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…because IsoPet has the potential to reach blockbuster status. Moose still has four legs and is still cancer free! I don’t know why there isn’t someone dedicated to the IsoPet program. Maybe there is? Signing a deal with Mars Veterinary Health Pet Cancer Care Alliance alone will yield at least $40 million a year in revenue, according to Vivos several years back. They have essentially perfected the product. They had a meeting in late 2022 with the vet consortium. $40 million would go a long way right now. Maybe that is the material news? Unless Dr. K provides a path forward based on the latest FDA feedback, approval will not happen until early next year…maybe. I do not see anything else that would move the needle outside of FDA approval. Only then will I turn my bear into a bull.
If the 400 Gy injection is incorporated in the final VX2 report than the final VX2 report will not be completed until about September or October. Vivos will probably have another meeting after that. No one knows anything about the proposed plan for the genotoxicity comment/recommendation. I do not know how they keep missing things. The IDE was supposed to be submitted summer of 2021. It may be 2024 when this is submitted. Vivos has made amazing progress. Again, Vivos has made amazing progress but way too many errors. They need to get more aggressive with Isopet at this point. One clinic every six months or so and then clinics disappearing after signing an agreement is not enough.
Okay, I look at it from the stand point of a company that ONLY focuses on pets is valued in the dollars. The company was then bought out for at least twice the share price before the announcement based on the company’s POTENTIAL blockbusters…for pets. Lastly, they have yet to make a profit because testing is still ongoing.
It seems like people are so hung up on the IDE that they do not see the BLOCKBUSTER products (two successfully completed pre-clinical tests and all the tests that came before them for one out of three products based off of FDA guidance) right in front of them. I am of the opinion, that at this point, the share price is artificially low because of market sentiment. Not missed deadlines.
Out of my control though. Whatever haha.
The PR on the FDA feedback is really good. There is just so much more to this company and its products.
I don’t know how this isn’t trading in the dollars range.
Providing no timeline and being vague about testing doesn’t sit right with me. Nonetheless, they will not be going bankrupt…and IsoPet. Vet companies are valued in the dollars having not even gone commercial.
Yeah, I agree. I don’t know how it isn’t trading in the dollars at this point.
Nooooo thank you! Haha!
One, I have held a position in this company for almost NINE years. I discovered this board after I started a position. Yeah, I have persevered enough especially under the CEO before Dr. Korenko.
Two, approval sooner rather than later is no doubt better for this company who’s share price, current and future strategic partnerships, and overall success right now is dependent upon IDE approval. Also, market competitors.
Hahaha! I’m still laughing.
A link to Stocktwits with two completely random people talking then…your response! Hahaha!
I agree, this has been a very impressive turnaround for the company. I definitely had my doubts here and there. My history of posts proves that. Again, everything makes sense now. Every move has been brilliant.
The FDA could approve the IDE prior to the 30 days. If Vivos worked with world class FDA consultants, Mayo Clinic reps, completed ONE pre-sub (for the pre-clinical trial plan) AND went through the process for Breakthrough Device Designation (basically a pre-sub) I do not see how the review time could not be shortened. It is POSSIBLE that they could get IDE approval BEFORE 2022. Again, I think that it is POSSIBLE. It is NOT a guarantee. It COULD be another 30-60 days or more if more testing is required.
Again, I agree with you. Vivos is RIGHT there.
Vivos partnered with one of the best FDA consultants in the US for four months just for the pre-submission meeting for the pre-clinical trial plan that took four years to complete. I would be surprised if Vivos DID NOT recruit the same consultants or consultants on a similar level or better. Add in the Mayo Clinic…? 50/50 as I think someone said hahaha!
Your response hahahaha! Funny.
I agree with your assessment Hondo44 AND I agree with Wrinkles. Vivos met all of the requirements explicitly GIVEN to them from the vet consortiums to partner WITH the vet consortiums OVER a year ago. They have only accomplished more feats like the online training, etc. I think that it is only a matter of time.
Vet clinics in Cali, Texas, and Florida in addition to the current ones like JOHN HOPKINS publishing peer-review studies and being fed and getting marketed by vet consortiums is just…wow.
I haven’t been blown away by a PR from Vivos like this ever. John-Freaking-Hopkins…?!!
Hahaha!
Dare I say if news from the pre-sub is more testing is required this news alone would soften the blow.
Vivos was going to work with UC Davis back in 2018 on the prostate and liver cancer indications. Dr. Alice Villalobos is a UC Davis alumna. UC Davis is building that Equine Performance and Rehabilitation Center. Also, they just completed the renewal of their “Comprehensive” cancer designation in October 2021. Why not BOTH? Haha!
