Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Per prior updates, one last training session remained incomplete. Today MK Tweets that last session has been completed. Let's hope he's not lying about this too. He's been caught lying so many times about so many things, so who knows?
Now, has he also resolved the manufacturing problems to FDA's satisfaction?
Again, your denial of the cited facts doesn't change the facts.
Just citing the facts. Facts are facts.
Until today's Tweet, per prior updates, Mayo docs had not completed training needed for IDE approval. I'm glad progress is being reported, and note that, contrary to what other commenters posted in error, today's Tweet confirms completion of that training is an IDE requirement.
Let's hope MK is being truthful this time.
Again, no one can refute the cited facts that MK is a confirmed serial liar as revealed by his own RDGL updates and financials, that he wasted his first 5 years in charge before even talking to FDA about Radiogel human trials and failed to get Radiogel to market before the original patents expired. So they resort to off topic ad hominem attacks against commenters who cite those facts.
Name calling, threats, bogus accusations, other ad hominem attacks and off topic inquiries directed at commenters citing those facts, doesn't change the cited facts.
The facts are what they are.
BDD, even if true, has proved irrelevant for getting Radiogel to human trials. Contrary to MK's lie in Dec. PR that FDA determined Radiogel to be safe and effective, on March 13 he Tweeted that FDA has yet to make that determination. Ball remains in MK's court to get FDA what they've been asking for 3 years now, and to date he has failed to deliver a single item.
All facts.
You accused me of libel. I just rationally and objectively cited the facts regarding MK's confirmed serial lying per his own updates going back years now. So again, where's the libel? It's just a fact MK is a confirmed serial liar per his own updates. It is what it is. Facts are facts.
What libel? Per his own updates, MK repeatedly lied about submitting the IDE application in 2021, RDGL finances in 2022, completing the rabbit testing in 2023 and in Dec. 2023 he claimed in a PR that FDA determined Radiogel to be safe and effective. Other RDGL updates and financials refuted each of those lies above. Per his own updates, MK is a serial liar.
Again, don't blame me for MK's character flaws and ineptitude dealing with FDA. It is what it is.
Again, I am not the topic. Have never met or worked for MK or RDGL. I just objectively cite facts per RDGL updates. Per those updates, MK is a proven serial liar and a gross incompetent. He's been at helm of RDGL 8 years now. No one on this board, including me, predicted Radiogel still wouldn't be in human trials by now. It is what it is. Don't blame me for MK's severe character flaws, ineptitude dealing with FDA and failure to get Radiogel to market before the original patents expired.
Again, some need to look in the mirror.
I'm just keeping it real by objectively citing facts per RDGL updates. How do you think I correctly forecast the last 4 offerings? By same criteria, I'm forecasting another offering before or during IDE consideration period. Why do you think MK now seems in a rush to submit what by his own updates appears to be an incomplete IDE application? He's even hired pro pumpers this time.
Per MK, RDGL has yet to manufacture Radiogel to FDA standards. There is no way FDA will green light human trials until that's resolved. By all appearances, MK is shooting for a condition approval and will be doing another offering soon before or during the IDE consideration period.
Again, those figures are over 3 months old now and last offering included in those cash figures was a bust. By all appearances, expenses are way up. I've correctly called last 4 offers and by all appearances, MK is pumping for another offering now.
On TV on a small market NC station, big whoop.
Those figures are over 3 months old now. RDGL expenses are way up. RDGL has already burned through more than the $ raised at Dec. 2023 since then. Why did MK hire pro pumpers if he's not low on cash and not doing another offering soon? All the signs are there, and fwiw, I've correctly called the last 4 offerings and am calling for another one now. Only question is before or during 30 day IDE consideration period?
Some need to look in mirror. I'm just a voice of reason here objectively citing facts per RDGL updates.
No pumping or bashing chez moi. Just keeping it real.
Again, what good is a conditional approval? That seems to be what MK is aiming for now as by all appearances, he's low on cash and pumping for another offering. So looks like he'll be submitting an incomplete IDE application to pump that offering.
If my credibility sucks, why at we here in 2nd quarter 2024, 8 years after MK took over RDGL, and we're still waiting on MK to get Radiogel to human trials, let alone get Radiogel to market? Face it, MK is a gross incompetent.
Just keeping it real.
Just like MK, no credibility.
And what good is an IDE application submission when per MK RDGL can't yet make Radiogel to FDA standards and Mayo docs haven't completed their training. What else will remains incomplete at time of IDE submission. What good is a conditional IDE approval with a laundry list if incomplete items?
By all appearances, MK is planning on submitting an incomplete IDE application. If so, best that can be hoped for is a conditional approval and more FDA meetings until all items are resolved.
It is what it is.
He's clearly pumping for an upcoming offering, and by his own admission, has paid a professional pumper service. Hard not to see what's going down here.
Just keeping it real.
