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Vivos Inc met with the Food and Drug Administration to obtain suggestions on improving the current draft of the Investigational Device Exemption, which is necessary to initiate clinical testing in humans. Two physicians from Mayo Clinic, Dr. Paz Fumagalli and Dr. Beau Toskich did an excellent job presenting the need for Radiogel™ to treat recurrent thyroid cancer and to answer a range of questions from the new FDA review team.
The FDA was very supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo protocol for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call dedicated to the details of the dosimetry calculations.
Mike Korenko stated “Obtaining FDA approval is challenging, but we made significant progress with this meeting. This was the first time the Mayo Clinic Doctors met with the FDA regarding RadioGel. They were able to communicate the unmet medical need that RadioGel could address and successfully fielded several key questions from the FDA reviewers. If we did not take this interim step our IDE submittal would likely have been rejected and it would have cost us significantly more effort and time to recover. We already have sufficient funding in hand to complete all the scope necessary to submit the final IDE.”
Buyout potential
News about the benefits of #IsoPet® Precision Radionuclide Therapy is spreading across the globe. Here, a German Vet is sharing our treatment on his website.
While IsoPet® is not currently available in #Europe, we’re working towards that milestone.
I’d prefer a monthly update with great news and then mid January a recap with additional good news. Keep the train moving, don’t drop it all at once and let the sp stair step
Hope we start the new year with a hammer drop of a monthly update. Get the year started off with a bang
Up over 20% in last month
It's beginning to look a lot like Christmas!??Coming soon.??Our new corporate website will feature detailed Investor & Industry information. Our RadioGel™ | IsoPet® website will focus on providing information regarding the medical devices' benefits to patients.$RDGL #cancer pic.twitter.com/kYx5gYP4Bg
— Vivos Inc. (@VivosIncCo) December 6, 2022
Another tweet letting us all know we are not in the game yet and others are.
Cashing in about half shares at .75, letting the rest ride for approval and getting into phase 1 and 2
1 here
I’d like to think so but buying in at only 120k shares ish is not a tell for me. Happy to see the confidence either way
Your opinion is wrong and falsely misrepresents all facts
Thanks rtg
You just answered your own question by the Y90 having significant short half lives. Therefore at worst case with minimal leakage half life is exhausted. To include the suspension gels reducing leakage further unlike seeds or other brachytherapy options
You mention profitability but fail to realize the possibility of rdgl getting to a buyout scenario which is very likely
All the more reason to get rdgl to market
Guess that would depend if the December 1 update is a tweet monthly update or meaty and turned into a December 1 PR
While I do like him buying more shares unfortunately I also know he gets paid a lot each year from the offerings. With that said if taking a percentage of pay to buy shares calms other investors then he is very smart to do so. However this can also be seen as prolonging other more negative motives if they exist. I sure hope for all of us that’s not the case
We can sit on this board a lean left or lean right on our opinions but from a long enough eventually becomes enough. MK needs to make big moves soon. This can’t drag on forever. It’s long overdue to see this company in action or to call it quits.
After approval $5 plus
Drop. that’s nothing
Facts are facts
Agreed, I think this is just a normal monthly update with maybe some nuggets of positive movements. Tweet worthy doubt pr worthy. Could be wrong but that’s my opinion.
Just buy more if you can and hold. No need to put pressure on tomorrows news. Progress is being made
Only longs accumulating and holding will tighten the reigns of what’s inevitable
Again wasn’t a failed BDD. You are entitled to your own opinion but just repeating a word “failure” doesn’t make your opinion of repeating the word factual.
BDD was never rejected, denied, or not approved. Big difference in how you are spreading the word failed.
For sure
It’s a 12.5% bargain @0.07 given the offering is at 0.08
Agreed
Agreed. Old one resubmitted to fill remaining offering
Yeah all that was previous 10-q all of that has already been said in the past. Need knew information
I could be wrong but why submit an offering now just prior to the Nov 1 news? If the news was good price go up and offering would be higher but instead it’s locked at 0.08.
Check my last post or two see link
Same offering as before it looks like. Better be some good ass news on November 1
In preparation for fda approval to fund the companies ability to conduct phase 1. The company will need funding every year until profitability changes. Therefore I believe this circular is about getting qualified for the same offering as before
https://sec.report/Document/0001493152-22-027447/
I do not know specifics. But optics of this happening at the level it’s happening all but assures it’s happening all over at less observes levels
Anything under .12 is a steal. Under .18 is ok. Everything else thereafter is profit obtainable depending on when you get in for the ride up
Just last week dozens got caught in multiple government agencies tied to companies and insider info
Based on historical past cancer can’t be cured either but we still try.