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Mayo Clinic Training With Radiogel is Complete.
Another step closer.... #MayoClinic #NewGeneration #CancerTreatment #CancerAwareness #Cancer #RadioGel #VivosIncUSA #IsoPet $RDGL pic.twitter.com/tXttdLIHCp
— Vivos Inc. (@VivosIncUSA) April 10, 2024
Yeah i heard the IDE second quarter submission that Doc supposedly been lying about is taking place soon. Or at least what few on here claim won't happen.
Our time has come.
I'll vouch with 100% accuracy your statement is credible. Matter of fact, I also received a similar response. Sorry glo-stick, I'm not into show and tell.
RDGL
Merry Christmas Everyone!!
Safe travels!
And Korenko is worth every cent those shares produce and then some.
Right its not. But if they apply for a IDE and its denied, you wont have to worry about getting wet in a pool, cuz there might not be one.
I have not a clue what Docs plans are. If he has 100% confidence in approval, then sure, let us know when they submit. But we all know how FDA works for small Pharma's.
Doc just did it with BDD. Why not with IDE?
Not worried at all. This ticker is made for longs not day traders. Not sure if Doc will announce IDE submission, but if he does announce, guess who jumps in and rides up to IDE decision then jumps out?
I myself would like to see RDGL trade-up organically on its value per the market strength, and not from a bunch of day traders. So I'm good if Doc surprises us all with a IDE approval PR.
It is 100% true.
How does the FDA Decide Whether to Grant a Breakthrough Device Designation Request?
What is the FDA guidance on breakthrough device designations? The FDA has a rigorous process to ensure the safety and efficacy of medical breakthroughs, including a thorough review of applications of breakthrough technologies. The FDA looks at the scientific data and patient outcomes when submitting an application that weighs potential advantages over existing treatments available to patients. A breakthrough device designation carries with it special priority reviews, intense guidance, and urgency when remediating any issues. Through the Breakthrough Devices Program, the FDA can grant designations for those devices that can offer significant improvement compared to existing treatment options for individuals in need – ensuring each patient receives the best care possible.
FDA breakthrough device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis
What are the Benefits of the FDA Breakthrough Devices Program?
Breakthrough device designation from the FDA can provide a vast array of benefits to medical device companies as well as patients in need. For medical device companies, having your product on the breakthrough device designation list expedites regulatory processes, providing a fast track to FDA interactions and accelerated reviews that bring life-saving devices to market sooner than the standard submission route. The expedited review for breakthrough medical devices results in faster and more efficient development timelines. From a patient’s standpoint, providing treatments and technologies that could help in ways previously felt unreachable can drastically improve the lives of countless individuals
Starting BO bid is $5 billion. Know what you own.
Mods, another great post to be stickied Please.
Radiogel.com
Thank you!
Well done Radiogel investors. Let today's news and future news be a warning to all that the Doc is in full force in getting Radiogel into humans asap.
Delete old post and refresh your browser.
Ok, get back in and when it asks for a post number enter tthis number and hit ok or submit. 168787
If you already have a post up, you need to take old one down first.
The goal of FDA Breakthrough Devices Program is to get potentially life-saving or life-improving innovative medical technologies into the hands of patients and healthcare providers faster.
These are called Sprint Discussions
Sprint discussions are a series of discussions held on a specific topic within the time period set by the sponsor (aka you). These discussions allow for rapid and repeated interactions with FDA about a single topic. Because FDA hopes to engage with breakthrough device designees early and often, the goal of sprint discussions is to reach an agreement in a shorter time frame than would occur by a typical pre-submission process.
MODS!!!! Please sticky this post.
Or take yourself off mod position and let someone else do it.
Congratulations y'all for sticking it out and not listening to the constant bile put out by the 3 stooges. Todays news is bigger then you think. So hold tight.
MERRY CHRISTMAS!!
And #5 is not a IDE issue but a huge bonus if it does work.
Number 4 is all on Mayo Clinic. And I believe it is completed. After FDA green lights Radiogel then Mayo Clinic will be up to speed and ready for first in human treatment.
Vivos lost one of their good one's. Its going be tough to replace his media talent. R.I.P Cam.
And "Next" quarter for full dress rehearsal means October 1st to December 31 2023. So its happening now or complete.
They won't need to have another face to face meeting. They'll write report, then submit possibly in January or February.
"Failed to repond" that's another lie.
Thats 252 Pinocchio's
Im hoping they sign him to a 10 year contract.
