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Would be nice to get an update on the FDA meeting....
Too much money on the line to sit silent. Hopefully Monday we get some good news
Because this update is nothing to fret about I suppose? Go back to sleep.
Hoping to hear some solid information on the meeting today but I do realize Monday is most likely when we hear an update on the FDA meeting.
It is 5:20 pm on the East coast. Could be that the meeting is just wrapping up or if the meeting is further west, maybe it is still ongoing. I hope to see at least a Tweet on the meeting today sometime.
If it is material, they have to notify shareholders within (?) 4 days....right?
Whether good news or bad...the silence has me concerned.
Makes me think this could all be a scam...after all, look at MJNA - total scam and they own lots of shares (unless I missed something).
Appreciate every word you said. I canceled my order and will wait to see if there is a good reason to jump in.
If the company doesn't issue any impressive updates in the next month or 2, I expect share price to settle back down to low 2 cent. Figure that extra 50k shares will be nice to have if we get to a dime next year
I have my order in for 150k shares at 2 cents. Will see if it fills over time or not.
I am watching and waiting - hoping they become profitable and the share price goes up!
I am thinking I could get into this at 1 cent (or possibly below) if the AS/OS increases...thoughts?
I'm in. No comments from me until we get an update on the meeting with FDA.
Data from IsoPet helped (past tense) RadioGel...100% true. But is IsoPet providing any useful information for RadioGel at this point or even in last ~ 2 years? No. Per last update RDGL will submit information from last 5 years: "Listing and then addressing all the FDA comments over the last five years, and then providing the answers - sometimes for the second time" - I have no doubt some IsoPet data is included in those answers, but ever since they changed their formulation and manufacturing process the FDA has required RDGL to submit information that was already submitted but with the old formulation/process, hence the "sometimes for the second time".
You can almost feel CEO's frustration with having to tell the FDA the same information twice, but in reality, the FDA is saying, essentially...yes you provided studies on RadioGel to provide us answers to X, Y, Z but after you changed your formula/process those answers do not count any longer. We need that same information for the new and improved RadioGel.
Frustrating for CEO and shareholders, but it is what it is. And for this shareholder, IsoPet is now a major distraction and has been for about 2 years (whenever they changed their formula/process).
Agree. 100% of the focus of the company should be on IDE. Every penny and minute, every Tweet, should be IDE.
Agree. With today's update there is a light at the end of the tunnel.
IDE 2024
Admin - please sticky the post I am replying to!!!
Thank you for the post! Great to see a detailed IDE update.
My guess is FDA will want genotoxicity study data in the IDE.
Regardless, it appears the genotoxicity information is the last hurdle to IDE.
My prediction is IDE submittal by July 2024 - based on my GUESS of how long the genotoxicty study will take.
I am looking forward to an update after the meeting with FDA!!!
Or you are a long and your current cost average is well above current levels and you cannot sell without taking a huge hit.
Your list isn't comprehensive and since it is targeted towards me and a couple of others...you get this.
Disagree. The Mayo Clinic doesn't work with new science or technology that doesn't work - that is a factual statement. RadioGel works...but that doesn't mean the CEO is competent from a BUSINESS perspective. CEO is a good scientist, no doubt. The Mayo Clinic is interested in getting IDE approval from FDA for IDE and they are ASSISTING on that front and ONLY that front. The business side of RDGL (CEO competence, business cash flows and timelines, etc.) isn't touched by nor cared about by Mayo Clinic.
To be fair, to date, the CEO SEEMS unable to move IDE forward at a fast pace, forward progress is VERY slow. The competency of our CEO will be proven when we submit IDE in a timely manner where more shares are not sold thus further diluting shareholders. The CEO may or may not be able to accomplish IDE submission based on what shareholders know from last Q report as there is less than 1 years worth of funding for company before they run out of money.
If our CEO would Tweet out status of IDE progress (genotoxicity study status for instance) it would sure help to reduce anxiety of long shareholders who care about timelines and the funding status of the company - as they are directly tied to the company's ability to accomplish the goal of IDE approval by FDA.
Call everything above whatever you want...but those are basic facts that cannot be logically refuted. Anything can be emotionally refuted, and that seems to be par for the course for those here that post never-ending cheerleading and/or constant bashing of fact based critiques of the company.
Until we have some good news on IDE...share price will not go up. This was and is my prediction and seems to have been true for last year +. Might have been a couple of quick spikes in share price, but nothing sustained. So I guess I am a hater for not loving share price in the 5 and 6 cent range...I can handle that.
My idea here is to sell my 270k shares at a much higher price than my cost average... which is now at 9 cents. Could I continue to buy more shares and average down further? Yes. Will I? No. Company has not given me any reason to buy more shares. Other people may buy more shares after last 10Q and last several Tweets which are either about IsoPet or broad cancer treatment posts...I am not one of them.
