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Obviously you didn't see yesterday's Tweet where MK says FDA needs more IsoPet data to determine if Radiogel is safe and effective as his justification for IsoPet continuing to be his top priority:
You may have noticed we are promoting our IsoPet® division more than ever these days and this is why... #IsoPet #RadioGel #VivosIncUSA #NewGeneration #CancerTreatment #SavingLives #PetCancer $RDGL pic.twitter.com/ljK0705H6W
— Vivos Inc. (@VivosIncUSA) March 13, 2024
Wrong. Here's the quote from MK's Dec. 20, 2023 PR: “We are pleased with the FDA’s decision to grant Breakthrough Device Designation following our recent data submissions. The FDA did a very thorough review. The analysis in our Risk Management Report concluded that RadioGel™ is intrinsically safe and our animal therapy data verified its effectiveness."
Now, only three months later, he says FDA needs more IsoPet data before making such a determination if Radiogel is safe and effective.
Face it, MK is a confirmed serial liar. This is but the latest example. The guy has no credibility.
? Either MK was lying in Dec. 2023 that FDA determined Radiogel to be safe and effective or he's lying now that FDA needs more IsoPet results before making that determination. Take you pick.
The guy is a confirmed serial liar. That was but the latest example. It is what it is.
You can't refute the facts regarding MK's serial lying, incompetence and apparent insanity, so you fabricate bogus ad hominem attacks against me. Sorry, have never met MK, let alone ever worked for him or in an organization he ever worked for. I cite facts from RDGL's own updates and financials; whereas you pumpers fabricate lies against me rather than even attempt to rebut the facts I cite. That's because you can't.
Here's but the latest example: In Dec. last year MK said the FDA had concluded Radiogel is safe and effective. Yesterday he said, no FDA hasn't made any such determination and awaits more IsoPet data before doing so.
The guy is a confirmed serial liar and has no credibility. Facts are facts.
Please, IsoPet was launched 5 years ago. Yes there have been quarters where it was sold above cost. In most the the recent quarters it was sold below cost. In any case, neither the margins when profitable or the volumes indicate any feasible path for RDGL to become profitable via IsoPet before cash well runs dry. RDGL has millions in overhead to cover. It's hopeless after 5 years. Nobody is buying offerings cuz of IsoPet business potential.
The only thing that can save RDGL now is getting Radiogel to human trials to allow company to sell an offering a far better terms that was possible to date, yet that is MK's lowest priority and IsoPet remains his highest priority. That's both gross incompetence and insanity.
Please just read the financials. IsoPet is generally sold below cost. Even in rare cases where it's sold above cost, there no hope of getting volumes required to become profitable before the cash well runs dry. RDGL has millions in overhead to cover. IsoPet would need very both high margins and high volumes to be profitable. There is no reasonable hope for IsoPet saving RDGL.
It insane that this remains MK's highest priority when the only thing that can save RDGL is getting Radiogel to human trials. Yet here we are in March 2024, and MK has failed to submit a single item that FDA needs to consider Radiogel for human trials.
Point is after 5 years IsoPet business never took off and is now hopeless as a vehicle to save RDGL. To continue as MK's top priority just accelerates the cash burn and delays progress on only thing that can save RDGL now. MK appears both incompetent and insane to continue this folly.
Agree that lying requires an intent to deceive. A poor forecaster isn't a liar. But here there is a years long pattern of apparent intentional deceit. There is no evidence that FDA has added any suggestions beyond those first suggested in 2021 (after MK wasted 5 years before even approaching FDA about Radiogel human trials). MK has never used that excuse. But there are plenty of examples of MK wasting time resisting and foot dragging against those 2021 suggestions.
Take the genotoxicity omission flagged in early 2023 when FDA reviewed MK's years long delayed response to comments from first meeting with FDA in Fall of 2021. That implies genotoxicity was brought up in 2021 and FDA was dissatisfied with MK's response in 2023. Maybe MK used data in his response from prior version of Radiogel, not the 2021-22 version RDGL seeks to take to human trials? He's made that mistake before with FDA.
Likewise with MK's repeatedly lying in 2023 about completing the rabbit testing and writing up results, only to later reveal, no testing remained ongoing into 2024 and write up is now in progress before submission for third party review before submission to FDA. He never used FDA adding anything as an excuse for those misstatements. If fact he said the continued testing had been long scheduled. Sure looks like a bold faced liar to me.