I see a end in sight. Plain as day.
I don't expect another meeting. Reread my post...but do it slower this time.
And all other FDA meeting were a success.
.
All prior FDA meetings were expected. Your statement is untruthful. I got you at 251 Pinocchio's
There not steps....there many hurdles.
Thats not the case. Your opinion
That is key, Government one way or another could hold us up. Again....
I think we are already being invaded.
I don't think there will be another face to face FDA meeting. When report is written and reviewed, they submit report to FDA. FDA reviews report and possibly will do a texted Q an A with Doc and team. If all is good, we should know in 30 days or less.
Last quarter means (April 1 to June 30th, 2023)
This quarter means (July 1 to September 30th, 2023)
Next quarter (or last) meant (October 1 thru December, 31th 2023)
Next year means (2024)
Submittal of the IDE - (Q211938/S001)
Our next IDE application will be an amendment to the previous submittal. We are systematically preparing the answers to the 60 previous FDA comments. And as we near completion we felt it was worth the investment to redo a few studies to ensure that the FDA comments are fully addressed. This includes the polymer and hydrogel shelf-lives, the effect of radiation on the hydrogel, and the effect of polymer freeze-thaw cycles on the hydrogel properties. These tests will be completed next quarter (Q4).
VX-2/Rabbit Animal Study - Dr. Rebecca Krimins has treated 12 rabbits. Next quarter she will treat the last nine rabbits, submit the data to Pearl Pathways for independent review, and write the report.
Genotoxicity – Based on the FDA recommendation; on September 29th we participated in the Pre-Sub meeting to discuss the Genotoxicty Chemical Characterization Protocol (GCCP). We now feel sufficiently confident to initiate the genotox testing next month (October–November 2023).
Animal Therapy Marketing
Marketing to pet parents, clinic owners, veterinarians, and oncologists is complex. Aside from utilizing advertisements in key journals and the social media, the following activities are important:
1. Open new small animal and equine clinics that are reasonably close for pet parents to access.
a. This quarter we certified a new small animal clinic, Indian Creek Veterinary Hospital in Fort Wayne IN, and two new equine clinics, Myhre Equine Clinic in Rochester NH and Hopkinton Animal Hospital in Weare NH.
b. We are currently in contact with several other clinics.
2. Participate in conferences to interface with the animal therapy community.
a. Last Quarter
VSPA Spring Conference in Saint Paul MN
American College of Veterinary Internal Medicine, ACVIM in Philadelphia PA
b. This Quarter
11th International Conference on Isotopes in Saskatoon Canada
Nigel Stevenson from Exubrion Therapeutics® and I presented a joint paper entitled “Precision Radionuclide Therapy for Treating Veterinary Cancerous Tumors and Osteoarthritis.”
Washington State Veterinary Medical Association, WSVMA in Tacoma WA
c. Next Quarter
Veterinary Cancer Society, VCS in Reno NV
American Association of Equine Practitioners, AAEP in San Diego CA
d. Next Year
American College of Veterinary Internal Medicine, ACVIM in Minneapolis MN
American Association of Equine Practitioners, AAEP in Orlando FL.
International Radiation Protection Association (IRPA) and IRPA 16th International Congress and 69th Health Physics Society Annual Meeting in Orlando FL
Dr. Darrell Fisher submitted an abstract: “Direct Interstitial Injection: An Approach to Optimizing Therapeutic Ratios for Safe and Effective Delivery of High-dose Radionuclide Therapy in Treating Solid Tumors”
– Darrell R. Fisher, Versant Medical Physics and Radiation Safety; Michael K. Korenko, Vivos, Inc.
3. Perform animal studies that result in publications in key journals.
a. Next quarter we will complete the VX2 tumor injection at Johns Hopkins Veterinary Clinical Trial Network within the approved IUCUC protocol. This will result in two publications.
b. Next year we intend to follow-up with a new small animal study at JHU and an equine study at a university located near “equine territory.”
c. Longer term we will conduct other studies using mice models to support future indications for use, such as lung cancer.
4. Next quarter Dr. Bill Bradly, owner of the New England Equine Practice, will conduct an experiment to determine if IsoPet is effective in treating caudal heel pain syndrome, sometimes called navicular syndrome. This is a complex syndrome, but if IsoPet is effective, this is a new and large market.
Hope this clears it up.
