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Oh but they will be hearing soon ....big news with
Mayo clinic soon ....
The countdown is on 9 business days or less
IMO
It looks like there are no newbies at all and that's the problem. Nobody heard of this stock besides 800 people on this board :)
Longs are holding and newbies are waiting for IDE approval before jumping on board. Pretty simple.
I think we will be trading at .25 by the end of the week and in the .30's next week.
I don't do bipolar bashers well.. I just put them on ignore and be done with it LOL
He/maybe she, is a morally bankrupt individual who has been probably playing one end of the trade against the other. From what I have gathered from reading through this individuals posting history. He/she has had a exhibited pattern of this type posting behavior every since he/she first started posting here some time back. And to support his/hers position, depending on what position he/she may be holding at that moment, he/she comes on board to try to manipulate unstable traders emotions. From the desperation I can detect from his/hers recent negative posting activity. He/she may have found themselves on the wrong side of the trade currently. That would explain why he/she feels the need to chime in with post that have a negative slant without being to obvious. Appears to be a egotist convinced that some how some way his/hers post can influence which direction the PPS goes....
He has no clue or just another bashing trying to feed his control freak ego... He's going to my ignore list at #277 now... No tolerance for slim bashers.
Sorry dude but you have no clue... These are not local seminars with 20 card tables.. These are normally two to three days long. Companies don't fly in with $3k to $10k of equipment, set ups, and a couple reps for a two hour show LMAO.....
intellectually dishonest for you to infer it is merely 3 ladies handing out brochures that get tossed later, like that is the extent of it… depends on what they say, their conversations, their level of salesmanship at what IsoPet can successfully do
Exactly. :) This volume is so sad.
I have attended dozen of science/technical conferences and walked through miles of ball rooms with booths while holding my free drink and hor dourves. I understand well the dynamics of what is going on. What you say is true of well established technology that the professionals trust and for which they already have experience. In that case its about making a choice between different products based on price and some small differences in performance. But IsoPet is a one of a kind product and is having a very hard time in the market right now because it is a complete unknown to vets. If IsoPet is at the point of being able to attract new clinics by having three ladies pass out brochures that is fabulous. But I don't think we are. Perhaps a few of them will toss the brochure into their bag, but most paper work never makes it on a plane for the trip home from the conference it gets tossed before we leave the hotel. Being able to tell a veterinarian stopping at the table that there is another vet who has used the product who will be abilable table between 11 am and 1 pm would be a help in getting serious inquiries.
BTW, the vet that comes by and hangs out for 2 hours should not have to do any marketing. They would just get to sit there for 2 hours (paying off their free attendance and eating their lunch) and only talk with a vet that wanted to talk to them about using the product. They would be an added resource for information they would not be working to sell the product.
Can you elaborate please
It appears ALL SYSTEMS ARE GO. RDGL$.
I can tell you not a marketing person, I've been in marketing for over thirty years. You don't send out doctors, engineers, and so on, You send out the best marketing personnel that know their stuff, they know conventions, they know what's needs to be done, they are professional sales people that knows how to talk yo potential clients. They just don't sit there and watch people walk by. They get up and constantly walking to other booths smoothing with everyone at the convention. There is a lot more then sitting at a card table handing it brochures.
Well, I watch X (3 friggin different sites) and I don't see it there. I used to check on Linked in but they don't put much there. If they are only posting to instagram that is stupid. If they are going to use a half dozen social platforms they need to keep them all up to date....then again if its only more pictures of their stuffed animal and Dachund I don't care that I missed it.
Not we.. probably just you..
We didn't get a single peep from the team at their IsoPet booth at PacVet in San Francisco (July 11-14). I think they are sending the crew in the mini-van (not scientists) now instead of the big guys going. If true, that makes some sense given how many conferences they are choosing to attend. But it could also mean we not as successful at recruiting veterinarians at these events. Its hard not to notice when your talking to a marketing person at a conference booth. At that point you know its a waste of time to ask many questions, just get your swag, maybe grab a brochure and move on. Hopefully they are also flying in a vet from one of the hospitals providing IsoPet and has used it. To get a conference paid for, flight, and room and board to attend a conference in one's profession should be worth standing by a booth a few hours a day.
That appears to be the case.....
Whenever these are eligible for sale, they won’t be buying for .15 to sell for .18… sellers will be looking to sell for a minimum of .30
Ask moving up. Life is good.
That isn’t an opinion. That is fact
Imo Rdgl is preparing for Mayo human clinical trials for outpatient cancer treatments soon
It's an amendment to the prior filing and still hasn't been qualified so they can't sell any yet.
Yup he should have waited another couple weeks on that no doubt whatsoever
Oh well, I was hoping this Monday was going to be better than the last couple.
Come on, $RDGL, LFG!
New Form 1-A released this morning formally announcing RDGL making available 60M shares at $0.15.
Lmao
If u fools w stop giving the attention they so desire it wouldn't be soooo much fun for her
But a dozen times or more draws question marks does it not lol 😆
On average, people might need to read something 2-3 times to grasp the main ideas. If you do not re-read things you are probably aware of, or appreciate how much you do not comprehend and understand with a single read through. Especially if that read through is done as part of scanning dozens of updates, most of which are garbage.