Likewise with his Dec. 2023 statement that FDA determined Radiogel to be safe and effective. Then yesterday he reveals FDA has yet to make any such determination and needs IsoPet data from U. of Missouri to do so. So appears he lied in Dec. 2023 in a failed attempt to pump the last offering.
In short, I go with Occam and conclude the guy is a serial liar. In any case, he has no credibility.
Need volume. Without volume pps is meaningless. Yesterday was only a fraction of already very low average volume.
I'm not buying today's Tweet referring to U. of Missouri data from years ago before the 2021-22 process "improvement" and that maybe MK just lost sight of the context of today's Tweet justifying IsoPet remaining his top priority and erroneously threw in that U. of Missouri data as a non sequitur example of very poor writing.
Any such data from before the process 2021-22 “improvement” is of no value now. FDA is only going to consider product RDGL seeks to take to human trials, not the version used before their polymer cook died in 2021.
So I take his Tweet at face value as written that the FDA “will” consider some future U. of Missouri data to determine if Radiogel is safe and effective. So it appears per the Tweet that FDA has yet to do so, confirming MK lied that FDA did so back in Dec. 2023.
What libel? I'm just citing RDGL updates and financials. Per those documents, MK is a confirmed serial liar:
In 2021 he lied about submitting the IDE application within 90-120 days of May 24. 2021, a forecast he never withdrew. Here we are in March 2024, and he still hasn't submitted an IDE application.
In 2022 he lied about having sufficient cash on hand through IDE submission. There have been a number of offerings since, each at worse terms than the offering before.
In 2023 he lied about completing the rabbit testing and writing up the results.
In Dec 2023 he lied about FDA determining Radiogel is safe and effective. Today, March 13, 2024 he says FDA is waiting on data from U. of Missouri before making that determination.
So again, where's the libel? I'm just citing facts per MK's own hand. Facts are facts. It's all there for anyone who cares to read RDGL updates and financials.
MK revealed in his Tweet today that FDA has yet to determine if Radiogel is safe and effective. That is in complete contradiction to his Dec. 20 PR. Either he was lying then, or he's lying now. Take your pick.
In addition, saying Tweet is referring to prior completed data set from U. of Missouri, makes no sense in context of Tweet justifying MK's continued distraction with IsoPet. He's not referring to his past wasted effort in that regard, but rather justifying an ongoing effort to peddle IsoPet and how that helps progress Radiogel to human trials.
Tweet also confirms, contrary to MK's claim for months now, that FDA has yet to determine if Radiogel is safe and effective and is waiting on data from U. of Missouri to make that determination, something MK has concealed until now.
The guy has no credibility.
Moreover, that prior study was with prior version and therefore useless for getting approval for human trials with "improved" process version now used. Also none of those prior studies were monitored over the critical 10 days or so before virtually all Y90 has decayed to harmless Zr90. Yes, Tweet is clearly referring to data from U. of Missouri that has yet to be submitted to FDA.
Not according to today's Tweet. Tweet says the U. of Missouri data will support pre-clinical investigations FDA requires as evidence of safety and effectiveness. Doesn't say has supported but rather says "will" support. Per Tweet, it's clear that said data has yet to be submitted. There's no ambiguity about that.
This is a new revelation of data FDA is still waiting on that wasn't previously revealed. Moreover today's Tweet confirmed that MK has been lying since Dec. 20 that FDA already determined Radiogel to be safe and effective.
The guy has no credibility.
Dr. Toskich isn't the PI on that Mayo human trial glioblastoma treatment with a competitive Y90 brachytherapy. Yet he reposted the Tweet from the Mayo PI. He is clearly promoting that product, not just "using what's available"
Sad that if RDGL had competent management, Radiogel would have already been on market many years ago before the original patents expired. Yet here we are after 8 years of MK's "leadership", and he has yet to submit a single item FDA needs to consider Radiogel for human trails. That's gross incompetence.
Today MK revealed there are even more items FDA is waiting upon that we didn't know about, and that he lied about FDA already determining Radiogel is safe and effective. The guy has no credibility.
