WALLnut
18 hours ago
You’re deliberately twisting the facts again. First, let’s be clear—Vivos has been working with the FDA for years, refining their submission based on direct feedback. Sprint discussions and withdrawn applications absolutely do count because they shape the final IDE submission. That’s how regulatory approvals work.
If the FDA needed more safety data before accepting an IDE, then gathering and providing that data is the correct process. The fact that Vivos is still engaged with the FDA means they are working toward an IDE that will be approved, not just submitted for the sake of saying it was.
The real question is, why are you so obsessed with pushing this ‘never submitted’ narrative when the process clearly involves ongoing FDA interactions? Either you don’t understand how regulatory approvals work, or you do—and you’re just trying to mislead people.
RDGL
WALLnut
18 hours ago
You keep repeating the same tired narrative without understanding how the FDA process works. MK’s 45-day statement was based on the FDA’s feedback at that time. But here’s what you ignore—when the FDA requests additional data or meetings, that takes priority over submission. That’s not lying or incompetence; that’s following the regulatory process.
And let’s be real: if MK were ‘incompetent,’ the FDA wouldn’t still be engaged with Vivos. They don’t waste time on companies they don’t take seriously. The fact that sprint discussions are happening shows the FDA wants this done right, not rushed.
So, instead of pushing a false narrative, try keeping up with reality. The FDA—not MK—controls the timeline, and every step Vivos takes is based on FDA requirements, not your personal impatience.
RDGL
WALLnut
20 hours ago
Your argument falls apart when you actually understand how the FDA works. Sprint meetings aren’t scheduled by MK or Vivos—they’re scheduled by the FDA. The timing of each meeting is entirely up to them, not some imaginary delay tactic.
And let’s talk about your ‘final sprint meetings’ claim. If you actually followed regulatory processes, you’d know that multiple sprint discussions are common for new technologies like RadioGel. Each one addresses specific issues until everything is aligned for approval. The fact that the FDA is still engaging means the process is moving forward—not stalled.
As for your '45-day' argument, that referred to a specific step in the process, not an immediate guarantee of submission. Regulatory pathways take time, especially for a novel therapy.
So instead of trying to twist reality, maybe try understanding it first. The FDA controls the schedule, not MK, and every sprint meeting is a step closer to approval.
RDGL
mikepgator
1 day ago
The primary focus of this trial is safety, and getting the data required by the FDA to resubmit the IDE application. All this talk from SC8 is nonsense.
Public Title of Study:
Testing the Safety of a gel-based radiotherapy treatment for cancer that has spread into the lymph nodes.
Scientific Title of Study:
A Study of the Safety of RadioGel (Yttrium-90 Phosphate suspended within a Hydrogel Delivery Vehicle) as Brachytherapy Device for the treatment of any solid recurrent or metastatic tumors involving the lymph nodes associated with cancer, accessible by percutaneous direct needle injection. A Phase 1 Study
Primary Outcome:
The occurrence of adverse events will be used to determine the safety of RadioGel. The determination of adverse events will be based on in-person evaluation by the treating physician and verbal reports from the patient whenever an in-person, virtual or telephone contact is established. Symptoms related to nerve function (such as new development of hoarseness), dysphagia, odynophagia, of vascular injury will be evaluated to determine if related to the brachytherapy and clinical adverse events to be recorded include local pain, local infection, persistent skin erythema or ulceration, injury to larynx or esophagus, nerve dysfunction as manifested by voice dysfunction after 24 hours (to account for local anesthetic effect), vascular injury, hemorrhage, development of abnormal fluid collections, venous thrombosis, neuropathic symptoms, aspiration, laryngeal dysfunction, and dysphagia.
BBANBOB
1 day ago
WALnut
I appreciate your stance and concern over misinformation but having been in the markets for some 50 yrs, I have found that message board chatter really doesn't direct or control the value of a stock.
THE STOCK and its performance in it's specific industry does.
IN short the success of a company and it's product control the PPS.
If IF IFIN it is effective and works, those involved in the project DR's, Nurses, Clinical help start telling friends, then the milk man, barber, UPS driver ect ect ect
I have already directed several here, I directed one here that, IF IF IFIN he came to play here he has the ability to drive this way north based just on his financial ability to buy a literal ton of shares,like the daily vol on a whim
And like you Thank for the civility in your response and I hope your long wait pays of well for you
GLTY and to all here
Gobsmacked01
1 day ago
Isopet provides us the advantage of anecdotal comparison to our clinical trial patient. Our possible Class II brachytherapy for humans has an animal treatment history treating tumors on creatures as small as a ferret and as large as a horse WITH PICTURES, lol.
30 days out, of course the radiation is gone and has been for weeks, but the gel is seen still dissolving, releasing destroyed tumor cells for resorption, and reducing the tumor footprint size. Overtime only a minimal site indication remains if any.
Does a Class III more dangerous device deliver the same 80% tumor reduction in 30 days? Not if the glue holds, otherwise it has released a LOT of glass or resin beads into the patient potentially causing organ harm.
Isopet rules! RDGL is showing results! The rest is just waiting, imho.
-Go $RDGL