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Don't be surprised if the FDA doesn't respond in any way. That is good news as after 30 days with no response from FDA, the application is then considered approved.
Well written and the company will likely move to the Nasdaq some time after phase 1 trials so institutional investors will gobble this up
If fishy...I would initially lay blame on the FDA (if we don't get FULL approval for IDE) but would be interested to hear what RDGL has to say about it.
Very unusual to see “calm before storm” when pending FDA news. Normally it’s the other way around. This can be something YUGE or something FISHY.
The calm before the storm. I am betting all of my 320k shares that once we get IDE approval from FDA this will 💣💥.
Of course, I could be wrong, and the market will not reward longs with the share price we all believe we should have after approval.
Time will tell. 🤞
Spoke with my brother in law today,he's exited about Radiogel and will also be buying in. I wasn't liking the the low price either but this will help him get in before this heads way north.GLTA
I agree Big Al T. With BDD and EFS, they could start and complete Phase 1 in just a few months, by end of Q4, depending on how quickly Mayo gets the required patients.
Yep, could be a "blessing in disguise" soon for people who didn't sell at submission news. When trial protocol is finally announced and folks see how short ph1 duration is, their horizon and outlook will most likely change as well.
LOL, what a phony! As if you're disappointed, right? The manipulation season is nearing a close and some people on here will have no air to preach passive aggressive toxic positivity any more.
More like "depressing"...
"Second, once FDA grants IDE approval, and start of phase 1 for the thyroid trials is announced, I expect market will react very favorably and strongly as radiogel as already been proven very successful and safe with pets".
Consequential paradigm shift is what will happen post FDA IDE clearance. Market sentiments will improve significantly IMO.
Very very interesting price action, volume, silence, while being sooo close to finding out the destiny of the company.
Exactly and remember BDD from FDA is the catapult imo to obtain IDE APPROVAL and marketing the product without a fishbowl
For all the Karens bagging on Isopet as a waste of time and money, without Isopet, Vivos would not be at this point now waiting on IDE approval. All that testing and patient data from Isopet was used for the IDE submission.
Second, once FDA grants IDE approval, and start of phase 1 for the thyroid trials is announced, I expect market will react very favorably and strongly as radiogel as already been proven very successful and safe with pets. The initial human trials should go quickly and smoothly.
I’m taking it as a positive.
Someone needs to get a job. Too much time on their hands with irrelevant & pointless posts that are always obvious & self serving.
Someone implied I was worried about the 60ish comments, I'm not. I have never mentioned them. Vivos has addressed all questions and even repeated some tests that the FDA didn't ask them to (Korenko knows from past experience that more tests can pop up at any moment) and cleaned up all documentation and websites in anticipation of what could be commented on. Again going above and beyond what FDA asked/mentioned. Korenko has doing everything within his power to have this submission address all possible issues. I think the genotoxity was a complete curve ball thrown at them. They have a lot of experts (vets, radiation specialists, FDA consultants, etc) and it is obvious Korenko said consider everything the FDA could bring up at this point and lets address it before submission. Now we have to wait and see if team Vivos was succcessful with that brainstorming or the FDA has another surprise up their sleeve. If they do it will be an out of the blue like the genotoxity BS.
weak again...you must try harder
I think I recall you were at the treatment of Zippy the therapy horse? Been meaning to ask for a long time how he was doing. I figure no news (from you or Vivos) is bad news, but I hope I am wrong. I dug up my tax receipt (from the donation) and it looks like the riding center isn't in business anymore. At least no social media updates in over a year. If so that would be a bummer too.
Agreed. It appears ALL SYSTEMS ARE GO as I stated in my last post. RDGL$.
from submission PR: “We are appreciative of the improved communication with the FDA since receiving the breakthrough designation”
some here need to relax about any newer FDA reviewers not being clear on a few things, they’ve been in the loop, Vivos addressed it all
NO NEWS IS GOOD NEWS IN THIS INSTANCE
And I would be hard pressed to believe that the likes of MAYO and others would be heavily involved if there really were any serious questions as to the drugs efficacy . Every day that goes by with no news increases the chances of it being approved exponentially
ALL imho
I agree with this completely.
Might be construed as a positive that we have not heard anything from the FDA or company yet with regard to additional information being required.
No fish bowl ??? LMAO
Because if 3 cats were there....lol
This board is becoming bored with lack of patients lol...but we will be treating outpatients soon enough imo
Get on board slackers
Hope we get the response soon
Will we run out the clock or will FDA give a response before 30 days .Think we have less then 14 days left.what would be better for $$$$$
Totally agree on all points
Agreed MC73.
I don't think there will be a big sell off after approval. I think a lot of old longs are trapped waiting for approval. Many, myself included wanted to unload some on a IDE Submittal pop. Now that I am forced to hold and wait for approval, there is no way I sell after approval. Upon approval we will be waiting for Phase 1 results. I am 99.9999% positive of positive results. IDE Approval is the only road block in front of us at this time imo.
