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IsoPet is fine for pump and dump purposes, but after 5 years, there is no path to profitability. A network news story with small audience isn't going to change that. IsoPet remains a hopeless distraction. Only remaining path to RDGL surviving is Radiogel. Yet, Radiogel is MK's lowest priority per his own updates.
Facts are facts.
All appearance of a pump before an offering with MK being dumb enough to publicize RDGL is paying for the pump. Of course pumpers will dump into the pump before offering announced, then the pps crash when the liquidity dries up again to current anemic levels.
Maybe north of $5 on a fomo pop, but unlikely buyout price given there are no barriers to generic entry. Best bet is sell into volume fomo pops and buy back if desired when dust settles.
Gotta keep it real.
Seems he's shooting for conditional approval and is pumping for another offering during consideration period before the bad news hits. Did he resolve the manufacturing issues? Have the Mayo docs been certified? No way FDA will green light human trials without those critical steps being 100% completed to their satisfaction.
Gotta keep it real
Known pump and dump promoter. MK is paying them to pump RDGL stock. Sad.
Sad. MK paying known pump and dump promoter says it all.
Yes, if MK submits IDE application with major uncompleted items like he's revealed so far, best one can hope for is a conditional approval.
No way is FDA going to green light human trials with product that isn't made to their standards or administered by untrained physicians. Those items would have to be resolved to FDA satisfaction beforehand, aka a conditional approval.
Again, you're neglecting all the credibility MK has lost since then.
Most likely there will be a hedge offering during the consideration period, which will keep pps in check. Early approval unlikely, as the default unconditional approval is for FDA to do nothing.
Then there will be an offering to fund human trials should IDE be granted unconditionally. So best bet is sell into liquidity events. Can always buy back at more reasonable prices (if desired) once the dust settles.
In event of conditional approval with no end in sight, any pop will be very short lived.
Except MK self revealed as a serial liar multiple times since then. He no longer has the credibility he had then.
You've been most accurate forecaster for RDGL so far. But will add that MK made same forecast 3 years ago (2nd quarter 2021) before revising forecast on May 24, 2021, saying he needed another 90-120 days, and he missed that revised forecast too. He's lied so many times about so many things, why believe him this time?
Already proved the element of the lie, so don't need to prove intent to deceive. It's just a fact either MK was lying in Dec. or he's lying now. Moveover, I covered the motive for the Dec. lie and/or the March lie, which likewise I didn't have to do after proving the element of the lie. He just says whatever favors him at the time, truth be damned.
MK has no credibility.
Can't get IDE approval until MK bothers to submit an application. Been 8 years and counting.
Either MK was intending to deceive in Dec. when he stated FDA had assigned Radiogel BDD status and had determined Radiogel to be safe and effective (to pump the last offering), or he was intending to deceive in March (to justify is hopeless obsession with IsoPet) when he Tweeted that FDA had yet to make that determination and needs to see more IsoPet applications to do so.
Again, take your pick when MK intended to deceive. Either way, he's a confirmed liar and has no credibility.
Just take MK's latest self-revealed lie: In Dec. PR he says FDA assigned Radiogel BDD status and determined Radiogel to be safe and effective. In March Tweet he says FDA has yet to determine if Radiogel is safe and effective and needs to see more IsoPet applications before doing so.
Was he lying in Dec. or is he lying now? Take your pick. Either way, he's a confirmed liar. That is but the latest example. The guy is a confirmed serial liar.
All facts, no opinion.
Can't slander someone on written forum. Moreover, it's not slander nor libel to cite MK's lies, incompetence and deliberately misleading statements as revealed by his own updates. Facts are facts.
You haven't refuted the facts regarding MK's serial lying and gross incompetence. You're name calling doesn't change those facts. Again, I am not the topic.
Somebody's got to keep it real. My comments are objective, not negative. I'm just citing facts from RDGL updates and financials. It's not my fault MK is a proven serial liar and gross incompetent. It is what it is.
Yep, always close and soon for RDGL, as you've been saying repeatedly for how many years now?
Just keeping it real. No wishful thinking chez moi.
RDGL has a single new patent, an "improved" process patent. That is not going to stop generic entry of the pre 2021-22 version, you know the version that saved all those animals. Moreover, there is no evidence whatsoever the "improved" process yields any performance advantages over the now public domain version. Likewise with the "improved" application patents pending (if granted); none of those can stop generic entry of the public domain version. That's what happens when patents expire; the tech becomes public domain.
Facts are facts.
Again, I'm not the topic. You can't refute the facts regarding what a piss poor failure MK is, so you try to make me the topic to take attention away from MK's failure to get Radiogel to market before the original patents expired. Facts are facts.
Radiogel isn't new! It was invented over two decades ago at Battelle and licensed by RDGL how long ago? All original patents now expired, so no generic barriers to entry. If that's not failure, I don't know what is.
Both first CEO and MK haven't by supervised by board and failed as a result. MK's been in charge last 8 years He wasted his first 5 years before even talking to FDA about human trials in 2021. Then he wasted last 3 years resisting FDA at every step. Hopeless IsoPet remains his top priority at expense of only thing that matters now: getting Radiogel to human trials. Again, if that's not failure, I don't know what is.
Just objectively citing the facts per RDGL updates and financials. Still no end in sight and hopeless IsoPet remains MK's top priority. Is what it is at end 1st quarter 2024.
Blaming me for MK's failures? Sad
You say that every quarter or month. Always soon. Yet there's been nothing but down dates for over a year now.
So expecting another down date for March next week? April update expected 1st week in May.