I was just saying the same exact thing. I also included California.
Yes. Yes, most of us do know what the pre-submission meeting is about.
You are obviously apart of the few that DO NOT.
I’m rolling on the floor laughing with you too.
“Just” a meeting………..?
NOT a catalyst……….?
CANCEL the meeting…………?
Wowie! LMAO!
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
What…? Whatever. You got this!
Ummmm…yeeeeeeah. You got this!
How do you know with certainty that it is a “flop”?
…but it was an FDA suggestion. Why would Vivos not listen to the FDA? The same organization that Vivos is seeking approval from?
What credibility has he lost? He lost the backing of people that only read the header of a PR?
Did COVID not halt all operations?
POSSIBLE IDE approval August 2021 - February 2022.
I could see why people are frustrated. Vivos should have put “Draft” or “Pre-submission” in the title. “Application” does not mean draft or imply pre-submission. However, the PR explicitly says that the draft IDE is part of a pre-submission process though.
The results of the 30 November meeting could make or break this company. If more testing is required it will be pretty devastating.
FDA plays are ALWAYS VERY RISKY.
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
My apologies.
What do you think the IDE EFS approval is? More pre-clinical studies with animals? You should read the PR again and read about the IDE EFS process. Really good resources posted in this forum. A few months to POSSIBLY get FDA approval in comparison to the last 10-20 years of experimenting and testing is really nothing.
Are you trolling?
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
I’m usually full of questions but everything is as clear as day now. I don’t understand the confusion about the IDE PR from 20 SEP 2021. Amazing news. Why did some people read it as an IDE submission and are now all upset? It clearly says APPLICATION in the header for the PR. It also explicitly says that it is part of a pre-submission process. We have a hard deadline for the IDE meeting as well. Dr. Korenko and his team are a force. Still a VERY risky investment because if the company goes through too many iterations the company could go under.
FDA plays are ALWAYS VERY RISKY.
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
So far I’m on the money.
Hahahaha!!
I saw 72% on “massdevice.com” which is still pretty decent but the article’s link to the FDA source NO longer exists. I do not even know how credible that website is to be honest. That 72% is from 2015. It was at a whopping 15% back in 2011. They reduced the approval time to 30 days (2015) from 422 days (2011). I’m pretty sure that they are BACKLOGGED and will probably ride the Covid excuse and then start jumping on the now impounded Evergreen (joke) haha! Will the numbers go back to 15% with longer wait times of several months, somewhere in the middle, or remain on pace? Very high chance that the aforementioned numbers have taken a dip after the FDA shifted staff resources.
I still do not see how Dr. Korenko and company plan on or are building on previous skin cancer data during a pandemic focused on an indication that is very uncommon in dogs. They conducted the rat spleen demonstration so obviously they need models of some sort. How are they going to get the FDA’s approval to start first-in-human tests?
After years of following Dr. Korenko this seems very uncharacteristic of him. I agree with some folks that IF they swing and whiff on this next attempt sub penny to the R/S possibly.
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
911! News is coming! Haha!
PR references that LC (huge misspell on their VERY FIRST slide haha) Micro 500 briefing when it is convenient.
Dedicated production facility...? March 2021.
May or beginning of the summer...? Beginning of Summer is last week of June/early July. Horse therapy trials are already halted. July/August things should be rolling again...?
I imagine that the Mayo Clinic will not PUBLICLY agree to anything unless IDE is approved.
Cashbox Thomas (TillTom) thoughts?
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
...on conspiracy theories? Like 911 trades and the covid vaccine having lizard DNA in it?
If you google “RDGL stock” the following comes up:
0.099 USD +0.0025 (2.54%)
Closed: Mar 18, 4:32 PM EDT · Disclaimer
After hours 0.083 -0.016 (15.99%)
“After hours.” I see it. It is NOT a glitch. I see it in good ol’ english. Fact. Our realities are not the same obviously.
Educate myself on some spurious nonsense? Noooooope. No thank you but you can proceed in your tin foil hat though.
Hey Till Tom I got one for you riiiiiight here!
Down 16%!!!!
Wait..........NO! I am seeing things CORRECTLY. This ticker is being ravaged in the after hours.
WOAH!
I won’t lie. I was glad to be wrong at first.
Yikes!
Bounce back tomorrow!
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
Glitch on TD Ameritrade. I AM spreading fake news. It is NOT down 14%. I stand by everything else that I said though.
This MAY go lower especially when they start selling shares or just channel in the same price range.
