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Easy to say when you’re on the sidelines with no skin in the game. Always chiming after the fact. Hilarious. Wish i had those 500k shares!
How many shares you got Konshe?
Congrats to the person who got the 500K bid fill. That will pay off handsomely! $RDGL
Good stuff being posted here. Hopefully next monthly update provides more details on this.
Semantics. 1 new position. 1 replacement. I’d still consider them both new hires.
At the end of the day, only thing that matters is IDE approval. I would rather MK methodically complete every step and task requested and required by FDA to ensure once IDE is submitted, it’s a for sure slam dunk approval. If it means waiting until June, I can wait. I have a huge $ stake here.
Ya, June is more realistic for submission.
At least we have more of a time line now. Looking for late April or May for submission.
Having been involved with RDGL since MK became CEO, he’s been very frugal and tight with money and almost adverse to having any type of marketing plan as that would only siphon money away from more urgent needs. The fact that he’s hired two full time employees for marketing says a lot. Tells me he’s fully expecting IDE approval, it’s close, and he’s ready to start a marketing plan.
Yup! And the fact they finally hired a marketing team, tells me MK is even more confident of IDE approval and wants them in place now.
This I agree. I don’t think there is much free liberty for SMM team to post whatever. They get approval from MK or told what to post. Which is fine.
I don’t think MK will ever give a definitive timeline or anything that will give an expected date for submitting IDE anymore. With FDA calling all the shots, he’s at their mercy and so doesn’t want to give a date then have FDA move the goal post further out again.
Good post!
Ya, IDE submission and approval is the only target investors interested in at the moment and they way things have been, don’t see MK giving any submission updates, timeline etc, that could pain him into a corner when FDA controls the game.
Exactly. 95% chance of winning. Just a matter of when they announce the drawing lol.
Agree. With company not giving any clear signals as to when IDE submission is expected, and investors, current and potential, not knowing how much further submission will get pushed down the road, the share price is reflecting the mood currently. Longs are holding with few buying, swings who got in a while ago expecting to play a surge in sp are selling along with MMs driving down the sp.
Reality is longs are tapped out and not adding much more, if any. There’s not any new/interested followers buying based on anemic volume. Everything and everyone is sitting back waiting for IDE submission. Meanwhile, MMs and impatient swing traders are selling and slowing moving price down. Until news of submission, we hold in the 5s/low 6s.
Only thing it cost was employee time. Gripe if they don’t put up the website. Gripe when they do. Pathetic.
The new website, IsoPet.com is active. Should be fully ready Feb 1.
John closed shop, terminated his X account, and is enjoying the good life in the Cayman Islands. What a scam that was.
Smart investors continue to add at these price levels when they can.
That happens when a swing trader becomes a long. 300K shares will be worth more post IDE approval than selling at $0.07.
Not really numbnuts. Last update was new person would start in a couple weeks. Turns out start date is Feb 1.
Just you. New to the party?
Yup! Let the marketing/social media campaign begin!!
Yup I stand corrected. New person doesn’t start until Feb 1.
Management wanted someone from inside the company.
Old PR. She’s no longer involved.
Grab a clue genius. She’s not the PR person.
No she’s not. Cam’s wife was temporary until the position was filled just recently with person internal with Vivos.
“…the submission often needs to include comprehensive information about the device. This typically includes details about how users (healthcare professionals, patients, or caregivers) will be trained to use the device safely and effectively.”
I would expect Korenko and team have the “Instruction/User manual” already completed. Especially given the process needed to certify vet clinics as well as train personnel to administer the material. Not much of jump to change some wording etc for human use.
The certification training for human therapy is the same type of training vet staff do for using the device and working with radioactive material.
That being said, until Vivos and the new PR guy clarify things, it’s a waiting game for… it happens when it happens.
Agree. Not sure if it’s just poor PR or they’re intentionally being vague. They really should clarify their updates.
Appears based on their statement that they are completing final TRAINING certification steps for human therapy.
———
“The update said that this quarter they will "complete the final training certification steps for human therapy."
The steps are being completed...training is not being completed.
Meaning they are finalizing the process which they will use to certify people to treat humans with radiogel, not certifying any person to use radiogel.”
I wouldn’t be surprised if they haven’t started the 2nd phase already, even in conjunction with running the phase 1 test. The updated only said completed phase 1. Obviously just speculation on my part but again don’t see MK starting certification training until assured of IDE approval.
Yup. Anymore trying to guess is pointless. I’ve no doubt it will happen, and still think submission before they start certification training.
Same question about the certification training. It’s why I still think they do submission and get approval before they go to time and expense of the certification training.
Grab more while you can!
lol I know. Not to insightful. However I’d ignore the noise of those saying this recent update about completing training next quarter means Vivos won’t submit IDE until then.
The previous update they already stated after they receive FDA approval to conduct clinical trials, they would complete final training for certification.
Here is part of the previous update, they posted.
“…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.
So as I expect the last of the animal testing has been completed, final data write up and then IDE submission should be before end of Q1. JMHO.
Catfish
Free account. Don’t have PM.
As all testing should be finished by now I think we have rounded third base and headed home. Let see what else gets posted on X this week. My guess, before end of Q1.
No, training certification is the training for staff conducting the clinical trials to be able to handle and administer radioactive materials.
Just saw this post on X that answers your question.
No. The training certificate is not needed for the IDE submission. Vivos can submit IDE prior to training certification being completed. Training certification is what’s needed to start human clinical trials. Staff doing trials has to be trained and certified to handle…
— Alpha167🇺🇸Christ is King ✝️ (@ClearUTL) January 23, 2024
Greeting TWG! Welcome to the circus.
Agree, 2024 will be a monumental and epic year for Vivos and $RDGL. The recent BDD was a nice confirmation of FDA satisfaction with the IDE process taken by Vivos and data submitted to date and gives me even more confidence of IDE approval to move forward with clinical trials.