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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.
From persons involved with getting the positing filled.
New person should be starting this coming week. Internal fill of position who has long history with Vivos and good tech background. Be interesting to see what this persons style/impact will be.
Excellent post!! Spot on assessment of one particular poster and their personal vendetta to keep Vivos and RDGL down. We longs have known this long time. There’s nothing “objective” about the posters intent. Once IDE submission is announced then approval, the positive news and market action will be such overwhelming force, the poster will move on,
Great postings Chereb!!! Keep it up! $RDGL
You got that right! BDD! IDE submission then IDE approval. Start clinical trials and successful phase 1. Going to be an epic 2024! $RDGL
Put the FUDster on ignore. It works wonders.
Correct. The guidance path Vivos has been on with FDA for the IDE application process and now with the recent BDD makes me more confident than ever Vivos will get IDE approval.
100%. Initial fun starts with IDE submission. Real fireworks happen with IDE approval and start of clinical trials. I expect they have a lot of other News also they’re holding back until IDE approval.
Unlikely given they’re probably finishing testing and then write up summary. Submission more probable for later February or early March. But who knows, they could surprise us.
Amazing how effective the ignore function is here. Better than a phone block on my ex lol.
Correct. As prestigious as Mayo is, it’s something not done on regular basis. Says a lot about MK and Vivos.
It shows how much confidence the Mayo clinic has in Dr Korenko and vivos and IDE approval so they can start clinical trials.
Yessir! Going to be an awesome 2024. IDE submission, then approval, then start clinical trials. $RDGL
The fact that BDD was granted so close to IDE submission bodes well for approval imo.
Agree. Put the FUDster on ignore.
Ignore his posts and replies and rest should take care of itself. Majority of posts were in response to his FUD.