And in the meantime while MK has yet to submit a single item that FDA needs to consider Radiogel for human trials, alleged RDGL advisor Dr. Toskich continues to promote a competative Y90 brachytherapy, not Radiogel:
https://twitter.com/BeauToskichMD
Mayo Clinic is participating in @bostonsci's #FRONTIER trial, assessing the safety & technical feasibility of TheraSphere, Y-90 glass microsphere radiation therapy, in recurrent #glioblastoma patients. https://t.co/OEG5H86xrK@DoctorQMd @RabihTawkMD @wchrisfox @BeauToskichMD pic.twitter.com/Z41jlMl8W4
— Mayo Clinic Neuro (@MayoClinicNeuro) March 5, 2024
Sorry, it's just a fact. Hopelessly impractical and unprofitable IsoPet is clearly MK's top priority. Now 5 years post launch, that's both gross incompetence and insanity. It is what it is.
And same Tweet revealed FDA awaits U. of Missouri data to determine if Radiogel is safe and effective. Beyond being a new revelation of what RDGL has yet to submit to FDA, it confirms MK lied about FDA already making that determination of safety and effectiveness.
What else is going on that MK hasn't revealed? With today's Tweet I reasonable question his sanity and if he even has any clue what's going on with FDA.
Yep, gross incompetence on display. Per today's Tweet MK says IsoPet is his top priority to "increase likelihood of IsoPet becoming a practical solution in the treatment of animal cancer". So he acknowledges now 5 years after launch that IsoPet remains impractical, but can't bring himself to acknowledge there is no remaining path for IsoPet to save RDGL. Fact is that window closed log ago. It's too expensive for the broad pet market and sold below cost. In short, it's hopeless. Yet it remains his top priority. That's both incompetence and insanity!
Then he writes in same Tweet about FDA needing Univ. of Missouri animal data to demonstrate safety and effectiveness. That's both a new one and confirms he lied about BDD status confirming FDA already accepted Radiogel as safe and effective. Per today's Tweet, FDA has made no such determination and awaits more data in that regard.
We already knew about the rabbit data from JHU that MK has so far failed to submit to FDA. Now he reveals FDA is also waiting on U. of Missouri data. wtf is going on at RDGL? Does this nut job even know?
Sorry, it's all there in RDGL updates and financials for anyone who cares to read. IsoPet is hopelessly unprofitable. Yet it remains MK's highest priority. That's gross incompetence on display.
Per recent updates, RDGL is still unable to manufacture Radiogel to FDA standards. MK is messing with basic issues that competent management would have put to bed years ago.
Facts are facts.
And what does pps mean at continuing anemic volume? Didn't even hit already very low average volume yesterday. Gotta keep it real.
There is no correlation to see. FDA needs controlled and monitored animal data to consider Radiogel for human trials. To date, MK has failed to deliver any animal data to FDA. Uncontrolled and unmonitored IsoPet treatments of one off dogs, cats and horses are anecdotes, not data.
Now 5 years post launch, there is no chance of IsoPet becoming profitable within cash runway left. It's a hopeless distraction from only thing that can save RDGL now. RDGL still can't manufacture Radiogel to FDA standards. Clearly Radiogel progress has suffered because of MK's hopeless distraction with hopelessly unprofitable IsoPet.
What defamation? It's just a fact per RDGL updates and financials that MK is a serial liar going back years now.
And note there isn't any evidence this "improved" process has any performance advantages over version tested and sold years prior to those "improvements".
That weak process patent can't stop generics from entering market should Radiogel ever be approved. And no worries about generics entering animal market; MK has demonstrated it's hopelessly unprofitable.
Irrelevant question. Trademarks for possible future products with gamma and alpha emitting isotopes aren't going to save RDGL, so like IsoPet, it's a distraction from immediate urgent task at hand. The only thing that will save RDGL is getting Radiogel to human trials before the cash well runs dry. That makes everything else a distraction.
Pure fabrication. RDGL doesn't make Y90. RDGL buys Y90 as needed and processes it immediately to finished product because it has no shelf life. It must be purchased, processed into finished product and rush shipped same day.
Moreover, RDGL was publishing papers and selling Isopet well more than a year before filing patent on "improved" process. That would make the "improved" process patent invalid if RDGL was always using the "improved" process from getgo.
