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Whole market says IsoPet is a loser. It is what it is.
Not when the product is sold below cost. No matter the volume, IsoPet is a loser. Facts are facts.
Again, they posted the Jan. down date on Twitter in early Feb.
Nothing fake from me. Just citing the facts per RDGL updates. Hard to see Radiogel getting to human trials this year as MK is still messing with issues that competent management would have put to bed years ago. Guy has been a complete cluster and a half for 8 years and counting.
You mean turd drop after turd drop, IsoPet Tweets, Mayo training pushed off again, can't even manufacture Radiogel yet, etc.
Why? We've seen past strings of MK's IsoPet Tweets drive pps down for years now. Why expect different outcome now? IsoPet is a hopeless distraction.
This is an FDA play, nothing more. Only thing that matters is getting Radiogel to market.
5 years after launch, no profits and selling IsoPet at a loss says otherwise. IsoPet is a hopeless distraction.
RDGL is the topic, not me. Your lies about me don't change the facts that MK is a confirmed serial liar and a cluster and a half manager of RDGL.
Stock chart says otherwise. Gotta keep it real.
Best to at least take risk off table in fomo liquidity event. In event of conditional approval or rejection, sp will crash. That's the risk. If IDE approved without conditions, there will be a bigger fomo event, because some newbies will confuse that with FDA approval. But then the offering to fund human trials will bring it all back to earth.
Big question is can MK deliver any of this? It's been 8 years and he's never focus on getting Radiogel to market. Many steps to go before human trials, yet MK continues to waste time and $ on hopeless IsoPet.
Please, this is an FDA play, nothing more. Only thing that matters is getting Radiogel to human trials or RDGL dies. Now 5 years after launch, IsoPet is a hopeless distraction.
So says MK. Market doesn't believe him anymore. He's lied too many times about too many things. The guy has no credibility. Then per his most recent down dates, we know even if MK isn't lying about BDD status for Radiogel, it has no impact on getting Radiogel to human trials. MK is still messing with stuff that should have been resolved years ago. RDGL can't even manufacture Radiogel to FDA standards yet.
All facts
What does it matter when IsoPet is sold at a loss? Then read the financials. IsoPet was launched 5 years ago, and never made a profit. It's a hopeless distraction.
Market says otherwise after years of MK's gross mismanagement and serial lying. How many more times is MK going to repost the stupid squiggly line or iceberg Tweet excuses for lack of progress? How many more stupid Tweets are we going to get about hopelessly unprofitable IsoPet?
You're denials of MK's proven serial lying and incompetence doesn't change the fact he's a serial liar and incompetent.
He lied multiple times in 2021 about submitting an IDE application, in 2022 about RDGL finances and in 2023 about completing the rabbit testing.
He wasted 5 years before discussing Radiogel human trials with FDA in 2021, and to date he has not submitted a single item FDA suggested they'd need to consider Radiogel for human trials. He continues to flush $ down toilet peddling hopelessly unprofitable IsoPet at expense of getting Radiogel to human trials.
All facts per RDGL updates and financials. It is what it is.
Yes, MK save company from bankruptcy 8 years ago. Then wasted 5 years until 2021 before even talking to FDA about human trials. Then he resisted FDA suggestions, wasting another 3 years. So here we are, two months into 2024, and to date MK has failed to deliver anything FDA needs to consider Radiogel for human trials, not a single item. All facts per RDGL updates.
That's gross incompetence.
But it is a requirement for human trials. There is no way FDA will approve human trials conducted by unqualified physicians. There is no comparable product to Radiogel. At moment there are no physicians fully trained to use Radiogel.
If RDGL submits IDE application before successfully manufacturing Radiogel to FDA standards and training the Mayo physicians, best they can get is a conditional IDE approval if not an outright rejection of application. Pretty sad after 8 years, MK is still messing with basic stuff like this and not ready for human trials.
The guy is a gross incompetent.
aka a conditional IDE approval. If that's what they're seeking, and here we are at end Feb., it's very hard to see Radiogel human trials starting this year. Is what it is.
It's right there: "qualified by training and experience". There is no comparable product to Radiogel. No way FDA is going to allow unqualified physicians to conduct human trials, and at moment, no physicians are qualified to use Radiogel on humans. That's what the certification process is to address. Again, this ain't the animal market.
Then why is RDGL doing it? Just MK flushing more $ down toilet? No, since physician training is in IDE human trial plan, it will have to be done before human trials, or FDA will shut whole thing down. Likewise human trials can't begin until RDGL can manufacture Radiogel to FDA standards. This ain't the animal market.
Then best that can be hoped for is a conditional approval. Hard to see human trials starting this year.
Never said otherwise. But in that case (Mayo docs not certified at time of IDE submission) best RDGL can receive is a conditional approval with a check list of items that must be completed to FDA satisfaction before human trials. Likewise for the manufacturing problems with Radiogel. All these issues have to be resolved before FDA will permit human trails. Again, MK is still messing with basic issues that competent management would have put to bed years ago.
RDGL is paying Mayo for the training time. There is no cost to Mayo or the Mayo docs. Mayo does nothing for free.
If MK submits IDE before Mayo docs are certified, FDA at best will issue a conditional approval with a punch list of items that must be completed before human trials. Among those will be docs fully certified and Radiogel manufactured to FDA standards. There is no way FDA will approve human trials until all these issues are resolved. Again, MK is still dealing with very basic issues that competent management would have put to bed years ago.
