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Has, far as my calling MK a serial liar, I'm just citing facts per his own updates. He's a proven serial liar with no credibility. Facts are facts.
The bump from $2.5 to $5 million cash burn per year is anticipation of going to human trials. If anything, those figures are far too low given current medical inflation. Likewise for the $9 million for human trials. RDGL has been cutting and pasting those figures for years now. In any case, should RDGL submit IDE application and application is approved, raising needed funds shouldn't be a problem. A conditional approval, on other hand, meaning more FDA meetings, etc before human trials can start, would be a major setback.
So if and when RDGL submits an IDE application, I'm expecting a hedge offering to keep RDGL alive in event of rejection or conditional approval. The offering to fund human trials would be after IDE approval at much better terms.
You're neglecting fact that last of original patents expired in 2022. Should Radiogel make it to market, there won't be the pricing power to justify such valuations. Profit margins will have to be kept low enough to discourage generic entry.
Please. After 5 years IsoPet is sold at a loss and revenues are declining. The focus on IsoPet is accelerating the cash burn at expense of only thing that matters: getting Radiogel to human trials. Without that, RDGL dies. There is no plausible way for IsoPet to save RDGL before cash well runs dry. That makes IsoPet a hopeless distraction.
I'm not the topic and can't blame me for continued low volume. That's 100% on MK. I just stick to facts per RDGL updates and financials. It is what it is.
Nonsense at current anemic volume.
Who said "the sky is falling"? I'm just pointing out reality of situation. Ain't nobody on this board who forecast RDGL taking this long to get to human trials, yet here we are with no end in sight. MK can't yet even make Radiogel to FDA standards.
As far as IsoPet, it was launched 5 years ago. 2023 Revenues are down substantially vs. 2022, and IsoPet is still sold at a loss. That's hopeless by any objective measure. Yet IsoPet remains MK's top priority. That's gross incompetence on display.
All facts. Situation is what it is.
Why would any company pay that much when there's no barriers to generic entry, which will keep the profit margins low?
Hard to see IDE approval in next 9 months (remainder of 2024) given RDGL still can't make Radiogel to FDA standards, Mayo docs remain uncertified, etc. If MK is planning on submitted before all such issues are sorted, best that can be hope for is a conditional approval, aka more FDA meetings before they green light human trials.
In interim, MK remains hopelessly distracted with hopelessly unprofitable IsoPet.
Generics aren't stopped by trademarks.
As far as MK's bogus claim that RDGL's "improved" process patent "gives us the basis to extend for many years the patent protection for our proprietary Yttrium-90 phosphate particles utilized in Isopet® and Radiogel™." There is no evidence whatsoever the 2021 "improvements" offer any performance advantages vs. the now public domain version. Process patents can't stop generics. Likewise with the patents pending that may or may not be granted; none of them can stop anyone from making the now public domain version. That's what happens when patents expire.
Just another example of MK being deliberately deceptive regarding RDGL's very weak IP position. Again, that's what happens when patents expire.
All the original patents have expired. Radiogel is now public domain. That's what happens when patents expire. Your denials don't change those facts. Should Radiogel ever get to market, there is nothing stopping generic entry. That in turn negatively impacts any buyout price. It is what it is.
Yes, contrary to your claims, I never called for bankruptcy. Yes, bankruptcy remains a valid concern. RDGL doesn't have forever; nobody does.
Au contraire, I did and still do question MK's BDD claims and certainly what it means. In Dec. MK claimed FDA found Radiogel to be safe and effective. Now in March, he says FDA has yet to make that determination. Moreover, it's now clear BDD has no impact on getting Radiogel to human trials, which is all that matters. So the BDD claim, whether true or false, has turned out to be irrelevant.
Did you forgot to mention Radiogel was invented over two decades ago and MK failed to get to market before all original patents expired?
Should Radiogel ever get to market now, there are no barriers to entry generic entry. Only thing MK accomplished with his 2021-22 "improved" process was rendering all prior data worthless, which meant starting over with FDA. The "improved" process patent can't stop generics. Only way to keep out generics is to keep margins low enough there's no incentive to compete. That in turn greatly reduces any buyout price should RDGL even get that far under the leadership of this gross incompetent.
Can't get IDE approved without MK bothering to submit an application. And if he submitted now, best could be hope for is a conditional approval with laundry list of list of items to be completed with more FDA meetings to follow. Hard to see Radiogel getting to human trials this year when per MK, RDGL can't even make Radiogel to FDA standards yet. He's spending far too much time on hopeless IsoPet at expense of only thing that matters now.