If I sold now, I would lose a bunch of money. I'm in too far to cut and run, especially when there is still a CHANCE that IDE is submitted by RDGL and accepted by FDA.
The singular reason why I am critical of this company is because of the darkness surrounding IDE. ZERO updates on progress on the SINGLE thing that will see our share price skyrocket and give hope to cancer patients. Frustrating to say the very least.
I would love for anyone on this board to tell me why, as a shareholder, I should be happy about IsoPet updates and complete silence on IDE from RDGL. I'll wait...
I don't think he said any of those things out of willful malice. I think our CEO is a smart scientist but not a good businessman.
If he was a good businessman, he would know how long it will take to do x, y, z to get IDE. At least a rough timeline...but he has told shareholders nothing for months about IDE timeline. No milestones, nothing.
I think he is inept to a degree.
Also, read the most recent 10Q and see if you can find anywhere a timeline to get IDE approval from FDA, which is required in order to perform human trials.
The science works and is amazing. The business side of RDGL...not so much from what I've seen. I've been here just over a couple of years
Amazing how so many can skip all of the basic facts.
But he will make sure IsoPet is posted on Twitter...guess we are 2 of the few contrarians on this board who believe RDGL should focus on IDE submission.
I just noticed that volume is about 2x the 10 average volume...this is great to see!!!
You talking about the next Q report? Must be, because this one wasn't magical in any way, wasn't good at all imo.
Agree 100% - read the last Quarterly report for the facts...
Really paying off? Not according to the 10Q...according to most recent quarterly report IsoPet is barely made 5 figures last 6 months, LOSING money, lots of it. Unless IsoPet can start generating revenues of $100k+ per quarter (asap, then per month, then per week) on a short timeline, it is of very little value to shareholders who want to see this company save human lives. IMO the CEO should pull back on expending time and money on IsoPet (not completely abandon, for obvious reasons) and focus on getting IDE requirements finished and set up final meeting with FDA. It could be that the CEO expects tons of revenue from IsoPet soon but no indications of that in any Tweet or the Q report.
Investing, I have observed, is almost always lady luck is involved down in the pink sheets/OTC. The science is there, it works great and Mayo Clinic is on board to assist our board with getting IDE completed so that sways the balance in investors favor a bit. Johns Hopkin's is also on board, thus boosting the chance investors will make money. So far...all longs are still betting and hoping.
Notice where Mayo Clinic's focus is...IDE. Where is my focus? IDE. Where is CEO focus? Seems to be IsoPet as of late. Where are the cheerleaders focused? Both.
The market is pricing this stock under 6 cents....why? Lack of substantial progress on IDE submission - plain and simple. Now, I realize this could all change with one press release but to date the genotoxicity study still needs to happen and then get submitted. These things take time - nothing is going to happen "soon". Honestly if we submit the IDE this year I will feel VERY lucky. Most likely sometime next year for IDE submission...and that is IF they can stretch out their cash on hand to that point or they will need to sell more shares to keep the lights on.
A well thought out post with both possibilities laid out, the good and the bad. I am still waiting. I have moved money and will jump in but need to know these guys are on the path to bring in lots of revenue and become profitable...tick tock
All quiet on the AXIM front...
No bashers here, only: fanboys with rose colored glasses on, longs who are riding free shares, and longs who are underwater (like me) who desperately want this company to succeed but are losing patience with the lack of progress to IDE submittal to FDA. Might be some others on here but all in all, for most of the posts on this board, I believe the vast majority fall into those 3 categories.
Just because i don't see any evidence to support such a quick IDE submittal doesn't mean I wouldn't be ELATED if it happened.
What makes you say this?
I sure hope you are right!!!
I would suggest the Mayo Clinic doesn't trust the company...it trusts the science behind RadioGel - no more, no less.
No official timeline from the company. Many people here say it is coming soon, but I can't see it that way. I expect 6-12 months min before we submit IDE.
If it happens sooner...great!!
True... but Mayo will still be here if this company fails at IDE submission/approval. Mayo is helping RDGL do the testing and science.
Funding operations at RDGL isn't part of what Mayo is doing for us. And funding to complete all required tests and submit IDE is the concern.
Mayo isn't involved in the business side of RDGL.
I know exactly what I own. I own shares in a company with an exciting, safe, effective, novel cancer treatment that Mayo Clinic believes in. Unfortunately, in order for this company to save lots of human and pet lives, it needs IDE approval from FDA to move forward with human clinical trials. If that doesn't happen, I have a lot of fear that this company will become bankrupt. The longer it takes to complete all testing requirements per the FDA, the higher the chance this company goes bankrupt and nobody benefits from this new science. Facts...
Not going to exit and take such a big loss...just not going to do it, at least not at this point.