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Please. Gel portion is cheap vs. Y90 and Y90 has no shelf life. So finished product is made to order only, must be rush shipped same day delivery with expensive hazmat packaging and used immediately upon receipt. Radiogel/IsoPet will never be inexpensive.
Gotta keep it real
What good are 20 application devices beyond demonstrating manufacturing ability of a prototype? IsoPet would need to generate millions of $ revenue just to break even. IsoPet is a hopeless distracton now. It is what it is.
Except for fact MK launched IsoPet 5 years ago and it never took off. It's a hopeless distraction now from the only thing that matters.
Again, migration is a greater concern over the ten days or so Y90 remains hot because of smaller particles vs. seeds and fact that Radiogel is targeting early cancer.
Gotta keep it real
Seed migration concerns vs. dispersed particle migration concerns. Both are valid concerns, but more so in case of Radiogel targeting early cancers. Hence why FDA suggested the controlled rabbit studies 3 years ago, that to date MK has failed to deliver to FDA.
In context of this market, useful IP means patent barriers to entry to keep out generics. Trademarks don't stop generics. Nor can a weak process patent stop generics, and that's all RDGL has. Only way RDGL can keep out generics is to price Radiogel low enough it's not worth to enter market. That lack of pricing power in turn greatly reduces any buyout price. That's what happens when patents expire. It is what it is.
No barriers to entry because all the original patents have expired, which in turn greatly limits pricing power and any buyout price. That's the reality.
Per most recent downdates, they haven't figured out yet how to manufacture Radiogel and MK remains distracted with hopelessly unprofitable IsoPet. That's the sad reality at moment.
While imo RDGL is fairly priced now given last offering and the risk, it's hard to see this holding a nickle. Just too many critical Radiogel problems that MK is neglecting while he remains hopelessly distracted by hopelessly unprofitable IsoPet.
Nothing wrong with sellers. They're reading the nonstop turd drops from MK.
What good is BDD when market doesn't believe it and MK says they can't yet manufacture Radiogel to FDA standards? MK is just a continuous cluster disaster.
Very skeptical about MK's BDD claim. Market certainly doesn't believe it. Per MK, he hasn't yet delivered any controlled data to FDA. So upon what data did FDA grant BDD status?
Very fishy. He's lied so many times about so many things......................
When? Per Jan. 2024 update, RDGL can't even manufacture Radiogel to FDA standards. These are basic manufacturing issues that should have been resolved years ago. There is no way FDA will authorize human trials until these issues are resolved. Yet MK continues to peddle hopelessly unprofitable IsoPet at expense of getting Radiogel to human trails.
We now know, even if MK isn't lying about BDD status for Radiogel, that it is of no consequence in getting Radiogel to human trials. To date MK hasn't delivered anything FDA suggested, not a single item, that they need to consider Radiogel for human trials. Then in Jan. 2024 down date, MK revealed they can't even manufacture Radiogel to FDA standards! There is no way FDA will approval human trials until that is resolved. MK is still messing with basic manufacturing issues, and yet continues to waste most of his time peddling hopelessly unprofitable IsoPet. That's gross incompetence. Then there's the problem of no IP barriers to entry, as all the original patents have expired.
I just stick to the facts, not wishful thinking. Bogus safety comparisons to other treatments without a shred of data to substantial those claims is just that, bogus. Then there's the relevance of such safety claims (if substantiated), given in most cases, Radiogel will be used with adjuvant therapies.
Like MK, you're making comparative safety claims with no data on which to base the claims. I'm just pointing out the claims are both bogus and irrelevant.
Back to RDGL, the facts are MK has grossly mismanaged RDGL over the last 8 years and counting. The market doesn't believe him anymore.
It is what it is.
Serial liar MK claimed to receive BDD status for Radiogel on Dec. 20, 2023, and could only pump RDGL for a couple hours before the dump. That's the consequence to his serial lying. The market doesn't believe him.
btw, trademarks aren't IP and don't stop generics. That's why MK pulled his stupid Tweet claiming otherwise. Generics don't need trademarks to enter a market.
So where are the Radiogel human trials?
You quote proven serial liar MK and then claim those are FDA's words? Where's the corroboration from FDA? In any case, market doesn't believe MK anymore. He's just lied too many times about too many things.
It is what it is.
Sorry, facts are facts. Point is Radiogel isn't a panacea and in most cases will be use with other therapies, so relative safety comparisons without taking into account the adjuvant therapies are irrelevant. In this case that safety claims are also bogus because safety comparisons to other treatments without any data to substantiate those claims is just that, bogus. Yet MK's has made that dumb mistake over and over when talking with FDA, which puts everything he says under a magnifying glass with the reviewers.