Medical Business Sector
Submittal of the IDE - (Q211938/S001)
Our next IDE application will be an amendment to the previous submittal. We are systematically preparing the answers to the 60 previous FDA comments. And as we near completion we felt it was worth the investment to redo a few studies to ensure that the FDA comments are fully addressed. This includes the polymer and hydrogel shelf-lives, the effect of radiation on the hydrogel, and the effect of polymer freeze-thaw cycles on the hydrogel properties. These tests will be completed next quarter (Q4).
Important content is the VX2 Tumor Animal Study report and executing the Genotox protocol:
VX-2/Rabbit Animal Study - Dr. Rebecca Krimins has treated 12 rabbits. Next quarter she will treat the last nine rabbits, submit the data to Pearl Pathways for independent review, and write the report.
Genotoxicity – Based on the FDA recommendation; on September 29th we participated in the Pre-Sub meeting to discuss the Genotoxicty Chemical Characterization Protocol (GCCP). We now feel sufficiently confident to initiate the genotox testing next month (October–November 2023).
Mayo Clinic Protocol and Institutional Review Board (IRB)
After receiving FDA approval to conduct clinical trials we need formal approval from the Mayo Clinic IRB. In anticipation of this step and to help expedite the proccess we have submitted the Clinical Trial Protocol to their “gatekeeper” for comments. We have also been conducting certification training for Dr. Paz Fumagalli. Next quarter we are planning to complete the final training certification step using high activity RadioGel™ in a full-dress rehearsal operating theater.
Animal Therapy Marketing
Marketing to pet parents, clinic owners, veterinarians, and oncologists is complex. Aside from utilizing advertisements in key journals and the social media, the following activities are important:
1. Open new small animal and equine clinics that are reasonably close for pet parents to access.
a. This quarter we certified a new small animal clinic, Indian Creek Veterinary Hospital in Fort Wayne IN, and two new equine clinics, Myhre Equine Clinic in Rochester NH and Hopkinton Animal Hospital in Weare NH.
b. We are currently in contact with several other clinics.
2. Participate in conferences to interface with the animal therapy community.
a. Last Quarter
VSPA Spring Conference in Saint Paul MN
American College of Veterinary Internal Medicine, ACVIM in Philadelphia PA
b. This Quarter
11th International Conference on Isotopes in Saskatoon Canada
Nigel Stevenson from Exubrion Therapeutics® and I presented a joint paper entitled “Precision Radionuclide Therapy for Treating Veterinary Cancerous Tumors and Osteoarthritis.”
Washington State Veterinary Medical Association, WSVMA in Tacoma WA
c. Next Quarter
Veterinary Cancer Society, VCS in Reno NV
American Association of Equine Practitioners, AAEP in San Diego CA
d. Next Year
American College of Veterinary Internal Medicine, ACVIM in Minneapolis MN
American Association of Equine Practitioners, AAEP in Orlando FL.
International Radiation Protection Association (IRPA) and IRPA 16th International Congress and 69th Health Physics Society Annual Meeting in Orlando FL
Dr. Darrell Fisher submitted an abstract: “Direct Interstitial Injection: An Approach to Optimizing Therapeutic Ratios for Safe and Effective Delivery of High-dose Radionuclide Therapy in Treating Solid Tumors”
– Darrell R. Fisher, Versant Medical Physics and Radiation Safety; Michael K. Korenko, Vivos, Inc.
3. Perform animal studies that result in publications in key journals.
a. Next quarter we will complete the VX2 tumor injection at Johns Hopkins Veterinary Clinical Trial Network within the approved IUCUC protocol. This will result in two publications.
b. Next year we intend to follow-up with a new small animal study at JHU and an equine study at a university located near “equine territory.”
c. Longer term we will conduct other studies using mice models to support future indications for use, such as lung cancer.
4. Next quarter Dr. Bill Bradly, owner of the New England Equine Practice, will conduct an experiment to determine if IsoPet is effective in treating caudal heel pain syndrome, sometimes called navicular syndrome. This is a complex syndrome, but if IsoPet is effective, this is a new and large market.
Yttrium-90 Cost ReductionsYttrium-90 Cost Reductions
After working with the Eckert & Ziegler senior management team in the US we will now obtain the Y-90 from their Wilmington MA plant to reduce shipping costs. The new Y-90 price will result in an approximate $1,000 decrease per therapy. Germany will remain as an alternate source of Y-90.
Later this year we intend to demonstrate our enhanced production flow and perform verification testing to qualify the new source of Y-90 as required by our quality management system.