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There is a flight plan if the covid pill and Adva27 are to pass testing and be manufactured. Some things are bigger than just making money sometimes and this is one of them for people with cancer everywhere. Ive been buying more down here. $SBFM
Some good follow through tomorrow taking SBFM to settle above the 200 dma on a yearly at .1315 would be a confirmation signal a run has began. The company should wait to put out any news until the price is alot higher .30-.50 than put out the news to take it $2.00 and higher before the rs. $SBFM
Good advice jimesica. If the chameleon lets the UoG news out before an r/s (like he should, but probably won’t and he will blame it on Aegis) it is good to know the number of shares at 5m they will use to dilute into the news- the mm ASCM started back up a week ago on the ask and is a known diluter. They are probably paying the new Director’s salaries with the 5 million they get from the dilution which they did not think of doing ahead of time. The doctor did not have enough funding years past but now they have it. the company should spread the news out daily to maintain the run and see the price the news takes it. $SBFM
Thanks War for your insights. I hope you are right for all investors. A good rule applies here- only invest what someone can afford to lose. byoc
imo the ceo stock options will be protected from an r/s making the common shares for his salary that are not protected insignificant and imo he knows this already its just more smoke and mirrors like otcx is doing. Maybe not.
The ceo receiving his pay in common shares may look like a good gesture upfront but if he owns stock options whats the difference to him?
Backed up the trucks again today. A Thanksgiving IDE approval for FDA clinical trials using Radiogel will be good progress toward a Pivotal Study. Getting NIH funding would be as well. Lots of catalysts with RDGL. Time to run! $RDGL
Excellent post War! As a best practice keep an eye on vwap to identify what price the market makers will trend the stock back to when there are huge spreads in the market. Market makers want to get the price back to vwap and in doing so they use sophisticated algorithms that determine the vwap pricing.
RDGL did write “Certain First in Human Studies” in the 10Q (p30) meaning it will be discussed as being a part of their EFS IDE in the Nov 30th meeting with FDA. $RDGL
Yes, although a smaller clinical trial study the approval of an EFS IDE answers many questions and is just the same FDA process as a Traditional IDE.. its a very good indicator of further FDA approvals for more studies moving forward such as a Traditional IDE. imo the run starts now. Say goodbye to .10s.
$RDGL
“In the IDE submission, the study should be clearly identified as an EFS. Since the EFS is a small study (limited number of patients and sites), it does not require registration on www.ClinicalTrials.gov.”
Looks like the info will be coming directly from the company due to the EFS IDE being a smaller clinical trial study. Thanksgiving surprise! $RDGL
https://mdic.org/wp-content/uploads/2018/12/MDIC-EFS-Blueprint-for-EFS-Success-2016.pdf
According to the following PR by the company they submitted the EFS IDE presubmission by Sept 20- imo according to step 4 of the EFS IDE process (p25- see link below) it can take up to 60 days from the presubmission date (Sept. 20th-pr below) for EFS IDE approval which would put the date at Nov. 20th and so there is the meeting scheduled for Nov 30th. imo they know now unofficially due to the website update with clinical trials tab. $RDGL
Sept PR:
Richland WA, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. is pleased to announce that it has submitted the IDE, Investigational Device Exemption for The Early Feasibility Medical Device Study, First in Human Study for Y-90 RadioGel™, to the Food and Drug Administration as part of a pre-submission meeting process. The FDA recommended this path to facilitate enhanced ongoing communication with Vivos and to increase the efficiency of the review process. This review typically takes several iterations and we will continue with biocompatibility testing in parallel.”
Step 4: EFS IDE Submission
“Once the interactive pre-submission is complete and your data package is complete, it is time to assemble your IDE. Essentially, the format and content of the IDE is no different than a traditional IDE in its requirements. First and foremost, be respectful of the review team at the agency. Also, establish good communication process with the review team at FDA. It is important to plan ahead to avoid any surprises.
Once submitted, the IDE goes through a 30-day review cycle. Since the 30-day review period is highly interactive, ensure your team is ready and available. This is critical for small companies operating with limited resources. It is likely that questions will come from FDA with a request for a quick turnaround. Another benefit of the interactive review is that you have a better chance of getting clarity on ambiguous questions preventing the back and forth that can commonly occur delaying the regulatory process.