Sorry, it's just a fact per MK's Jan. 2024 downdate that he's struggling to manufacture Radiogel to FDA standards. There is no way FDA will approve human trials until that's resolved. Per same downdate, he has yet to deliver a single item that FDA has suggested going back years now. Yet he continues to waste time peddling hopeless IsoPet, rather than focus on the critical matters at hand. That's gross incompetence by any objective measure. It is what it is.
Problem is commenters are confusing release dates with the time span the "update" covers (sadly been only down dates through 2023 and continuing so far into 2024).
The 4th quarter 2023 down date was released in turd drops on Twitter over many days in Jan. 2024 before being posted on website blog on Feb 1.
The Jan. 2024 down date was released Feb. 2 on Twitter. To date it hasn't been posted on company website.
So some commenters are referring to an expected March update, when they mean a Feb. update expected to be released in early March. A March update isn't expected until early April, etc. That assumes RDGL is indeed back to monthly updates.
Market says otherwise
An 8 year old bio doesn't change fact he's been a disaster the last 8 years.
Just citing the facts per MK's own hand. Bogus accusations against me don't change those facts. Per MK's down dates to date, RDGL is nowhere close to getting Radiogel to human trials, yet he continues to waste most of his time peddling hopeless IsoPet. That's the situation. It is what it is.
Market volume says otherwise. Market no longer believes MK's claims after he's told so many lies about so man things.
Haven't had Feb update yet (likely another down date) and you're looking for a March update?
Per MK's Jan. turd drop earlier this month, RDGL is nowhere close to IDE submission/approval. He can't even make Radiogel to FDA standards and he has yet to submit anything FDA suggested back in 2021. All facts per MK. It is what it is.
It's also a fact there are no IP barriers to entry as all the original patents have expired. It is what it is.
This is strictly an FDA play, nothing more. Problem is CEO MK is very inept playing that game and getting FDA what they need to consider Radiogel for human trials. IsoPet animal version was a reasonable bet to make $ to fund Radiogel developement, but it was launched 5 years ago and never took off. IsoPet is a hopelessly unprofitable distraction now, and MK remains consumed in that distraction at expense of only thing that matters now: getting Radiogel to human trials.
Please, we're talking about hypothetical neoadjuvant and/or adjuvant therapy before and after Radiogel treatment to maximize odds of success. Purpose of those treatments is to attack unseen and undetected microscopic cancers away from the primary tumor, as it is well known such metastases are stimulated to grow upon death of primary tumor. Radiogel treatment will have no impact on dose or duration of such neoadjuvant and/or adjuvant therapy, hence why safety comparisons to other cancer treatments are irrelevant.
Moreover, even if such safety claims were relevant, there needs to be data to substantiate such claims. To date RDGL hasn't conducted any such controlled comparisons, hence why MK comes off as an idiot when he spouts off such nonsense at FDA meetings.
Just citing the facts per MK's last down date. Until RDGL can manufacture Radiogel to FDA's GMP standards, there is no way human trials can commence. And that's putting aside the fact MK has yet to deliver a single item of data that FDA suggested years ago. Instead of tackling those critical and urgent tasks, MK remains hopelessly distracted by hopelessly unprofitable IsoPet.
All facts per MK's own hand. Situation is what it is.
Again, it is well known killing a primary tumor often stimulates undetectable microscopic metastases to grow, hence why should Radiogel be approved, for most early solid cancers, the standard of care will involve both Radiogel and chemo.
In short, contrary to nonsense often posted here, Radiogel is not a panacea.
In any case, it's all academic at moment, as we're nowhere close to human trails per MK's own down dates. And rather than focus and resolve the manufacturing problems and get FDA the needed animal data, MK is off peddling hopelessly unprofitable IsoPet. The guy is a proven gross incompetent eight years and running.
Ignoring the fact there are no IP barriers to entry should Radiogel be approved. All the original patents have expired. Only way to keep out generics is to price Radiogel low enough it won't be worth the effort to compete. So any buyout price will be reduced accordingly.
First, Radiogel has to kill healthy tissue somewhat beyond tumor margins, or the treatment is for naught. So your "no exposure to healthy cells" is nonsense. And again, in most cases should Radiogel be approved, chemo will be part of the treatment, so safety comparisons to chemo are irrelevant. Moreover, you're making same error MK often does of making containment and safety claims for Radiogel without any data to support those claims; hence why the FDA suggested the controlled and monitors rabbit testing, that MK has failed to date to complete and submit to FDA.