I dug up the Instagram 'reel' and was able to watch that w/o having to get an instagram account.
https://www.instagram.com/isopet.cancer.therapy/reels/
The video shows the marketing lady (I think the other two are mostly support and she would need help setting up, tearing down, and keeping the booth supplied) working hard and engaging with attendees. I haven't changed my mind about the fact having someone there who had used the product there would be advantageous, but she was definitely engaging with others about the product and working hard. I didn't see a fish bowl for a give away, so the video of someone writing down information while the marketing lady waited could have been for followup from the company about becoming a clinic. Having the peltier chiller on hand to hold and use as a visual aid is great and she made use of that.
Based on this video, my comment in my earlier post that "If IsoPet is at the point of being able to attract new clinics by having three ladies pass out brochures that is fabulous. But I don't think we are." looks to be wrong. It does appear that the existing marketing can be successfully done w/o a scientist of veterinarian who has used it on hand. The display, the demonstration chiller, and yes, even the Dachshund (Finnegan?) was puling the attendees to the booth. No tee-shirts needed. Just candy and brochures/pamphlets and a enticing product on easy to digest posters. I still think that if a vet that had used the product wanted to go to a conference that it would be worth the companies money to send them in return for two hours a day at the booth to talk to other vets.
I definitely don't want anyone from Vivos at a conference now. They need to be focused on being available to and responding to the FDA.
I'm glad someone else is being proactive! 😂
You’re not the only one, well maybe you’re the only one on twits, but there’s several others reaching out beyond IHUB and stocktwits
I’m not sure if you’re reading that right, but when I read roof’s post to yours I could clearly tell he was insinuating that you have only been to parent teacher conferences not med/science conferences. It was definitely sarcasm and nothing was disparaging towards teachers or students in that post, other than letting you participate in the conference. Jk
Yet, I'm the only one shamelessly pumping it on other message boards.
Yes and that theory is very obvious...it will be like a herd of stampeding Buffalo when the gate opens...
I like your theory on that ….
And that could very well be true, once they get approval on humans.
It makes a lot of sense.
"Probably not the most likely but not zero either" You and ASCM seem to basing your skepticism, that the FDA will punt this go round, on the number of items (63) the FDA requested further clarity on. But more so because of this one paragraph from the Jun 28th press release announcing application submission.....I won't ridicule you for that. But I do take exception to your deceptive style of posting. Some of which we have witnessed again here today. I've said this before and I'll say it again. Very odd behavior for someone who claims to be long here....your living proof rock bottom still has a basement.....
I think many eyes are on this and also all of those eyes have seen prior submittal(s) get rejected. I betting as soon as we have approval the flood gates open. 🤞
if enough people know about it ….
we should for sure surpass that.
Maybe not in the first 24 hours, but eventually soon after.
We need people to know.
in due time for sure they will.
But hopefully people find out about it sooner.
Is anyone still thinking we hit $1 after IDE approval?
TRUTHSOCIAL
I agree 100%
MY OWN DR is one of those
I saw him about 2 months ago shortly after the 59 page report on deaths and injuries from the vax was posted by the CDC, He asked if I had gotten the jab yet, I TOLD HIM NO as I have said since they came out, with that I asked if he has read the 59 page report from the CDC about subsequent deaths and injuries, his comment was "" WELL I HAVEN'T read it ALL YET!".
I looked at him and said DOC you disappoint me very much and he h said WHY, my response was YOU'VE NOT READ ONE SINGLE PAGE OF IT as it was all REDACTED and BLACK OUT so you could read nothing, you should have seen the look on his face
I like to add more shares before IDE approval, not after when PPS will be too expensive. Now just waiting for cash.
Exactly. We'll never become a meme stock 😭
Their web guy needs to update the red banner on their webpage from
"We are on track for IDE Submission to use RadioGel® in human clinical trials."
to
"We have submitted our IDE to use RadioGel® in human clinical trials."
Majority of investors don’t even have or bother with a iHub.
Ooh, I realized after the fact that was a joke and you are making fun of teachers and or students? That makes me sad. We need teachers and we need students. FYI, I still take classes and when I retire I hope to do some teaching. Education is nothing to mock.
My default is that I mispelled a word, so I just believed you. Please feel free to insult me me but figure out how to do it without making any teachers on this board feel unappreciated.
When we get the IDE, Korenko needs to start having quarterly conference calls. Some OTC CEOs do this, in fact I am pretty sure Katzoff had them in the early days. If they weren't regular quarterly CCs I believe he did have a meeting or two that we could join on line and listen to. Korenko doesn't have to answer questions on the fly but taking some ahead of time and answering our questions would be a good way to developer investor confidence.
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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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