the Nasdaq after phase 1 trails are done!
Great post. All facts
Summary of what had happened:
1) Company released news and PR about IDE submission
2) 30-day clock has begun for automatic approval (fingers crossed)
3) Company is raising $9m at $0.15 to compete phase one trails and operate over the next 18-24 months.
4) Price ran up 5x on submission rumor and is chopping sideways after a brief sell off.
I smell confidence in the water so if anyone is willing to donate their shares to my daughters college fund, please DM me!
These prices one last long!
Yes we will...we are as set up for IDE approval as a company can get. Mayo Clinic on board and soon IDE approval for human testing!!
Just costs more money lol
This kind of price action, in the face of a significantly positive FDA event, is all too predictable.. I'll be looking to add what I can. We're gonna kill it.
If I took an educated guess, I would say they contracted Benzinga with news of the submission. Benzinga assessed, and stated that the article would be better timed and more productive upon approval - now, that can either be from the standpoint that Korenko is addressing a relatively new compilation of FDA panelists, who may not be familiar with RDGL. Or, it could be from the viewpoint that approval is imminent due to their BDD and current feedback participation with the FDA. Benzinga still shows support through reposting the PR.
It’s all good, we’re just waiting on bigger pieces :) :) :)
Agreed. Doesn’t make sense to send it until approval
You are probably correct as that makes sense
I built my position thinking we were in for hefty numbers upon submission, but I added more today too. I think Benzinga is timed for approval - if they didn’t publish the article this morning with submission I don’t see it Monday. And so, we wait 🙏🏻 but it’s all coming
I hate when people say this but “you don’t want to bother have shares when the fda….” But true. Probably makes it hard for some that don’t carry big long positions in the otc over the weekend.
It would be nice to have for weekend reading
Why not one for submission and one for approval!!!!!!!!
Agree 100% - it will be a positive catalyst. Will they push the article now or wait for approval? They might be waiting for approval...who knows? It would definitely help out share price as lots of new eyes will turn their gaze here and some will jump in.
Benzinga will be a positive catalyst IMHO.
Hopefully soon.
Exactly. Either way, $RDGL is super cheap right now which would allow a cheap takeover by a large pharmaceutical. It could be a small pharma too as this company has Walmart and Kmart written all over it because it is CHEAP
Or possibly a hostile takeover. Let’s see. RDGL$.
💯 the saddle is already on the unicorn. That should slap it on the ass. I would rather it come out after holiday though. Closer to investor anxiety of running out of time. That will organically generates buying. Then the article.
But why would they give the company away for $5/share when the market size of cancer is so huge? I get that $2B is a nice number, but the worldwide cancer market is hundreds of billions of $, articles posted here said trillion(s) $, but I don't know if specifically if that's for this type of treatment. Let BP bid against each other for them and pay up. Guess time will tell.
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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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