After the IDE has been approved and the EFS has started, be sure to continue the interactions with FDA. Changes to the device design and/or materials, procedure, protocol, instructions, and even patient population are to be expected in an EFS, and
Disclaimer: This blueprint is not policy or guidance. Readers should also consult relevant FDA guidance.
MDIC | 25
you will minimize the risk of regulatory delays by maintaining the interactions and promptly resolving issues as they come up.
With the completion of the EFS, several scenarios are possible. The Sponsor/Innovator may elect to expand the EFS to add additional patients if changes in the device design or the procedure occurred in the initial EFS and additional information is required to finalize the design. Alternatively, the Sponsor may decide that the design of the device is near-final or final and that enough information is available to perform a traditional feasibility study or even a pivotal study.”
https://mdic.org/wp-content/uploads/2018/12/MDIC-EFS-Blueprint-for-EFS-Success-2016.pdf
Agreed. Great write up! Cant have an EFS with clinical trials without an approved IDE. Progress! $RDGL
Smart and congrats on your newborn!
my advice would be to stay away from giving her mj gummies with delta 9 thc - not good. Cbd products are good though.
Depends how a person defines approval - moving from an EFS IDE to a Traditional FS IDE is an approval to move to that step within the FDA process. imo you are correct in regard to the traditional IDE submittal and approval- more steps to be implemented first but still great progress is being made here to collect data and move foreword. $RDGL
Yes, clinical trials in humans can only happen with an approved IDE according to my research. Looking good here for the next steps whatever they may be. $RDGL
Great write up War! So much to unpack here. I appreciate the insights you bring to BYOC and was there at trip 8s with you but just not as many but enough. 100 million on your part- very nice buys! $BYOC
Interesting take on it, thanks and GLTU
$BYOC
Without the twitter pump BYOC would be sitting at trip 4/5 at this point. Could be a setup for a major dump tomorrow for many who got caught above and a blood bath based on OTCX dilution still occurring.
War, you forgot to say “see you at the top!” $BYOC
Last take on it for now: current EFS IDE > clearance on FDA recommendation into FDA STeP program or Breakthrough Device program (2021) > Traditional Feasibility Study IDE (Jan/Feb 2022) > Traditional IDE submittal and granted (summer/fall 2022) > Pivotal Study (2023 -2024) $RDGL for the win! GLTA
Any informed guesses on how much volume it will take before OTCX back is broken and is off L2 offer side for good due to fulfilling the acquisition and loan requirements and whatever else BYOC is doing with all that dilution?
From what I gathered (correct me if Im wrong) “Early Feasibility” IDE is a study not so much a program as Vivos has not officially entered a FDA program as of yet. I think the FDA program, such as STeP or Breakthrough Device program, still needs to be decided along with the next step study such as traditional Feasibility Study or Pivotal Study. $RDGL
I read “late stage” as in final safety and device design close to completion. If this is true, skip the traditional feasibility study and go straight to the pivotal study under the STeP or Breakthrough Device programs. IMO considering the safety efficacy the device has already shown in animals and the confidence Dr Korenko has expressed in the safety of the device, Battelle and co have probably already behind the scenes tested and retested the device for efficacy on humans in another country before any FDA pivotal studies begin. Too much money involved in this now behind the scenes (and easy enough to test elsewhere in the right conditions) to risk continuing on with FDA to lose millions on a potential denial. $RDGL
Although Vivos was denied the Breakthrough Device “Designation” in its last FDA submittal bid, the FDA could still recommend to Vivos during this EFS IDE to enter into the Breakthrough Device Program based on the latest information it has received from Vivos during the current EFS IDE …like the STeP program, the Breakthrough Device Program speeds up the device to market process due to having more access to the FDA. The FDA did state in its last review of the device “The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your device does meet this criterion because it is a novel application of a brachytherapy device outside of the liver.” A Traditional Feasibility Study or better yet a Pivotal Study under the Breakthrough Device Program or STeP program would be great options considering the device takes only 30 days to kill a lymph node tumor- radiogel would need close attention by the FDA just the same. $RDGL
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program
The results of this EFS IDE and the direction RDGL takes after it will be very telling. Accumulating more data is what Dr Korenko wants..while going through the FDA process in a methodical way (checking all boxes available to get that data. imo partnerships, licensing and a speculative run in sp will occur when the human clinical data pivotal study is fda approved for taking place and is in process collecting more clinical data. Im hoping for the FDA to recommend the STeP program and approve a Pivotal Study as a result of this EFS IDE. RDGL may choose the Traditional Feasibility Study IDE next which is a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. $RDGL
Another program the FDA could recommend to RDGL during this EFS IDE is to participate in the STeP (Safer Technologies Program for Medical Devices) which will allow for more access to the FDA. Having more access to the FDA would help speed up the FDA approval to market process for the device. This is a good option considering the device working on the lymph nodes only takes 30 days to kill a tumor. A traditional feasibility study or pivotal trial while in the STeP program would be advantageous- either way RDGL is going to save lives. Loading. $RDGL
https://www.fda.gov/medical-devices/how-study-and-market-your-device/safer-technologies-program-step-medical-devices
Duly noted.