2020 (YES...2020) Objectives: “Completion of [IsoTherapeutic’s] Isolated Production Center”
Over a year off.
IsoTherapeutic’s (most of the time they do not mention who will truly who own it) Isolated Production Center was advertised as coming online March 2021. Then I see a tweet with a generic 2021. NO month.
Okay. Pandemic.
Still a WHOLE year off PRIOR to the pandemic.
Completion won’t move the share price which. It will be a while before there is any serious momentum backed by something of real substance.
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
DOWN 14%.
This MAY go lower especially when they start selling shares or just channel in the same price range.
2020 (YES...2020) Objectives: “Completion of [IsoTherapeutic’s] Isolated Production Center”
Over a year off.
IsoTherapeutic’s (most of the time they do not mention who will truly who own it) Isolated Production Center was advertised as coming online March 2021. Then I see a tweet with a generic 2021. NO month.
Okay. Pandemic.
Still a WHOLE year off PRIOR to the pandemic.
Completion won’t move the share price which, again, closed DOWN 14%. It will be a while before there is any serious momentum backed by something of real substance.
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
Exactly.
Exactly.
Exactly what I have been saying.
It has gotten noticeably inconsistent and not focused.
At one point I could tell when Dr. Korenko was writing the PRs. They were so thorough and lengthy. I enjoyed reading them. He really wrote out his thoughts. It was almost on par with an annual shareholder letter from one of the legendary CEOs. Now they are some short cookie cutter PRs augmented by tweets about cherries after another arguably embarrassing failure.
Still no update on the pre-submission meeting. Which again was supposed to take place FIVE WHOLE MONTHS before the IDE submission. This was BEFORE the indication change. Does that estimate still stand?
POSSIBLE IDE approval (ONE of TWO catalysts that would move the needle on this stock) August 2021 - February 2022.
My apologies, I’m not trying to spread fear.
The Reverse Split (RS) from JUN 2019.
I am NOT saying that a RS is on the horizon.
Again, I am referring to the RS from JUN 2019.
“Proportional adjustments will be made to the exercise prices of the Company's outstanding options and warrants” - 26 JUN 2019.
The price at which the warrants can be sold went from .01 to .08 after the RS. Volume limitations are no more and the shares can be sold as of OCT 2020.
If I am wrong please let me know.
Bottomline, I wouldn’t be surprised to see dilution which seems to always accompany funding for companies at RDGL’s level.
The sellers could be the ones from late 2018?
“All shares to be issued in the private placement are restricted securities. Under the terms of the private placement, the per share purchase price is $.005 per share. The private placement purchasers are also to be issued warrants in an amount equal to 50% of the common shares purchased. The warrants have a two-year term and an exercise price of $.01.” — 20 OCT 2018
Granted after the 1-8 Reverse Split the exercise price goes up to .08...I believe. Public math. Hopefully I am wrong. Correct me if I am wrong. Honestly.
Also, NO volume limitations.
Plus with this upcoming funding...?
.08 being the floor...?
I don’t know. I am thinking lower as in back to 5s...2s...?
SO much is riding on IDE.
POSSIBLE IDE Approval August 2021 - February 2022.
The sellers could be the ones from late 2018?
“All shares to be issued in the private placement are restricted securities. Under the terms of the private placement, the per share purchase price is $.005 per share. The private placement purchasers are also to be issued warrants in an amount equal to 50% of the common shares purchased. The warrants have a two-year term and an exercise price of $.01.” — 20 OCT 2018
Granted after the 1-8 Reverse Split the exercise price goes up to .08...I believe. Public math. Hopefully I am wrong. Correct me if I am wrong. Honestly.
Also, NO volume limitations.
Plus with this upcoming funding...?
.08 being the floor...?
I don’t know. I am thinking lower as in back to 5s...2s...?
SO much is riding on IDE.
POSSIBLE IDE Approval August 2021 - February 2022.
Hard to disagree with a WELL known Basher (Tom...for yeeeeeears haha) when he is ACTUALLY using FACTS.
2020 (YES...2020) Objectives: “Completion of [IsoTherapeutic’s] Isolated Production Center”
Over a year off.
IF they complete IsoTherapeutic’s (most of the time they do not mention who will truly who own it) Isolated Production Center March 2021. Again, most plans have been scrapped or mothballed mostly for good reasons like lack of monies. If even if they complete it will “set the stage” for another stage setter probably haha! I joke kind of but it is truly necessary. It is a foundational piece. It would be even better if it were completely owned by Vivos. Maybe that will happen in the future?