Wrong yet again .
How many times does someone need to read something to comprehend and understand....lol
In Korenko's X post on July 9th he referred to the IDE undergoing an 'interactive' review.
Here is what an interactive review means.....long story short....things happen faster. I think an early approval is a possibility. Probably not the most likely but not zero either.
An interactive IDE (Investigational Device Exemption) review is a collaborative process between the FDA and the sponsor of a medical device. This process is designed to streamline the review of an IDE submission and enhance communication, allowing for a more efficient and effective evaluation. Here are the key aspects of an interactive IDE review:
Collaborative Communication: The FDA and the sponsor engage in frequent and direct communication. This can involve email exchanges, phone calls, and teleconferences to discuss specific aspects of the submission, clarify questions, and resolve issues promptly.
Early and Continuous Feedback: The FDA provides early and continuous feedback on the IDE submission. This feedback can help the sponsor address any deficiencies or concerns quickly, potentially reducing the time needed for the overall review process.
Focus on Key Issues: The interactive review process allows the FDA to focus on key issues that are critical to the safety and efficacy of the investigational device. This targeted approach helps ensure that important concerns are addressed without unnecessary delays.
Iterative Process: The review is often iterative, with multiple rounds of feedback and revisions. This iterative nature allows for a more thorough and refined review, ensuring that the submission meets all regulatory requirements.
Enhanced Transparency: The process promotes transparency between the FDA and the sponsor, fostering a better understanding of the regulatory expectations and requirements. This can lead to a more efficient path to approval or clearance.
The interactive IDE review process aims to facilitate a more efficient and effective pathway for investigational devices, ultimately benefiting patients by potentially bringing innovative medical devices to market more quickly.
For more detailed information on the interactive IDE review process, you can refer to resources provided by the FDA and related regulatory guidance documents.
Actually I meant Jan 28 instead of Jun or Jul 28 ….
Just kidding
We’re only 2 weeks away now (technically 15 days from now).
Just a typo; he meant June 28.
Yeah, I meant June 28.
I edited it.
That’s exactly what I meant, lol.
I think you mean June 28.
UH??? July 28.....we haven't been there yet.
Now I am really confused!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Yeah, the FDA received it on June 28 ….
It’s not like it was “mailed in” on June 28, and the FDA didn’t get it and then stamp July 9 on it.
30 days from June 28 is July 28.
Not sure why this is even a major discussion today on here.
It was submitted “electronically” on June 28.
Excellent point. Just because the Dr posted July 9 it was accepted, the effective date of submission was June 28. That is the date the FDA received it.....point blank.
If chat GPT says it it has to be true lol ...what happened to thinking for yourself
Exactly always a wench in the circle.....look at the FDA guidelines and don't read into abc.
Of course we knew the answer
Remember June 28th submitted following week was Holiday July 4th week which does not affect the 30 day calendar. So a logical analysis without throwing mud in the spokes indicates July 29th as end of 30 day calendar. SMH
We know who the skats are.....
Let's go in 2 weeks approximately for outpatient human clinical trial cancer treatments ....with Mayo clinic and IRB
Hurrah!! Monday July 29 is the date!! Only twoish weeks away!!!
Chat GPT agrees with everyone, so I am convinced.
The 30-day review period for the FDA to review an Investigational Device Exemption (IDE) and make a decision starts from the date the FDA receives the IDE submission, not from the date it is accepted. This means the countdown begins as soon as the FDA receives the complete submission package.
From my understanding, the submission was done electronically on 06/28, so receipt of submission would be almost instantaneous. As in most business/courts, most stamp received when it arrives in their “in box” and not when some intern clerk decides to open the email and then stamp it received. If submission was done after hours on the 28th, then 29th could be the stamp date.
Based on the submission guidelines everyone is already aware of, 30 days from submission date is what I'm aware of. If there is a new guidelines indicating 30 days from date submission is accepted by the FDA, can you post the link? Otherwise, you're simply overthinking stuff and drawing conclusions that isn't supported FDA regulations.
Agree 100%. I work for the government and it is a better assumption to start the clock once the FDA confirms receipt. I'm going with 07 Aug for the "no response, automatically approved" timeline.
Korenko's post that FDA received and accepted the submission was dated 7/9/2024. I think given he waited that long to announce that information we should probably assume that Korenko was notified of FDA acceptance of the submission. Thirty days from July 8 is August 7.
I think knowing whether the 30 day clock expires on 7/29 versus August 7 is an important thing to figure out. Common sense says it would take a few days for the FDA to read and consider whether the submission was complete enough to accept. So to assume the 30 days starts from 6/28 doesn't sound right to me.
Go play elsewhere
7/29/24 will be the 31st day, making it official if there is zero response from the FDA
Yes....am hoping for July 26, Friday, but Monday July 29 is a more realistic date considering it would be a Monday.....and one heck of a Monday it might be.
I suppose it could be next week too. Who knows? At least we have seen no followup questions/clarifications from the FDA yet.
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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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