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Nope, class 2 has always been on the table and Isopet has provided examples of prototype for FDA.
I think the microsphere migration problem is reasonably well understood. Isn't this clinical study on our company info, Admin?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4861585/
I am bullish, not fearful. I was referring to the bottom of their home page where they state:
There are thousands of Brachytherapy devices approved and in use. The difference between their products and RDGL is simply that they use microscopic glass, resin, or steel darts/beads while our product is at the molecular Y90 phosphate level. The microscopic beads have a history of contamination / side effects in patients, no?
Interesting that someone is using "Glue" instead of our gel, but then their website is pretty clear they are not approved for human use anywhere yet. I would imagine they might be quite concerned about how much better our product is over theirs...
-Go !RDGL
Makes sense to me.
FDA: technicals look good, so who is your Document Control person?
RDGL: We need infrastructure for Human Trials to proceed now?
FDA: Who do we communicate with, same person, from now thru your trials?
RDGL: We'll need a week or two to hire someone...
And here we are...
-Go $RDGL
I am encouraged that FDA sounds like their emphasis is on Cost/Benefit ratio... That sounds to me like they are seriously considering a more safe Class II designation for our Human Trials!
The share price may suffer short term due to the delay moving forward, but a Class II determination for Human Trials combined with our Breakthru Device Designation (BDD) last December would be well worth an additional summer buy opportunity, imho!
Would that make us the only Class II brachtherapy device in a $30 Billion Dollar Market possibly by this time next year?
-Go !RDGL
Everyone here signed up for E-Mail updates from the company?
My guess is an email update mebbe this weekend followed by an official PR of where we are at early to mid next week.
I am not surprised the share price now matches the offering price.
-Go $RDGL
GTSM on both the bid and the ask and it represents both Retail and Investment pools moving money in the trillions(aggregate)?
Soooo, who might be sucking up the 1 milly+ per day trading volume pre-FDA news?
How does it make sense for the same DMM algo to transact 6 figures in our stock on the daily with itself?
LOL
-Go $RDGL!
My thoughts are to wonder how the RDGL device is being treated by the FDA?
In other words Brachytherapy is not some new device... it has a decades long history.
Y90 is not a new radioisotope for cancer treatment... it has a long history as well.
The gel is an original formulation and the Y90 is far more pure than currently approved bead brachytherapy solutions.
Is FDA approving this as a new device? A new formulation for an already approved device? A human safety improvement from category 3 to 2 (more safe) for an existing device use justified by the Breakthrough Device Designation?
The answers could significantly affect/shorten the typical timeline here, no?
Discuss /explain if anyone here is up on all that stuff please?
- Go $RDGL
I think its a difference between investor communication and investor relations.
Example: No further communication tween now and Friday after markets close drops share price even if 5p on Friday they tweet that they submitted to FDA at the close n they are just on Pacific time so it was early afternoon for them.
Compared to a relational approach: Tweeting today to stay tuned for an important tweet on the FDA submission at the open on Friday.
With an investor Relation approach, they innoculate a little for possible bad news that the 3rd party, FDA recommended numbers review company ran late resulting in a mid-July submit target... or they set up for a Friday Feeding Frenzy announcing pre-Market that the package is completed, submitted, and the beginning of FDA review may be delayed by the Holiday, etc...
Its always good to warn the team when heading into the guard rails...
-Go $RDGL$
As I have said before, different folks will process their numbers their own way. A source for some numbers:
https://www.grandviewresearch.com/industry-analysis/brachytherapy-devices-market
If 2023 was a $970 milly target market for Brachytherapy, back of a napkin number could be $1 Billy for the brachytherapy market using 2022 numbers for 2024 and a CAGR of over 7%.