Still no clarity on the pre-submission meeting. Pre-submission meeting for IDE was supposed to happen in November 2021 with a submission in April 2021. Did the BDD process check the box for the presubmission meeting which puts the submission at August? If not when do they anticipate the pre-submission to occur?
Also, I agree with a couple of folks on this board that they should avoid detours like STEP and just simply focus on IDE. Just entertaining the idea is frustrating.
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
Hard to disagree with a WELL known basher (Tom...for yeeeeeears haha) when he is ACTUALLY using FACTS.
2020 (YES...2020) Objectives: “Completion of [IsoTherapeutic’s] Isolated Production Center”
Over a year off.
IF they complete IsoTherapeutic’s (most of the time they do not mention who will truly who own it) Isolated Production Center March 2021. Again, most plans have been scrapped or mothballed mostly for good reasons like lack of monies. If even if they complete it will “set the stage” for another stage setter probably haha! I joke kind of but it is truly necessary. It is a foundational piece. It would be even better if it were completely owned by Vivos. Maybe that will happen in the future?
Still no clarity on the pre-submission meeting. Pre-submission meeting for IDE was supposed to happen in November 2021 with a submission in April 2021. Did the BDD process check the box for the presubmission meeting which puts the submission at August? If not when do they anticipate the pre-submission to occur?
Also, I agree with a couple of folks on this board that they should avoid detours like STEP and just simply focus on IDE. Just entertaining the idea is frustrating.
POSSIBLE IDE approval (ONE of TWO catalysts that would really move the needle on this stock) August 2021 - February 2022.
A lot of MISSTEPS, retracing, retracting, etc. It was all the same: in human testing, robust vet market, partnerships, uplist, etc. Go back over ALL PR and one will see. Very exciting during those times but then you find out through George Sharp that the company was right on the verge of BANKRUPTCY. It would have NEVER crossed my mind. I would have NEVER thought that with the amount of work Dr. Korenko was doing. Then you wonder about TRANSPARENCY.
Recent funding SHOULD INCREASE SHARES outstanding at a price BELOW the CURRENT SHARE PRICE.
Warrant restrictions from two years ago should have been lifted so now they CAN be exercised. Vivos should be issuing new shares of stock from two years ago on top of the just announced funding, so the overall number of outstanding shares should increase EVEN MORE.
It does not need to be a pump or scam for its share price to reflect a CONTINUED failure to launch for SEVEN PLUS YEARS.
The switching of the indication was the latest puzzling move when you look at it ALONG WITH the deadline they have given. It is a SMART move switching to a new indication for the LONG TERM. However, again, factoring in the deadline makes it a bit unrealistic to me. I have to see it be done before believing with Vivis’ track record. This will take time in my opinion. Real product. Yes. I will be very surprised if preclinical trials for a BRAND SPANKIN’ NEW INDICATION during a PANDEMIC is done by May.
You speak with so much confidence about buyouts but then ask the most basic questions. If that isn’t pumping...
Cautiously optimistic.
POSSIBLE approval August 2021 - January 2022.
Seven years and counting rooting for them.
I’m just cautiously optimistic is all.
I am too but I’m kind of not. It seems like Vivos has been pumping for the first time since James C. Katzaroff and putting out distractions trying to bide time. Someone said that it is running on “hype.” I totally agree. New investors are asking questions and or are shocked about things covered several years ago.
Also, aren’t restrictions expiring or are expired from the funding from two years ago that was supposed to put Vivos in a significantly better position at the negotiation table for a significantly bigger funding? I believe someone mentioned it already on this board as well but was just buried by a ton of comments that was nowhere close to being as eye catching for me.
Anyway, the “deadlines” for milestones have not been met. Originally pre-submission was supposed to happen NOV 2020 and then IDE five months later APR 2021. I do not believe that they had a pre-submission unless we are counting the whole BDD thing. Was there an explicit PR talking about a presubmission meeting? If the BDD attempt checks the box for FDA presubmission meeting, the denial was given on 28 JAN 2021 which would essentially put IDE submission in JUL 2021 with a POSSIBLE approval being in AUG 2021.
August
Your estimation is based off of a direct quote from Vivos. However, you are cherry picking info and speaking with 100% certainty.
19 JAN 2021:
Although we did not receive 'fast tracking' approval in regards to our 'Breakthrough Device" #RadioGel™, we're performing additional testing to hit our Early Summer '21 target of submission for our IDE with the @US_FDA.https://t.co/UC9qg8MHy6 $RDGL #CancerResearch #Cancer pic.twitter.com/s35Z2Zmk18
— RadioGel™ (@RadioGel) January 19, 2021