The guy is a gross incompetent and proven serial liar.
Introducing MK? He's been leading RDGL for 8 disastrous years now!
Not scared of calling MK a confirmed liar. He's a confirmed liar per his own statements going back years now. Is he lying about BDD status? Hell if I know or care. Point is MK has no credibility about anything.
What we do know is the claimed BDD status isn't having any effect on getting Radiogel to human trials. That makes the claim irrelevant. MK still has to deliver data to FDA, and to date hasn't delivered anything FDA suggested going back 3 years ago now. And don't get me started on the 5 years MK wasted before even talking to FDA about human trials. The guy is both a proven liar and gross incompetent.
It is what it is.
Again, it's a fool's errand to parse truth from lies from a confirmed liar. Moreover, in case of MK's BDD claim, it has proven of no consequence for getting Radiogel to human trials, and that's all that matters now.
Gotta keep it real.
Can't get IDE approval for human trials unless MK submits an IDE application, which brings up another of his lies. He said he was going to submit that application no later than 90-120 days after May 24, 2021. That was three years ago and he never withdrew that forecast. The guy has no credibility.
Moreover, if he submits now, best that can be hoped for is a conditional approval, meaning more meetings with FDA before approval. Per MK, RDGL can't even make Radiogel to FDA standards yet and the Mayo docs aren't yet certified to use Radiogel, etc. Hard to see Radiogel getting to human trials this year.
I don't know what BSD is. Regarding MK's claim of BDD status for Radiogel, we now know it is of no consequence for getting Radiogel to human trials, and that's all that matters now. Again, I don't even try to parse the truth from lies once someone is a confirmed liar, and MK is a confirmed liar. Moreover, even if BDD claim is true, MK also claimed in same Dec. 2024 PR that FDA had determined Radiogel is safe and effective. Now he says otherwise. So we now know he's lying about that too.
Are you saying there is a plausible path for RDGL to be profitable via IsoPet before the cash well runs dry? If not, then the only thing that matters now is getting Radiogel to human trials. Everything else is a distraction.
Gotta keep it real
Never said BDD was a false claim. Did say MK has lied so many times about so many things, he has no credibility. It's a fool's errand to parse lies from truth spouted from a confirmed liar. Moreover in this case, regardless of whether MK is lying about BDD status or not, we now know it is of no consequence in getting Radiogel to human trials, which is only thing that matters now. Futhermore, when MK made the BDD claim in Dec, he claimed FDA had concluded Radiogel is safe and effect. Now in here in March he Tweeted FDA had yet to make that determination and needs RDGL to do more IsoPet treatments before doing do so. That was further confirmed in reply comments from RDGL.
So was MK lying in Dec. 2023 or now in March 2024 regarding FDA determining if Radiogel is safe and effective? Take your pick. Either way, he's been caught in another of a long string of lies. The guy has no credibility.
You've been saying "soon" for years now. When is "soon"?
Yep, MK damned by his own admissions you quoted. It's been 3 years since FDA suggested these tests in 2021. Yet MK has yet to write-up those rabbit results, submit for the 3rd party review and then submit to FDA. He lied multiple times in 2023 that the rabbit testing had concluded and report writing was in progress, long before the year end 2023 report where he again makes that claim. Discussing preliminary results with FDA isn't a data submission report, and FDA needs that rabbit data to consider Radiogel for human trials.
Fact is MK is a proven serial liar with no credibility. He's lied so many times about so many things, that nobody really knows what's going on at RDGL.
Just a fact. MK hasn't delivered a single item that FDA suggested back in 2021 when he first approached them about Radiogel human trials. Instead he continues to peddle hopeless IsoPet at expense of getting Radiogel to human trials. That's the reality. It is what it is.
What "positive developments are totally ignored"? Only thing that matters here is getting Radiogel to human trials. Putting aside MK wasting his first 5 years in charge before talking to FDA about human trails, he has yet to deliver anything FDA suggested back in 2021, not a single item.
That's the objective reality at end of 1st quarter 2024. It is what it is.
Volume says otherwise.
Point is MK is a proven serial liar and one can't believe anything he says without corroboration. Moreover, even if Radiogel was awarded BDD status, we now know it has no impact on getting Radiogel to human trials. Ball remains in MK's court to get FDA the data they need to consider Radiogel for human trials. To date per his updates, he has failed to deliver a single item to FDA.