Ruffly 411 Milly shares outstanding for Vivos:
https://www.otcmarkets.com/stock/RDGL/security
Market $ divided by outstanding shares yields $2.43 pps
IMHO, our post successful human trials numbers could look VERY different for several reasons:
Brachytherapy that can address/improve the existing side effect profile AND is proven to interact well with Chemo, etc standard treatments in Human trials as a Break-Thru Device could leap frog Brachytherapy as an industry forward to significantly more common usage.
ie: chemo or radiation for systemic treatments in CONJUNCTION with our brachytherapy for local tumor kill with better patient outcomes. (across 18 tumor types?)
https://www.americanbrachytherapy.org/about-abs/about-abs/
-Go $RDGL$
n if it matters to you, nope... I ain't a math guru eether, lol, just tossing out numbers n reading material for the weekend. Do yer own DD, I'll be trolling the county for roadside metal
Lol, i'm not sure yer message was directed to me. IMHO, of course, means i am only expressing an opinion.
Now that i gotta return two beer cans for each share i buy, i'm starting to look hard at ma yard n i'mma consider a 'metal run' mebbe, just to buy more shares... that make me a guru? I'm not some kinda animal from Australia's outback if that's the way i came across to you.
Lol, i am no guru, and i don't recommend anybody take my investment comments as advice... few of you could drink that many beers
-Go $RDGL$
IKR? Just thought i'd throw that out there for thinkers to digest during the trading break tomorrow.
Anyone curious as to whether or not the tech works/is effective? Check out Isopet! Safely used on mammals as small as cats (with their 'everything happens fast' metabolism), small dogs, and mammals as large as horses. Tumors destroyed were ranging in size from small to big enuff for a horse!
-go $RDGL$
The thing is, a $500 milly MC by Christmas will seem pretty reasonable once/if human trials are approved.
That would be around $1 pps.
That would be a 5X gain from .20 pps.
That would be a 3X+ gain from .30 pps.
IMHO, folks who think RDGL following the FDA's path for approval that has the highest percentage approval will rightfully be the most richly rewarded buying under .30 pps.... cuz those buying around .50 pps in the coming weeks/months will only be doubling their money in the short term.
-Go $RDGL$
Next week, its time to get NAUGHTY!
Lol
-Go $RDGL$
Chart Question: i am sure others on this board are way better at charts than i am...
What happens when the 10 day moving average volume is below or at 1 milly shares, VWAP is .25-.30 per share traded, RSI is in oversold territory on the 10 day and we then enjoy 3 days in a row of 10+ milly share volume trading?
Does that trigger something attention getting from investing type trackers/folks?
-Go $RDGL$
MM's are the only folks that can trade that many decimal places out, i think. Lol i think our company here is fiscally deciding not to blow cash on attracting stock action like some other OTC plays i've seen. Why dilute to raise money, spend it getting the word out to raise the share price and then continue that spiral if it does nothing dollar for dollar to get FDA approval?
IMHO, this sets us up for a "bursting onto the scene" style event/run. By the time the chasers n swing traders and momentum folks plug in, we could be within the 30 day approval window. THAT could be a wild ride!
-Go $RDGL$
Umm, are you still thinking we are OTC, right? Other folks on here know better than i, but if an empty shell has value for a reverse merger, then our Isopet licensing and use of our IP across as many as a dozen domestic vet clinics could have value to a multinational conglomerate looking to add Isopet to their product pipeline, no? Profit, revenue, cash flow would be the concern of the buyer...
- Go $RDGL$
Hey there, Wallnut, the May update described their business restructuring effort. The u0date is a good read!
I didn't intend to state they were doing a spinoff n sale, i asked what possible reason(s) they could have for doing it? Several come to mind... the business heads here would prolly have even better ideas, lol. What wouls an Isopet sale look like? I think Dr Mike is keeping all options open n on the table. Is a spinoff possible? What would that look like?
-Go $RDGL$
Lol, i had to stop my monthly pedicure n carefully set that Dremel tool down cuz it occurred to me: Did we just get informed Isopet is being setup as a stand-alone division such that it could be spun off n sold to an international Vet Medicine company?
