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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.
Hydrogel Cost Reduction and Optimization
We enhanced the polymer production process by eliminating a carbon filtering step. We also ran a dozen production runs to scale up the polymer production volume and to understand and reduce variables for reproducibility. All changes were supported by validation testing.
In parallel, we were analyzing the PET data from the VX2 animal testing to determine if we can enhance the IsoPet characteristics while remaining within specifications. We increased the standard polymer concentration in IsoPet hydrogel. The improved product has a lower gelation initiation temperature and greater strength to help lock in the phosphate particles.
Alternate Production Site
IsoTherapeutics is our primary manufacturing contractor for our hydrogel and particle components, but from a risk mitigation perspective we are to establishing an additional supplier. For almost two years we have been working with Jay Simon, the GM for North America, for Eckert & Ziegler to be our alternate. They engaged in detailed discussions of our proprietary procedures and have visited our production site, and we are confident a supply agreement can be established
Quality Management System
We have created a robust Quality Management System. This includes documents, GLP validations, and GLP test plans and reports. This is necessary to prepare for FDA audits that occur when we initiate human clinic studies
Intellectual Property
Intellectual property remains a priority.
Patents
The provisional patent on the chiller and related equipment expires on 12/30/23 so we authorized Indiano Law Group to file for a utility patent based on the chiller, but including the combined shipping pig/vial holder and syringe shield. Chances are good that the patent office will force us to split in early 2025. At that time, we can prosecute the two or three applications serially.
We received notification that Patent Number 2023/0263913 A1 Radiotherapy Gel and Method of Preparing the Same was published on 8/24/23.
We authorized our patent attorneys to file (nationalize) our hydrogel patent in each PCT country in February for Application: RADIOTHERAPY GEL AND METHOD OF PREPARING THE SAME - International Application No. PCT/US2022/43274. This will cover more than ten patent offices that collectively cover 63 countries throughout the world.
Trademark
We filed for a trademark on the term “Precision Radionuclide Therapy” so we can now use the TM mark.
The real question is why do you care if someone says soon? Its their preference and believe in thier stock they own. Their not out calling CEO a liar, incompetent, serial liar, and repeating calling for the CEO to go. If you were a true investor (which im sure your not) you would question his 3000 repeated post. But then again.....I know who your are and you wont.
Why do you give crap to a poster that says "soon" a lot but you ignore a poster that uses the word "liar" in every post? Hmmm!
Never mind.....I already know the answer.
Great analogy and spot on true.
https://www.radiogel.com/
Mayo Clinic is on high IDE alert. When FDA approved they'll perform the first ever Papillary thyroid cancer injections using Radiogel. Fact!
Confirmed by one not by the other 3000 investors. So nothing to worry about here.
Be careful what we wish for right?
We have MMs on this board. Plain and with peanuts or long or with shorters.
Dont worry about it and just do it. It's your job.
There are 3000 (minus 3) RDGL investors that beg to differ.
Just take us down to 3s or 4s, im not done Christmas shopping.
Fact!
Michael K. Korenko, Sc.D.
President • CEO Vivos, Inc.
Mike Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defence.
He currently is the author of 28 patents and has received many awards, including the National Energy Resources Organization Research and Development Award, the U.S. Steelworkers Award for Excellence in Promoting Safety, and the Westinghouse Total Quality Award for Performance Manager of the Year.
Dr. Korenko served as Vice-President of Westinghouse Hanford, Executive Vice President of Closure at Rocky Flats and Chief Operating Officer for Curtiss-Wright Electro-Mechanical Division producer of the nuclear components for all the United States submarines and aircraft carriers and for commercial nuclear power reactors.
He is currently CEO and President of Vivos Inc. developing yttrium-90 brachytherapy for animals and humans.