Hard to see human trials starting this year. It is what it is.
Now that's complete nonsense. Per today's Tweet, Mayo docs remain uncertified. There is no way FDA will permit human trials until that's resolved.
When? And what nonsense? There remains no end in sight to getting Radiogel to human trials.
Per Jan. down date, RDGL still can't manufacture Radiogel to FDA standards, and per today's Tweet, Mayo certification is now pushed out to sometime "This year".
All facts.
Wrong! Stick to facts! Per today's down date on Twitter, Mayo Drs remain uncertified to use Radiogel, and completion of that certification training is now pushed out to "This year".
Looks like they already Tweeted the Feb. down date today. Mayo certification training, previously forecast for 4th quarter 2023, then pushed out to this month, is now pushed out to "This year".
In short, there remains no end in sight to RDGL getting Radiogel to human trials. It is what it is.
Two back-to-back down dates from RDGL on Twitter. Yesterday's video regarding hopelessly unprofitable IsoPet, and today's confirmation that Mayo certification training isn't complete with forecast completion now pushed out to "This year".
Hard to see Radiogel getting to human trials this year. Only February, and looks like incompetent MK has already flushed 2024 down toilet.
I'm citing MK's Jan. update, not speculating about what his uncorroborated BDD claim means. Are you saying MK lied in Jan. update?
That's what I'm doing, citing RDGL updates, in this case the most recent Jan. update, which confirmed RDGL can't yet manufacture Radiogel to FDA standards. It is what it is.
The January update confirmed MK can't yet manufacture Radiogel to FDA's GMP standards. You didn't feed me anything in that regard. Per Jan. down date, MK still doesn't know shelf life of polymer intermediate and is doing root cause analysis of impact the filtration step had on finished product. All basic manufacturing issues like those would have been put to bed years ago by competent management. But MK is a confirmed gross incompetent.
There is no way FDA will approved human trials until these matters are resolved. It is what it is.
There is no evidence of FDA moving the goal posts. What we do know is MK has resisted FDA suggestions at every step and takes years to respond to FDA comments. Since FDA flagged the genotoxicity omission in the years late 2nd draft IDE application, in all likelihood FDA brought up genotoxicity from get go and was dissatisfied with MK's very late response. Also not FDA's fault that MK waited 5 years before been approaching them about Radiogel human trials in 2021, after lying about submitting the IDE application no later than Sept. 21, 2021.
And IsoPet is hopelessly unprofitable and sold below cost 5 years after launch. MK is just flushing $ down toilet by continuing to promote it.
The guy is a confirmed serial liar and gross incompetent. All facts.
He's just citing the facts. MK has been at helm 8 years now and has grossly mismanaged RDGL. IsoPet is a hopeless distraction. The only thing that can save RDGL is positive human trial data with Radiogel. Yet, getting Radiogel to human trials is clearly MK's lowest priority per his updates (which makes them down dates). He cant even manufacture Radiogel to FDA standards yet, but still wastes time and $ he doesn't have peddling IsoPet sold below cost. That's gross mismanagement.
Then there's MK's serial lying about IDE submission in 2021, RDGL finances in 2022 and his claiming rabbit testing complete multiple times in 2023. Market doesn't believe him anymore without independent corroboration.
Fact is MK keeps crapping on his own stock, not the rational commenters who call out the emperor has no clothes.
For background, RDGL is fairly priced in the 5 cent range given the risk. Dec. offering for more than 4% of company was in the 6 cent range. Retail person buying flea farts atm should reasonably expect to pay less, hence the 5 cent range. Moreover, to close last offering, MK had to renegotiate expiring warrants from previous offerings out to 2027; that says it all. Then there's fact MK failed to get Radiogel to market before the last of original patents expired in 2022, so any mega buyout offer potential is now off the table. That said, RDGL remains a lesser FDA play and people can trade it accordingly if they so wish.
Back to the moment, RDGL is having trouble holding a nickle now because of MK's piss poor management and proven serial lying. Only thing that matters now is getting Radiogel to human trials, and MK has made clear in last few updates, that is his lowest priority. Sadly, IsoPet remains his highest priority and the market doesn't care about IsoPet, as it was launched 5 years ago and never took off.
Those are the facts.
Stop reading after the big pps lie. People been pumping this loser for years now. Even GS could only pump it for a couple hours on that bogus Dec. 20 BDD news pump and dump. MK has been caught lying too many times about too many things. Then today MK drops another IsoPet turd on Twitter. only to almost immediately take it down. wtf is going on at RDGL?
Stop the lies. RDGL is currently skimming a nickle/share, not 6 cents. Why claim pps is 20% higher than it is?
We've had guidance from FDA since 2021 after MK wasted his first 5 years before even talking to FDA about human trials, and in those last 3 years, MK has resisted FDA suggestions at every turn, hence why to date he has yet to submitted a single item FDA needs to consider Radiogel for human trials. All facts.
Sad when a pumper has to lie about pps. We're skimming a nickle now.
What "submission process"? It's been 8 years. MK wasted 5 years before even approaching FDA about human trials, and in the 3 years since, MK hasn't submitted anything FDA suggested, not a single item. All facts.