RDGL isn't profitable, IsoPet is accelerating cash burn and there is no plausible way for RDGL to become profitable via IsoPet before cash well runs dry. Only thing that can save RDGL now is getting Radiogel to human trials. But that is incompetent MK's lowest priority now. End of story.
That was more than 3 years ago, and revenues have declined since. Face it, IsoPet is hopeless and MK is insane for continuing this folly.
Less the cost. Revenue isn't profit. And for RDGL to just break even, IsoPet profits have cover the overhead. There is no way IsoPet at these tiny margins could reach the volume needed anytime soon. And time is of the essence here.
Only thing that matters now is getting Radiogel to human trials, yet that is MK's lowest priority. That's gross incompetence.
It's not profitable. Never has been. It costs too much and the best possible margins are too small for RDGL to be profitable via IsoPet. Most of the time it's sold at a loss. That makes it a hopeless distraction.
Again, is RDGL profitable? Answer: No.
Can RDGL become profitable via IsoPet sales with present cash on hand? Answer: No
That makes IsoPet both a hopeless distraction now 5 years post launch and a hopeless $ drain, all at the expense of getting Radiogel to human trials.
It's not profitable. RDGL has millions in overhead that IsoPet profits would have to cover to achieve profitability. The window for IsoPet to save RDGL closed years ago. The only thing that matters now is getting Radiogel to human trials, and that is MK's lowest priority now. The guy is incompetent.
Bigger point is pps at low volume is irrelevant.
That was in Dec. Now MK claims FDA has yet to make any such determination that Radiogel is safe and effective and is waiting on more IsoPet treatments before doing so. Can't have it both ways. Either MK lied in Dec. or he's lying now.
RDGL's response to comments on March 13 Tweet confirm my interpretation. Either MK was lying in Dec. or he's lying now. This is only the latest example of his serial lying. The guy has no credibility.
Every pet patient treated is part of our collection of data, it is not just UOM, but all clinics. IsoPet® and RadioGel™ are our brands, one for animals, one for humans when the time comes. All data collected from IsoPet® treatments help pave the way for our RadioGel brand.
— Vivos Inc. (@VivosIncUSA) March 14, 2024
Again, the March 13 Tweet was MK’s justification for his continued, now in 2024, IsoPet efforts remaining his top priority. So I'm not buying that he's that poor a writer to throw in a complete non sequitur and now irrelevant statement from 2018 that contradicts that justification. The prior version of Radiogel in 2018 (before 2021 death of polymer cook) is irrelevant now. Hence why those 2021-22 process “improvements” meant starting over with FDA. The only version of Radiogel FDA will consider is the product RDGL seeks to take to human trials, not the prior product RDGL made before their polymer cook died in 2021.
I take the Tweet at face value. MK now claims that FDA needs to see more IsoPet treatments to determine if Radiogel is safe and effective. Moreover, RDGL's response to comments on Tweet confirm this. Whether true or false, taking the claim at face value fits within the context and purpose of the Tweet to justify what otherwise looks like insanity.
So either he’s lying now to justify IsoPet remaining his top priority, or he lied in Dec. that FDA already made that determination.
Yesterday's Tweet was very clear and was MK's justification for continuing to make IsoPet his top priority. He makes very clear in Tweet that FDA has yet to determine if Radiogel is safe and effective and FDA needs more IsoPet data to make that determination. This was further confirmed in RDGL's response to some comments on that Tweet.
So did he lie in Dec. about FDA determining Radiogel to be safe and effective, or is he lying now that FDA needs more IsoPet treatment data to make that determination? Either way he's a confirmed liar, and this is hardly the first time.
The guy has no credibility. It is what it is.
Read the two statements. Neither the Dec. 20 PR or the March 13 Tweet contradicting the claims in the Dec. 20 PR make any reference to hydrogel shelf life, so I don't know what your point is. My point is either MK lied about FDA determining Radiogel to be safe and effective in Dec. 2023, or he's lying now that FDA still needs more IsoPet data to make that determination. Either way he's a confirmed serial liar. This is only the latest example.
The guy has no credibility. It is what it is.
Facts are facts. In Dec. MK said FDA determined Radiogel to be safe and effective. Now he says FDA is waiting on more IsoPet data before making that determination. It's all there for anyone who cares to read the two statements. The guy is a confirmed serial liar; this is only the latest example. He has no credibility.
It is what it is.
And the rabbit tests. Then once written up, both rabbit results and genotoxicity results have to go through third party review before submission to FDA. Sad MK is still messing with basic stuff that competent management would have put to bed years ago.