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That is a gutsy move to highlight and track such a bad looking tumor at the stage it is in. Excellent move if it all works out, I am very confident and hopeful for the dog and family.
There are several hydrogels out there and I believe was defense department discovery/invention.
Boston scientific uses a hydrogel as a buffer between organs while using their seed Brachytherapy treatment. Could be their affiliation.
Either way, this is way behind Vivos. I was surprised at how they were inferring their treatment was such a unique treatment after researching all the other treatments available, then pick this that is 5 years behind? It is either bad research or a collaboration. If it is bad research, I can image that financial supporters will be pretty upset to find out Radiogel is or about to be available.
No way he will will wait till Nov. 1 for the testing approval yay or nay, no reason for that. The meeting went well so full details will need to be presented along with the conference outcome - as implied by the tweet.
We could use the two sentence tweet in the mean time.
Definitely can see it here where this news, although it is very important, is expected at pretty much at 85%, and will not be an out of the blue event. I would definitely be way more surprised if this did not work out.
Anyone jumping in now could justify why they purchased.
Big week ahead for sure.
I did not know this and must have missed the explanation, thank you for that.
It was hopeful thinking anyway, and we will soon get underway!
Not trying to rehash old news but I like this more every time I read it. A sample test has already been done and obviously had good results.
Wonder if they can use those results if the FDA likes the plan proposed and used.
From Radiogel.com:
US FDA IDE Pre-Submission Progress Update
In our previous meeting this past May with the FDA, it was recommended that we perform additional animal testing to confirm RadioGelâ„¢ remained at the point of injection. The FDA suggested before we initiate any testing, we send them a copy of the proposed animal test plan to review in our next IDE Pre-Submission meeting.
-Middle paragraph removed-
RadioGelâ„¢ is very efficient and delivers a significant dose of radiation by injecting a small amount of activity. This efficient low activity represents a challenge in measurement sensitivity to the degree of accuracy requested by the FDA. Therefore, it was necessary to send a member of our team to Johns Hopkins University to run a surrogate radioactive injection into an equivalent rabbit tumor model to determine if their PET could measure this small injected activity, and then remeasure it after ten days of 2.7-day half-life decay.
Me too!
No, I do not think so. There was originally going to be another meeting after the testing proposal/approval but there were no new comments outside of the agreement they will add a test to using the revised system/methods - which were originally brought up in the November meeting prior, as a may be useful item.
They should be presenting the testing results in with the application, like had previously been done.
Unless FDA discovered something else they would like to see included, the application should be submitted with the results.
The last FDA meeting would have been the last pre-meeting.
This meeting should be all but a formality where the Vivos team tells the FDA what the team needs to do to get the results the FDA is looking for. I believe a test run has already been done to make sure the results can be met with the size tumor to be treated. #slamdunk #longdrumroll #vegasbound
I have never seen that and the US Government uses Defense.
India uses Defence which may explain the early morning posts. Is the social media managed overseas?
If someone has a good connection to the Vivos web site,
under Mike's description, they spelled Department of Defense, with Defence.
I sent an email a couple of days ago and no update. They need to show they are legitimate and misspellings ALWAYS look bad.
Mike Korenko has a Doctor of Science from MIT, was a NATO Postdoctoral Fellow at Oxford University, and was selected as a White House Fellow for the Department of Defence.
Hard to believe Isopet is still not well known. I am outside of Boston and had to put out golden down last year, ER was in Waltham.
And they are at the Veterinary Cancer Society conference this week which should stir up more interest...they should pay Moose to be there.
Monday/Tuesday should be very good days.
Nice to have a specific reference date!
Who is selling at .48? Picked up 100k more just now.
Thank you whoever you are.
I do not believe there will be a need for a meeting to discuss the testing results, unless the results are bad or not useful. The results should be presented as part of the IDE submission - assuming FDA does not come up with anything else they would like to see added.
If the testing procedure is approved (and I cannot see a reason why it would not be since it is to replace the testing previously done using the original formula), this could go quickly or in a matter of weeks, let's say a month. With expected results, they get packaged into the IDE application which must already be compiled outside of this Appendix.
RDGL is more being ignored than under the radar right now, too many false starts over the years have made people very leery about jumping in which has appeared to be way too early to get excited about. Can't blame them since it has been in the works for 12 years now.
