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wtf? They did another IsoPet turd drop on Twitter today and then almost immediately took it down.
Doesn't matter now if MK is telling truth or not about BDD. What matters is the market doesn't believe him cuz he's lied so many times about so many things. It was a Dec. 20, 2023 pump for a couple hours and then it dumped. That's all. We now know the BDD claim is irrelevant to RDGL volume and pps. It is what it is.
And the relevance to RDGL? It's a claim MK made over two months ago that market either doesn't believe or believes is inconsequential. It was good for a couple hour pump before the dump. There's only one thing that matters now, getting Radiogel to human trials, and per MK, that's his lowest priority right now.
Per volume and pps, market doesn't believe MK about BDD status and/or doesn't care. It's just a fact. Moreover, per MK's most recent down dates, many unresolved bottlenecks remain, and MK remains distracted with the hopeless IsoPet business. All facts.
Situation is what it is. While fairly priced in the nickle range, it's hard to see this not dropping further given the nonstop Twitter turd drops. To close last offering, MK had to renegotiate expiring warrants from prior offerings out to 2027; that says it all.
Where's the confirmation from FDA of BDD status for Radiogel? All we have so far is the claim from a proven serial liar. The market no longer believes MK. And if true, we already know BDD has no impact on getting Radiogel to human trials. MK has yet to bother even submitting an application for human trials and can't even yet manufacture Radiogel to FDA standards. All we're getting from MK now are more turd drops on Twitter about iceberg excuses and hopelessly unprofitable IsoPet. Looks like 2024 is another year down the toilet.
Never called for bankruptcy and you already knew that. Company is so poorly run, with MK continually distracted by hopeless IsoPet at expense of getting Radiogel to market, that bankruptcy remains a concern, but I've never called for bankruptcy.
Yep stand by that comment. 1st, MK's bogus claims aside, there is no controlled comparative data whatsoever demonstrating any safety advantages of Radiogel vs. other treatments. It's just a bogus unsubstantiated claim. And the fact is standard of care in most cases, should Radiogel ever be approved, will still involve chemo, making any safety comparisons irrelevant. Hence why it is highly doubtful there will ever be any controlled comparison studies of standalone Radiogel treatment vs. other treatments. In absence of such studies, any comparative safety claims will remain bogus.
Nothing fake about my comment. Just citing the facts per MK's own hand.
Just stating the fact RDGL didn't invent Radiogel. All the original Battelle patents have expired. Radiogel is public domain now. Facts are facts.
Please, RDGL hasn't invented anything. Radiogel was invented at Battelle decades ago.
He only had to "improve" the polymer cuz his polymer cook died in 2021, and moronic MK didn't have a ticket procedure written down such that any competent lab tech could print the ticket to make the polymer. Those 2021 "improvements" meant starting over with FDA. That's how incompetent a manager MK is!
As for filtering, in his usual poor writing, MK reveals they're doing root cause determination on post filtering impact on composition, meaning something went wrong and is being investigated. It's right there for anyone to read. Again, he's still messing with stuff competent management would have put to bed years ago.
He's too busy peddling hopeless IsoPet at expense of only thing that matters now. And RDGL doesn't do any research. Radiogel was invented over two decades ago at Battelle. MK is still messing with basic manufacturing issues that competent management would have put to bed many years ago.
Please. He doesn't even know the shelf life of the intermediate polymer and he's having problems filtering the finished product. These basic issues should have been resolved years ago. RDGL is no where close to human trials.
You mean the certification training that was supposed to be done last year but keeps getting pushed off? Is the any evidence Mayo is still working with RDGL after MK lied about the rabbit testing?
The only one claiming BDD status is MK, a proven serial liar. In any case, we now know it is irrelevant to IDE process.
Please, there is no way FDA will approve human trials of a product that isn't manufactured to GMP standards. Radiogel isn't IsoPet. The human market is a whole other level. Even if MK isn't lying about BDD status, we now know it's irrelevant to getting Radiogel to human trials, as MK still has to deliver the required data to FDA. To date he's hasn't delivered anything, not a single item.
If you understood FDA GMP standards, you'd know that's exactly what Jan. down date says. Sad MK is still messing with basic manufacturing issues that should have been resolved years ago, but it is what it is. The guy is inept.
It's per MK's own Jan. down date released Feb 1 on Tweeter. RDGL can't yet manufacture Radiogel to FDA's standards. There is no way FDA will approve human trials until that's resolved. Nor has MK yet delivered a single item FDA needs to consider Radiogel for human trials. So we're no where near getting Radiogel to human trials.
All facts per MK. Facts are facts
How so when RDGL can't even manufacture Radiogel yet? But rather than focus and fix that major problem, MK is off peddling hopeless IsoPet. It is what it is.
MK's nonstop down dates are out there for anyone to read. The guy is just an inept cluster and a half. Moron posted another IsoPet Tweet today. They sell IsoPet below cost. It is what it is.