Already answered
Less than $5K traded so far today. What does pps matter at anemic volume?
Nonsense
Until 2022, RDGL made and sold the Battelle version as IsoPet. That's the version that most of the animal treatment anecdotes came from. To say they couldn't figure out how the make it is ludicrous. We also know the reason for the "improved" process that required RDGL to start over with FDA was RDGL lost their polymer cook in 2021 and incompetent MK didn't have a written manufacturing ticket how to make the gel. He had to work with 3rd parties from scratch to make the gel and disperse the Y90. It wasn't a planned process revision. Again, MK's gross incompetence on display.
Moreover, there is no evidence the "improved" process offers any performance advantages vs. the pre-2022 version.
Oh, and doesn't RDGL only have one patent? Patents applied for and not yet granted aren't patents.
Need volume
I'm sorry you're in denial that the last of the original patents expired in 2022 and Radiogel is public domain now. It's just a fact.
RDGL's "improved" process patent and the application patents applied for (assuming some or all claims are granted) can't stop generic competition.
That's the price of gross mismanagement. It is what it is.
Another deceptive Tweet today implying IP barriers to entry that RDGL doesn't have after the original patents expired in 2022. Neither the single "improved" process patent in hand and the application patents applied for can stop generic entry. Only way to to stop generics is price Radiogel low enough that it's not worth effort to compete against it. That's the price for failing to get Radiogel to market before the original patents expired.
If submitting IDE any time soon, best can be hoped for is a conditional approval, which is bad news. Per RDGL updates, there's just too many unresolved issues for human trials to commence any time soon. That's the price of MK's never ending distraction with hopeless IsoPet and the wasted years resisting FDA suggestions. It is what it is.
Au contraire, I'm just citing the facts per RDGL updates and financials. Not my fault MK keeps crapping on his own stock with his deliberate deceptions and gross incompetence. It is what it is.
Again, Radiogel was invented well over 20 years ago. MK took over 8 years ago and has since wasted most of that time peddling hopeless IsoPet at expense of getting Radiogel to human trials. He waited until Sept. 2021 to talk to FDA about human trials. The last of the original patents expired in 2022, so Radiogel is public domain now. That means most of the potential value has evaporated because the potential pricing power is gone. That's gross incompetence.
Per MK's own updates, we're nowhere close to human trials yet. RDGL can't even manufacture Radiogel to FDA standards. In short, MK is still messing with basic issues that competent management would have wrapped up years ago. That's gross incompetence.
And the guy is a confirmed serial liar to boot. In 2021 he lied about submitting IDE application before Sept 21, 2021. In 2022 he repeatedly lied about RDGL finances. In 2023 he repeatedly lied about completing the controlled rabbit tests and writing up results, only to later reveal testing hadn't concluded. Now in 2024 he again claims testing has concluded and results are being written up to be submitted for 3rd party review before submission to FDA.
Nobody really knows what's going on because MK isn't a credible source for anything.
That's part of the ineptitude, trying to get to Radiogel to market without sufficient funds to do so. Time is $ too. Then to make matters worse, he's wasted most of that money on hopelessly unprofitable IsoPet at expense getting Radiogel to market. Moreover, he lost most of the potential Radiogel value when he failed to get Radiogel to market before the original patents expired in 2022.
By any objective measure, MK is a gross incompetent.
And has been a cluster and a half since. Radiogel was invented decades ago, and due to MK's 8 years of ineptitude dealing with FDA, not a single human has been helped by Radiogel to date.
Um, he hasn't saved company from bankruptcy yet. Not even close. He hasn't even gotten Radiogel to human trials yet, let alone getting it FDA approved, which is only thing that can save RDGL.
Never have met or worked for MK, but can say he's a deceitful gross incompetent per his own updates.
Company has been around much longer than the last 8 years MK has led and most of the dilution was with first failed CEO. MK did save company 8 years ago, but since then has been a disaster getting Radiogel to human trials and clinging to hopeless IsoPet. Anyway, that was all long before I was long RDGL. Just glad I no longer have skin in game given the piss poor management without any supervision from BOD.
And where exactly are we today? RDGL can't even manufacature Radiogel to FDA standards yet. Competent management would have had this all wrapped up years ago.