You business folks on here help us out... A dozen licensed clinics doing the world's ONLY Precision Radionucleotide Brachytherapy (FDA approved for non human) cancer treatment covered by pet insurance... would that sell for $50 milly? $500 milly? Enuff to fund the remaining hunan trials costs n possibly buy back sone Reg A offering shares?
IF I see it in the .14 pps range again, i may have to turn in more bortles n cans for the deposit to buy more shares!
-Go $RDGL$
Any more .14 pps shares for me to pick up today?
Please???
My favorite clips from this week's update: MAY 2024
By their request, Vivos Inc. is working with Akina, our polymer contractor, to design a general laboratory
chiller for laboratory use since the capability for controlled cooling which we patented for our chiller
would have general applicability.
and
Michael K. Korenko, Vivos, Inc. was accepted at the International Radiation Protection Association (IRPA)and
IRPA 16th International Congress and 69th Health Physics Society Annual Meeting - July 7-12, 2024 –
Orlando FL.
IMHO, IP adds value along with growth and expansion into human treatments INTERNATIONALLY across the board... not just the IDE that will be under FDA consideration for human trials if not approved by the time Dr. Mike presents to the International Congress and Physics Society in mid July.
Stay tuned!!!
-Go $RDGL$$$
Completed, passed, and available on youtube!
I am not implying anything and past performance is NO indication of future price per share... but having said that have you checked out their chart for the Q1/Q2 time frame in 2012? There was a previous FDA submission that was waaaay unsupported compared to data available this time around. Where did the pps go back then?
-Go $RDGL
I've often seen a big dip to trip stop losses and acquire shares juuust before a big pop.
I think it'll be awesome to close today at or below open, get typical update info at 6p (nothingburger in the grand scheme), and then gap up Monday... except we've already traded up to .27 pps this week so it won't be a gap needing to fill.
- Go $RDGL!!
For the big picture, read thru their filings, PR's, and/or X tweets/updates...
As a start, visit their webpage:
By June 2024
-Go $RDGL!!!
Using their $7.4 Billy number from 2023, if they only get 10% of that Market Capitalization, then we are looking at roughly $1.90 pps with the current share structure... interesting.
They identify other targeted uses as well:
Nice! AND if you turned in your beer cans today you could buy a share in the company for every 2 cans returned!
I might finally need to clean out the bins n bags in my garage... my 2002 SUV could use a headlight upgrade to these new fangled LED headlights!
Hay, anyone think we might see .30 pps in a month or two? Pappy needs to reattach some running boards :-p
-Go $RDGL!!!
And yet yesterday's trading pattern looked to me like maybe 100 share/200 share low ball trades trying to trigger "stop loss" share sells for someone to pick up cheap volume.
Some of us have seen what THAT looks like before, short term... lol
Ahh, crap! Now that I said that out loud Imma gonna hafta recycle more cans tomorrow n pick up a couple more shares...
Next time someone chats with Dr. Mike, maybe they could bring up patient immune response testing and share a reply here?
Pre-mRNA vaccine, virus cells with inactivated DNA were grown and used as the vaccine for flu, measles, etc... Given that the patient absorbs the tumor post treatment with Isopet/Radiogel, is there a way to test immune response in the patient to the absorbed tumor cells? Can a successful Radiogel/Isopet treatment be demonstrated to create a patient specific immune response similar to vaccination for future occurrences of similar cancer cells/ tumors?
Just spit-balling potential pieces of the iceburg here...
-Go $RDGL
Hm, the CEO is an MIT guy who got his device designated as a "Break through Device" by the FDA in a biomed market where such devices already have a 20 year history of being FDA approved... AND his device is already FDA approved and used in the Veterinarian community by doctors?
With a share price of 10 cents, maybe I'll finish this beer n then go return some weekend bottles n cans so I can buy more shares over the lunch time sell off!