Has MK resolved the manufacturing issues yet? Are the Mayo docs certified to use Radiogel yet? No way will FDA green light human trials until all such items are completed to their satisfaction.
Facts are facts. Gotta keep it real.
Agreed. Very clear now, MK is pumping for another offering and appears he will be submitting an incomplete IDE application as part of that pump cuz he needs $ now. If so, at best RDGL will get a conditional IDE approval, meaning more meetings until all items are completed to FDA satisfaction. Hence why MK is not anticipating getting to human trials this year. There are just to many incompleted items and cleary, MK needs $ now.
Haven't read all weekend comments yet. Not sure why some were expected a small market local CBS affiliate covering Moose's saga to impact volume or pps?
Moreover, Moose received the now public domain version, for which there are no barriers to generic entry now. There is no evidence MK's "improved" process patent offers any performance advantages vs. Moose's treatment, likewise for RDGL's patents pending.
Facts are facts.
We already know report has to be written, which per MK remains in progress. Then report has to undergo a 3rd party review before FDA reviewers have any interest in even bothering with it. All this was already covered in prior RDGL updates. Discussing preliminary results in a meeting isn't a data submission.
MK has lied too many times about too many things. Hard to pump a stock once credibility is lost. Let's see if the pump and dump pros he hired can overcome that.
And so what? We already know BDD is irrelevant. Per his March 13 Tweet, even MK admits he lied in Dec. PR about FDA determining Radiogel is safe and effective. Now he says they made no such determination.
That's no reason for IsoPet to remain MK's top priority, and we already know per RDGL updates, the BDD designation is having no impact on getting Radiogel to human trials. Ball remains in MK's court to get FDA the data they've been asking for going on 3 years now. Per RDGL updates, he has failed to date to submit a single item to FDA they need to consider Radiogel for human trials.
Facts are facts.
That's great. So why haven't the results been submitted to FDA, which is all that matters here?
Sad. Still messing with items that should have been resolved years ago. Still don't know polymer shelf life, wtf! Still haven't completed rabbit testing report and submitted for 3rd party review. All because of MK's hopeless distraction with hopeless IsoPet.
But we're not in human trials yet. So at best, FDA approval is years away. Gotta keep it real.
No plausible scenario where IsoPet becomes profitable. It's been 5 years, no profits and revenues are declining, not increasing. Facts are facts.
Gotta keep it real
No patent protection to justify anything close to that valuation. That's what happens when patents expire. RDGL's "improved" process patent can't stop generics; likewise for the other "improvement" patents pending.
MK paid them to promote RDGL, an OTC penny stock with anemic average volume. Appears to me he's about to do another offering, and given his past pumping failures, he's gone to professional pumpers this time. Of course the professional pumpers will be out before the offering is announced. Then it's Katie bar the door time when the exits clog and the volume is gone.
Let's see if the pump brings volume; that's what's missing here.
Facts are facts. Your denial of those facts doesn't change the facts. Here are just some facts:
MK is a confirmed serial liar per his own updates. Just one example: in Dec., to pump and offering, MK claimed in PR that FDA determined Radiogel to be safe and effective. Then on March 13, to justify his obsessive distraction with IsoPet, he tweeted FDA has made no such determination and needs to see more IsoPet applications before doing so.
His serial lying aside, it's just a fact is IsoPet is a hopeless distraction. The only thing that can save RDGL now is getting Radiogel to human trials.
There are no barriers to generic entry should Radiogel ever get FDA approval, as all the original patents have expired. That's what happens when patents expire. An "improved" process patent isn't going to stop generics. Only thing that will is keeping Radiogel margins small enough it's not worth it to any potential competition. That in turn limits any RDGL buyout offer.
One could go on and on regarding MK's deceptions and business ineptitude. It is what it is.
No idea. By his own admission, MK has hired a pumper(s), so appears he's going to do another offering soon. His BDD pump last Dec. completely failed to pump that offering, so now he's gone to professional pumpers. Of course, the pumpers will be out before the offering is announced.
Not saying that's how this plays out, but that's sure how it looks to me, a pump and dump setup.
Let's see if the pumpers bring volume; that's what's lacking here.
And just what has MK delivered after 8 years leading RDGL? He failed to get Radiogel to market before the original patents expired; he didn't even talk to FDA until there was less than a year left on the last patent.
Facts are facts.
We know per prior updates what hasn't been done and there hasn't been any further communications that those unresolved items are now complete. By all appearances MK is likely to submit an IDE application soon to pump an offering during the consideration period and will likely at best receive a conditional approval, aka more FDA meetings before human trials.
patience Grasshopper
Just objectively citing the facts. No pumping or bashing chez moi.
"amazing company"? Stock chart and volume say otherwise.
Beyond MK's serial lying, he failed to get Radiogel to market before the original patents expired. There are no barriers to generic entry should Radiogel get approved years from now. RDGL's "improved" process patent can't stop generics. That's what happens when patents expire.
This is an FDA trade play now, nothing more.
Facts are facts.