BUT, as informed and diligent investors, we know we are just before the moment(s) we have been waiting for. The stock will now move only with news and developments, not the same old re-hashed hype or known info, but progressive news. Then this will react like every other new prospective or even meme cancer treatment stock, with millions of shares traded each day and a 27X bump.
I see upward movement starting on Oct 17 (to .07). Then again after the meeting summary is released (to .09), then, I am assuming the IDE submission will be the next move and this will start the bump from .09 to .34 during the 30 day review.
When the IDE is approved it will go to .51, back down to .21 till the first results start coming out at 2 months into testing, then it goes to $1.35 with a max of $10 possible if the news gets picked up nationally.
Or I could be wrong.
.34 to .51 seem very real to me.
Agreed.
They already did a trial test to determine if the results were able to be distinguished for such a small tumor size. I wonder, if that protocol used matches the meeting protocol, could they just use that as the test.
One more thing, the SHPH stock is now down to $3.95 from $126 (Sept 1 2022) after the initial results from an early testing phase came out.
That is almost a 32 x swing on some very early good news, with a treatment that relies on separate radiation treatment and has unwanted side effects.
Imagine what RDGL will do with its expected good news and safety?
Let's say the same 32 x .05 = $1.6/share. Me likey!
Funny thing is, even when the IDE is approved or even when positive results start coming in, the negs will try to find something to complain about, twist around, or fabricate problems that just do not make sense.
I really hope they just leave instead.
France, is also pro-nuclear power generation and have continually been working on safety standards and upgrades. I believe the SR90 is a byproduct of nuclear reactors.
Once the SR90 is obtained, its half life is 29 years.
Very exciting thinking about a (successful) expansion overseas.
They should not need to transport any radioactive material overseas or across borders. The material is produced by a remote generator and I would assume, are manufactured in Germany.
Will that machine require special permits? Probably for when it is in use like everywhere else.
That would definitely be nice and seems very likely if the process would move before the treatment becomes obsolete.
Two days ago I had decided to tell even fringe friends about RDGL and the opportunity I see as a unicorn stock.
During one such session when I described the treatment vs, the old or in place treatments with the seeds, I was stopped when they started telling me about the horror story regarding his father having the seeds implanted for prostate treatment and that there have been numerous issues with the migration of seeds into his bloodstream. He is on a permanent medication that is, I believe, for blood clots.
A totally unsolicited and backwards confirmation of the Radiogel product and future of brachytherapy. People need to know this issue is real and exists with today's treatments.
Your take is kinda off.
They have requested the next meeting with the FDA to discuss the testing protocol for the new mice tumor(s). After that is approved, they do the testing and were originally going to schedule another FDA review meeting to go over the whole package. So two meetings have not happened yet before the submission.
This is where we know we stand right now.
I believe, and this is just me, that since they did not have any new review comments from the last meeting, they will have the testing procedure review meeting, perform the testing procedures as agreed upon and be able to skip the last review meeting going right to submitting the IDE application. Dr. M seemed to be truly bothered at the delay from the last meeting with his wasting time comments.
This is where I think we stand right now.
I also would not be surprised that since they had such a head start - supposedly pre-May 2022 - in preparing for the testing, they may have already done a trial test following their agreed upon, within the Vivos group, procedures, and if there are no comments by the FDA on the procedure, could go immediately to the IDE submission using these results.
That is not a rumor or hearsay but what I think could happen as an absolute best case scenario possibility. This one means nothing.
I brought up a company that had recently had its IPO a couple of weeks ago, symbol SHPH. They are in early trials and have had some good success.
After the IPO and news on trials came out, the stock shot to $124 in a few days. The market is waiting for viable cancer treatment, especially something new or improved. Market cap was up to 2.5 billion or something.
They are ending trading yesterday at $8.99.
They are evaluating a drug which is much more intensive than an application of an already approved for use compound - not a drug. They have several years left if they are able to start using their method. When and if they do, it gets used in conjunction with radiation treatment - not a stand alone product like Radiogel.
I am saying that RDGL will shoot with real news and could go even higher than I had expected.
The benefit of the stock being so low, is that when it hits meme status by regular investors (not learn-ed ones like on the mboard), it could easily continue past the 1-2 billion market cap ($3-6/share) and continue because it will be seen as a bargain stock. Up to $30 could easily be a justified share price, for a cancer treatment, that works and is being used.
I am going to set some sell orders at various levels in case I miss a quick shot action.