Already said I think RDGL is fairly priced in the 5s given last offering, but not surprised if we go lower. MK just keeps crapping on his own stock. It is what it is.
Just citing the reality per MK's own down dates. The Jan. down date released Feb. 1 revealed RDGL can't even manufacture Radiogel to FDA standards. The down date before that confirmed MK accomplished nothing in 4th quarter 2023 he had previously forecast. MK has been a cluster and half disaster going on 8 years now. Facts are facts.
All the original patents have expired. Only way RDGL will ever see $5 beyond a very short fomo pop is via a massive rs. Best to take risk off when one can, but getting Radiogel to human trials in 2024 seems very unlikely now. It is what it is.
glta
Just objectively citing the facts per MK's down dates. He's a proven serial liar and gross incompetent. It is what it is. They even reposted the sad iceberg Tweet today, meaning there's still no end in sight.
Why do you think we're skimming under a nickle today?
Yeah right, it's FDA's fault MK wasted 5 years before talking to them about Radiogel human trials in 2021, after lying about submitting the IDE application. Likewise it's FDA's fault MK resisted their suggestions at every turn since then, such that here we are 3 years later, and MK has yet to deliver anything to FDA that they need to consider Radiogel for human trials, not a single item.
Per his last down date, RDGL can't even manufacture Radiogel to FDA standards, guess that's FDA's fault too?
How is Radiogel going to get approved for human trials, when per MK's last update, RDGL still can't manufacture it?
So why is Dr. Toskich promoting another Y90 brachytherapy device now?
What miracles? MK has been at helm 8 years now, and we're skimming under a nickle. The guy has been a disaster!
Sorry, not looking likely for 2024. MK still can't even manufacture Radiogel yet and he remains completely distracted with hopeless IsoPet. They even reposted the sad iceberg no end in sight Tweet today.
So? That just increases burn rate at expense of getting Radiogel to human trials. MK can't even manufacture Radiogel yet and wastes time and $ he doesn't have on hopeless IsoPet. That's gross incompetence.
IsoPet is sold at a loss. There's no way to make it profitable on more revenue when each unit is sold at a loss. Moreover, revenues are declining. Moreover, IsoPet would have to yield millions of $ profit just to break even. These are simple facts per RDGL financials. The only thing that can save RDGL now is getting Radiogel to human trials, yet per recent updates, that is MK's lowest priority. The guy is a gross incompetent hopelessly distracted by hopeless IsoPet. It is what it is.
Has there been any corroboration from FDA regarding MK's claim of BDD status for Radiogel? Moreover, even if MK isn't lying about BDD status, we now know it has no impact on getting Radiogel to human trials, as MK still has to deliver items FDA suggested they need to consider Radiogel for human trials going back 3 years ago now. We also know per MK, they are struggling with basic manufacturing issues that should have been resolved years ago. So we're nowhere near human trails.
Likewise, where's the corroboration from Mayo they're still working with RDGL after MK lied about completing the rabbit testing?
Just objectively citing the facts regarding RDGL and MK's inept management and serial lying. Who cares at this point that JHU vet clinic sells IsoPet when RDGL sells IsoPet at a loss 5 years after launch? Per MK, RDGL can't manufacture Radiogel to FDA standards, yet MK remains distracted with hopeless IsoPet.
That's gross incompetence on display. It is what it is.
Mayo has no involvement with IsoPet. We don't even know if Mayo is still working with RDGL after MK lied about completing the rabbit testing. We do know the certification training with Mayo keeps getting pushed off and Dr. Toskich is promoting a different Y90 Brachytherapy now, not Radiogel.
Please. MK took control 8 years ago and has been a piss poor cluster and a half manager since. He waited 5 years before even talking to FDA about Radiogel human trials, and since that time (2021), he hasn't delivered a single item FDA has suggested they need to consider Radiogel for human trials.
IsoPet was a reasonable bet when launch 5 years ago, but the bet didn't pan out. Right now, RDGL can't even manufacture Radiogel to FDA standards and MK continues to waste time he doesn't have peddling hopeless IsoPet.
That's gross incompetence.
That is sold below cost. IsoPet is a hopelessly unprofitable distraction. Facts are facts.
It's just a fact that MK lied multiple times about:
Submitting IDE application in 2021
RDGL finances in 2022
Completing Rabbit testing and writing up results in 2023
Moreover he's been caught more than once stealth editing updates after release.
The guy is a proven serial liar. It's just a fact.
I just deal in facts, not wishful thinking. IsoPet is a hopelessly unprofitable distraction that was launched 5 years ago and never took off. It's just a fact.
So? Should some or all of the "improved" application patent claims be granted (a big if), it can't keep out generics. All the original patents have expired.
So says serial liar MK. Market doesn't believe him anymore.