1 empty recycled can per share? Volume could show up any day now...ROFL
-Go $RDGL
Whoops, I like to link to info I refer to whenever I can. We have had multiple rabbit studies done, written up and submitted to National Institute of Health, etc... despite what some fudsters may have claimed. I link an old May 2021 write up as a reference for anyone new here:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996238/
-Go $RDGL
Pre-submission share prices will likely be market driven. Timing matters.
Dr. Mike has always been clear in his communication regarding FDA and why. He says stuff will be ready to support our IDE this quarter, then that is for real...
Is it possible FDA won't receive it for review till July? I guess we'll find out, lol. Mebbe it gets submitted by Mother's Day?
Given our recent BDD status award and level of ongoing communication combined with our genotoxicity and rabbit tumor results, mebbe FDA won't need 30 days to give a go ahead for our human safety trial?
I think timing drives events that drive share price as we see results.
Bottom line: Does the deep state US or this Administration want good news on cancer therapy pre November? Post November?
I think it promises to be a fun show to watch!
-Go $RDGL
Macro Overview: Cancer costs by 2030 estimated to be in the $580 Billion market cap range.
Source:
https://www.globenewswire.com/news-release/2022/01/21/2370991/0/en/Oncology-Market-Size-to-Hit-US-581-25-Billion-by-2030.html
Brachytherapy is forecasted by some to reach $1.62 Billion in revenue by 2030. at a 10X multiple (I think Biomed has higher profit margins but 10% is conservative) that looks like $16.2 Billion usd (less than 3% of cancer market) in cancer Market share
Source:
https://www.grandviewresearch.com/industry-analysis/brachytherapy-devices-market
Cancer cases globally are expected to grow 77% by 2050.
Source:
https://www.iarc.who.int/wp-content/uploads/2024/02/pr345_E.pdf
I figger RDGL might get 10% of the brachytherapy market cap with their 18 revenue verticals identified by their distinguished MAB (Medical Advisory Board).
My guess is that they dilute their shares (111 million additional OS) in an offering once their pps is comfortably over $1 usd to raise mebbe $100 million usd to fund their growth.
At 500 milly OS, with $100milly in hand looking at a possible $1.62 Billy Market share and a 77% 20 year growth rate a price per share around $3.24 seems reasonable to me. That COMPLETELY ignores the veterinarian side as well as an expansion possibly into joint pain treatment, etc,,,
If a company wants to buy us out to preserve their own market share and possibly grow it, I imagine a $5-$10 per share buyout range might be reasonable.
Our brachytherapy has higher quality gel, NO resin/glass/metal beads, and uses a beta emitter with about a quarter inch emission range that is completely depleted in under 3 days anyway... mebbe targeting 10% of the 3% cancer market assigned for brachytherapy is too low ball?
-Go $RDGL
LOL, 2 milly share volume 10k on the ask and 5k on the bid?
I have seen this movie before... and they hate it when someone keeps buying on their ask!
-Go $RDGL
I'm buying more at these levels in place of my usual crypto weekend play...
I was waiting for whomever bought those 500k share blocks from retail in the low .05s 4 months ago to sell off n get their core out.
reset the RSI some n next week or end of month could get interesting!
-Go $RDGL
Nothing says "unicorn" like being able to claim your breakthrough device idea/product is used in creatures you can safely pet both pre and post treatment!
#35 on the breakout board looks like an event might be happening this quarter?
It looks to me like the future MOMO traders are in early entry stages?
Post submit to FDA for human safety trials, I expect volatility as the momo folks either build share count, trade to get paid, or both. Who can blame them for buying up the under .15 pps crowd when we were pushing .30 on the last submit to FDA?
Personally, I set all my shares to sell above $65pps as a GTC (good until cancelled) play. Has anyone else ever enjoyed a "locked float" price run?
This time, I think we have a MUCH higher likelihood for success/approval given our recent BDD achievement so mebbe .30pps is pretty low-balled? Time will tell...
-Go $RDGL