Was thinking 100k share at $1, $3, $6, $10, $15, $20. After that it will not have mattered because I would have already had a heart attack.
Mental note ; buy defibrillator.
We should discuss our exit plans in Vegas.
I was thinking the same, PR went sideways. The previous day's volume indicated that others knew something was coming.
I am expecting that news very soon and still believe that the last meeting may not be needed after the testing process has been presented. I re-read the December 2021 summary again and it discussed that additional testing may be helpful with the dosimetry enhancement. From May 2022, the only comment which reiterated, was the additional testing and Vivos was supposedly ready to suggest its inclusion.
I cannot see another meeting being needed with basically no new comments from the last preview meeting. IMHumbleO.
Can't wait till this starts to come in and me and my wife will be there!!
This is definitely the biggest or most expensive risk investment I have ever taken. I feel it is one of those rare unicorn situations, that we will talk about for a long time, once it comes through. Plus, how can you not feel good about the product.
Gotta say I am disappointed with that smell.
Something in the air. Smells like a #newsday.
@radiogel
#radiogel $RDGL
#PrecisionMedicine #PRnT
#cancer #CancerMoonshot
#Cancers #CancerResearch
Nice to have that quick dip to fill my .05 bid.
SWEET!!!!!!!
Finally going to see some real world advertising in The Horse and the new Veterinarian magazine just announced.
The Horse is filled with horse care and treatment ads along with treatment articles, definitely an appropriate magazine.
Maybe they are planning on expanding to magazines the owners read that are not technically based - they could push for the treatments from that end, especially if they are the ones paying.
Signed up for my subscription to "The Horse" magazine today - no Isopet ad yet in September issue. Maybe October.
You are probably right. Not that it is the same thing, but the patent applications had to be submitted more than once.
I was assuming this was just the need for additional test data with the format and presentation being approved beforehand, so could not be presented incorrectly - assuming the same positive outcome as the first tests. Whatever DrM., JH & Mayo feel should be done, I agree with anyway.
Remember, they have already done this testing and report before, with the original formula so there should just be some data and image changes.
Will there even be a need for a meeting after the testing approval meeting, or can they go right into the application which includes the new testing results? I am assuming the FDA will not be giving peace-meal advice or recommendations and gives them all comments in total for what they feel needs to be addressed. I do not believe there was anything else mentioned to be addressed.
I really hope this is the game changer that it appears to be and doesn't just flounder around.
Yes I do. I recently presented an IPO for SHPH where it zoomed to a market cap of 1.68 billion ($126/share) and has now settled to about 450 million ($33/share).
Cancer treatment drug with probably say 4 years of human testing ahead of it.
Their treatment is a drug not an application method, and basically does what Radiogel does when used in conjunction with radiation treatment.
The hype will be there (again) for RDGL when the IDE becomes real.
If this is meme/hype worthy, and it is at $1, why wouldn't people pile on and go to $5 or $10, or higher? Especially if this recent one shot up like it did.
Emotion could easily carry this way further than would be reasonably expected.
.20 on IDE submission
.41 at 29 days
1.25 at 31 days
2.5 at 90 days
Looks like you skipped over the answers everyone knows or did you forget what happened during those time periods? No need for me respond to those.
This has taken a long time (2012) and hopefully you feel that they have been progressing with the IDE approval where it looks like - unless there is a curveball thrown by the FDA - they are on the road to an approved IDE for human testing.
Hopefully you are also happy about the Isopet clinics being setup and the expansion coming into Canada. I am also assuming the addition of the treatment of horses makes you happy.
I have been loving hearing about the testing planning/coordination, website updates, etc. to show they feel this is about to get started.
Too bad the prospective patients that really could have benefited from this, have had to get treated in some other manner, most likely less effectively and at a greater expense.
So everyone is aware, my wife has had dreams that RDGL is going to $10.
Right, this test is for the use of the revised and now patented, Vivos owned formula.
Makes sense it would need to be updated since the other test benefited the original formula.
As soon as they get the OK for the test, they should be able to test right away with final results taken at 10 days and then provide a summary - using the original test as a guide/template - could be ready very quickly in a week or two. This should fold right into the IDE submission package as requested. I do not think there was anything else the FDA requested to stop them from submitting the IDE once the testing report is completed.
Going to get very exciting in the coming weeks.
I guessed at 50 million shares - I could not find a number.
$2/share will still be nice stage for stage.