Dr Korenko in this audio says Radiogel is choosing to concentrate its current filings based on treating the lymph nodes and not skin cancer due to it only taking 30 days to show Radiogel has killed the tumor and therefore making it a faster clinical trial approval process leading the way to more FDA approvals for the use of Radiogel in other areas. As well, he says once the FDA gives an approval of the IDE due to the clinical data it has received in the IDE process, the company actively has licensing and partnerships in process to move forward.
https://www.webcaster4.com/Player/Index?webcastId=36586&g=c7311028-4080-46b8-8a94-50747fd819a4&uid=6060072&sid=
The design changes to the device should be already communicated to the FDA and in the final stages if not completed at this point with this current EFS. imo its now about the clinical data on file and the Mayo Clinic and their 3 doctors on staff working with RDGL and Dr Korenko justifying the on file clinical data presented and recommending to the FDA which FDA Authorized study is next. RDGL is getting their monies worth with this EFS as “an EFS in the U.S. is required to follow the same regulations as pivotal studies. pivotal studies are performed with a final device design.” The doctor is the conservative type taking all the next steps offered by the FDA in order to increase data efficacy. I think he chooses to forego a pivotal study next and move forward from the current Early Feasibility Study > Traditional Feasibility Study next in order to to play it safe and collect more clinical data within a smaller pool size. unless the Mayo Clinic recommends to go from the current EFS > the Pivotal Study next based on the clinical data it has already garnered and to increase the pool size of patients in the next study to move faster to market. A pivotal study would be a vote of confidence by the Mayo Clinic and FDA but either of these studies will suffice. Although more submissions slows the process down some, its all about the data and having patience with Korenko. $RDGL
https://medinstitute.com/blog/how-does-an-early-feasibility-study-differ-from-a-pivotal-study/
https://www.fda.gov/files/medical%20devices/published/EFS-FAQs.pdf
nice call JACKPOT!
OTC QB status with Shell Risk still listed on the OTC website. Looks like the otc needs to make some more updates but in any case this is progress! $GSTC
They have the means now to pick up a company that can help them with that data such as an AI company
If they are stopping on an even number we got 2b to go. That would take us to 6-7 range next week Monday or Tuesday. Guesses on how big the acquisition will be with the amount of dilution they are doing?
hopefully the old otc trick in going for QB status (while behind the curtain knowing bad old financing deals and lack of transparency may certainly disqualify them from approval) and dilute into it did not take place with GSTC. The co is still listed on the otc website as shell risk status- easily removed with only a letter to otc markets by the ceo.
Bb been very helpful to this board and its great to have him here and communicating about GSTC. Jimbo has already said he is going to dilute some but not much. The right steps are being taken but it is going to take patience. They could take the Shell Risk off the OTC page with a simple letter to the OTC, may help get some new buyers. I hope the FDA takes into account the Italian data on file and speeds up the approval process. $GSTC
Yes, more to be revealed here. $RDGL
The same phone # is listed on the top of the FORW home page.
https://www.forwardlyplaced.com/
The phone # in the upper left corner is the Forwardly management phone number.