The reason FDA suggested genotoxicity testing for Radiogel and didn't for other brachytherapies is obvious: Radiogel is targeting early cancers when a patient has much more to lose vs. brachytherapies targeting late stage cancers to extend life somewhat when the patient has almost nothing to lose. Since FDA flagged the genotoxicity omission upon reviewing MK's years late response to comments from first meeting in Nov. 2021, in all likelihood, FDA asked about genotoxicity in comments before 1st meeting and was dissatisfied with MK's years late response.
No pumping or bashing chez moi. Just objectively citing the known facts per MK's continuing nonstop turd drops.
Please, this isn't an either/or situation. Should Radiogel be approved, for most early solid cancers, the standard of care will involve both Radiogel and chemo, as it is well known killing a primary tumor often stimulates microscopic metastases to grow. Saying Radiogel is superior to chemo or is a replacement for chemo is just a silly apples/oranges comparison of no value whatsoever.
My comments regarding Dr. Toskich now promoting Y90 radioembolization are both factual and in response to a commenter citing Dr. Toskich's Tweet to that effect that the commenter wrongly claimed was Dr. Toskich promoting Radiogel. Moronic commenters on Dr. Toskich's Tweet did the same. The fact is we have no idea if Mayo's relationship with RDGL survived MK repeatedly lying about the rabbit testing, but we do know Dr. Toskich is promoting a different Y90 product now, not Radiogel.
Facts are facts.
That was the Jan. 2024 update released in early Feb. Said they need 6 weeks to write up before submitting results for 3rd party review before submitting to FDA. So unlikely to happen any time soon. Moreover, MK said same through most of 2023 before revealing in Oct. 2023 he lied about completing rabbit testing. So who knows what's really going on?
Bigger problem revealed in same Jan. update is they still can't meet FDA's GMP standards. Hard to believe MK is still messing with basic manufacturing issues, but that's the situation. There is no way FDA will approve human trials until that is resolved.
So still no end in sight. Yet MK still wastes time and $ peddling hopeless IsoPet. That is gross incompetence.
Interesting. Since Radiogel targets early cancer and has no role in late stage cancer treatments, seems role for thyroid cancer treatment will be very limited. From the article you cited:
"thyroid cancer is difficult to diagnose in the early stages because it is mostly asymptomatic, making diagnosis and treatment difficult.".
"Tiny thyroid cancers exist undetected in up to one-third of all adults’ glands, and the vast majority of these are never detected or cause any clinical problems. As tiny nodules are difficult to biopsy accurately, any nodule smaller than 1 centimeter in size may not require further evaluation.".
How many times did MK say in 2023 that rabbit testing was complete and results were being written up before revealing he lied in Oct. 2023? So why believe him now? Then once written up, the report has to go through third party review before submission to FDA. Same for genotoxicity testing results.
Then there's the manufacturing issues reveal in Jan. No way FDA will approve human trials until that's resolved.
Then upon IDE approval, RDGL has to do an offering to fund human trials. Mayo won't do anything, including initial patient recruitment, until paid.
There is no way all that gets done by March. Still no end in sight.
That's keeping it real.
Has there been any corroboration from FDA regarding MK's claim of BDD status for Radiogel? And if so, so what?
We already know per MK, BDD status has no impact on getting Radiogel to human trials. He still has to deliver the data FDA suggested years ago, and to date, he has failed to deliver anything. Moreover, his Jan. update revealed he's struggling with basic manufacturing issues required per FDA's GMP standards. So there remains no end in sight to getting Radiogel to human trials.
That's the current situation. It is what it is.
Just citing the facts. Dec. 20 BDD "news" was a pump and dump that didn't even last a couple hours before sell off. Current volume says it all. There are consequences to MK's nonstop continuing turd drops. It is what it is.
Funny. Even GS couldn't pump this turd for more than a couple hours on MK's Dec. 20 BDD claim that still remains uncorroborated. The dump commenced that same day. That's what happens when CEO has lied so many times about so many things. In any case, we now know, even if MK is being truthful this time, that BDD is of no consequence to getting Radiogel to human trials. Ball remains with MK to get FDA the data they've been asking for since 2021. Likewise, MK has to manufacture Radiogel to FDA's GMP standards before human trials. Situation is what it is.
Market doesn't believe MK about BDD, and we already know, even if true, it is of no consequence getting Radiogel to human trials. Ball remains in MK's court to get FDA what they need to consider Radiogel for human trials. To date, he has failed to deliver a single item FDA suggested going back years now. Moreover, the Jan. update revealed RDGL is struggling to meet FDA's GMP standards. So still no end in sight to getting Radiogel to human trials, yet MK continues to squander time and $ on hopeless IsoPet.
Likewise we have no idea if RDGL's relationship with Mayo survived M's lying about the rabbit testing. We do know Dr. Toskich is promoting a different Y90 brachytherapy now.