I'm not saying anything about pps either way at low volume. Just saying at low volume, one has no confidence of putting in market order and getting price close to last trade, aka no liquidity, aka pps at low volume is meaningless, aka keeping it real.
? Need volume for pps to mean anything. Volume remains anemic.
Have never worked for or even met MK, but here are some facts after he took over 8 years ago. He wasted the first 5 years in charge before even talking to FDA about Radiogel human trails in 2021, and that was only after repeatedly lying about submitting IDE application for human trials. Since talking to FDA in 2021, he has failed to date to submit anything they've suggested. Instead, he's resisted FDA at every turn and wastes time and $ peddling hopelessly unprofitable IsoPet. So here we are at end of 1st quarter 2024 with no end in sight.
In short, MK is anything but brilliant. Au contraire, he's a proven serial liar and gross incompetent. Facts are facts.
amen
Can't refute the cited facts regarding MK and RDGL, so you resort to ad hominem attacks.
MK said in Dec. PR that FDA had already determined Radiogel is safe and effective. Now in March he says, opps, FDA still hasn't made that determination. So either he lied in Dec. or he's lying now. If he has the balls to lie in Dec. PR, what's to stop him from lying in a 10K? It's a fool's errand to parse lies from truth once someone is a confirmed liar. Now you're saying the JH report will show Radiogel is safe.
In short, nobody knows what's going on because MK has no credibility. Have the rabbit studies at JH really concluded? We know MK has lied about that many times before. Has the report been written? Has the report been submitted for 3rd party review?
Yeah, here we are at end of 1st quarter 2024, and to date, MK has failed to deliver a single item FDA suggested back in 2021, aka no end in sight.
Skipping steps as usual. The results reports then have to go through 3rd party review before submission to FDA. And if 3rd party reviewer flags any items...........? And how many times in last year has MK said testing was complete and results write up is in progress? Does anyone really know what's going on when CEO can't be believed?
Then RDGL has to make Radiogel to FDA standards and have Mayo docs certified before IDE submission, or best that can be hope for is a condition approval, aka more meetings with FDA until RDGL is ready, and Radiogel is deemed safe and effective enough, for human trials, which brings up another of MK's repeated lies. In Dec. he claimed FDA had already made that determination. Now in March he says FDA has yet to do so. Again, the guy has no credibility.
In any case, after all this time, a conditional IDE approval would be a major setback with no end in sight.
Can't refute the facts regarding MK's repeated serial lying and gross incompetence, so you resort to making bogus accusations against commenters who point out those facts.
It's just a fact the only thing that matters now is getting Radiogel to human trials. There's no other plausible scenario where RDGL survives. IsoPet was launched 5 years ago, is sold at a loss and revenues are declining. In short, there is no way for IsoPet to save RDGL. It's hopeless. Yet IsoPet remains MK's top priority and Radiogel is his lowest priority. Sorry, but that's gross incompetence on display. It is what it is.
That's the problem; he can't. It's been 5 years since M launched IsoPet. IsoPet remains hopelessly unprofitable and revenues are declining, not increasing. It's hopeless. Yet IsoPet remains MK's highest priority while he neglects getting Radiogel to human trials, and that is only thing that can save RDGL now.
MK has been at helm 8 years now. He wasted 5 years before even talking to FDA about human trials in 2021, and that was after lying about submitting IDE application no later than 90-120 days after May 24, 2021. Yes he lied. He never withdrew that forecast.
After talking with FDA in 2021, FDA made suggestions on what they need to consider Radiogel for human trials, and to date, MK has failed to deliver any of those items to FDA, not a single one. He wasted years resisting those FDA suggestions, all while wasted time and $ RDGL doesn't have promoting hopeless IsoPet.
So here we are at end 1st quarter 2024 with no end in sight thanks to MK's incompetence. Radiogel was invented over two decades ago! Competent management would have had all this wrapped up many years ago!
Again, you're saying all those animals RDGL claims to have treated before they lost polymer cook in 2021 were bogus fabrications? Same for all the papers published on that version of Radiogel/IsoPet?
If you're claiming RDGL was selling the "improved" version years before submitting patent application, that would invalidate their patent. Likewise with the "improved" application patents pending.
Again, there is no evidence the 2021-22 "improvements" after polymer cook died have any performance advantages over now public domain version. You know, the version that saved all those animals and many papers were published until RDGL couldn't make it anymore in 2021 when polymer cook died and RDGL was out of business for several months.
Sadly, those "improvements" also meant starting over with FDA, hence all the retesting since.
Please, we already know RDGL has competitors in this gel brachytherapy space and even more in Y90 brachytherapy in general. There are no barriers to entry. That's what happens when patents expire.
You're also conflating the one patent RDGL does have with patents applied for. We don't even know what claims will be granted should those other patents be approved. In any case, none of that can stop generic entry now.
As far as claim nobody figured out how to make Battelle version, are you saying MK lied about all those animal treatments before the 2021-22 "improvements" after polymer cook died? Are you saying all those papers were fabricated? Even I don't say that about MK.
Please. Didn't RDGL apply for the application patent and jury still out if they'll be awarded patent? And prior application method that saved all those animals is public domian now. Moreover there is no evidence any of RDGL's "improvements" have any performance advantages vs. the now public domain version.
As far as available raw materials, the polymer gels (yes there's more than one that's public domain now,) are cheap to make and RDGL already has competitors using Y90. Boston Sci seems to have no problems getting Y90 for their approved brachytherapy. You know, the one Mayo is promoting.