Absolutely Bear. That time couldn't come soon enough for me.

I'm not sure I've been any more effective than you. Just Tommy gunning it, and hoping it gets in front of the right set of eyes.

I get it, at the moment their working on a garage budget. But I agree with you - seemingly, it wouldn't take a sales army.
Just a few regional assassins.

What's the drug dealer's addage: "I don't sell drugs, it sells itself!" I kind of think we can be bigger than drugs someday!!! LOL!

Totally agree Wall, and hopefully the good doc will handle that end.

BUT, while we wait, any ground swell that comes organically or from any of our grass root efforts, can't hurt - might even help.

Even Korenko (apparently) has taken the posture (correctly, I think), that we can't sit
and wait on VCA.

Clearly VCA has been laying in the cut watching our cake bake. Shit, let 5-10 clinics a week/month start signing up, and let's see if they can find some inspiration.

But I'm with you Wall, I'm not a huge foreplay guy. Lol

And if I don't have it wrong, that horse was transported from Ohio to Missouri?

What's that, 4 states? Committment there! That's not dragging a hound across 4 states.

If this is an indication of the interest we can expect from stakeholders in the horse community, I like our odds!

That's getting the job done, Sir!

I don't know why I have the gut feeling that this may/could have a bigger detonation within horse community.

Horses are equally an investment, as a loved one. Maybe more so. Many of these owners may not have the option to pass on treating their animal.

Ha, not an original claim apparently!

Well, didn't mean to start a "who made the first pizza debate." And that's why I qualified the statement with "unofficial."

Hell, let's hit 'em all and figure out who the real Horsetown, U.S.A. is after we're all drowning in money! Deal? Lol

Fyi, yesterday I started emailing the June 24 Initial Equine treatment press release to various Vet clinics/hospitals in the Norco, Ca area (60 miles inland from L.A.) - which has the unofficial title of "Horsetown, U.S.A."

Rather than sending out tedious pr's, plans, and projections about the company, I felt that 6/24 press release crystallizes everything this therapy means for the horse doc/owner.

Tomorrow, I will email to the W.K. Kellogg donated Arabian Horse Center and Sciences, located at one of the local colleges. Been there several times.

As discussed on this board before, this might be something we can all do on our own, at our leisure, to area Vet clinics, hospitals, farms, stables, breeders, etc.

The press release of the first treated horse allows for this conversation to NOW be had with the equine community, imo. And, unlike dog owners/docs, horse owners/docs will lead with their heads and wallets, as well as there hearts.

Anyway, can't hurt...glta

Hahahahaha.... LMAO!!! Dude, u r hilarious!

At least you will make the time to June a fun ride.

Ha ha ha. Me too. Phuk it, let's throttle down on this topic. Whatever they do, I'm riding shotgun.

But the funny thing is the phrases "reasonably" and "significantly."

These two terms seem to cancel each other out? Because everyone seems to be in agreement, IF applied correctly, the improvement is significant. But, if something goes wrong, then possible safety concerns.

So, STeP approval could hinge on the word "reasonable." Is it unreasonable to expect, through provider training of product administration, radiogel could be a safely administered, standardized procedure (procedure-to-procedure)?

Fair/valid points SC. Appreciate your thoughts friend!

Believe it or not, I'm that unicorn that is not on twitter, facebook, IG, etc, etc, etc. The way this social media thing is going lately, I might get less lonely soon. (laughing)

But look, this is a board for discussion. That's all I'm doing, for whatever it's worth.
I don't have MK's ear and never claimed I did. Others have, however. And as I said earlier, for those that DO, and believe it MAY matter (again, I don't know how he may receive/process information), if they choose, they raise that topic as they see appropriate - on their behalf (as an insider, confidant, CEO whisperer, whatever), or sharing with him board/investor sentiment on this issue.

Like said earlier, MK/Mayo do not need bunch of backseat drivers telling them when to turn. And if some that have MK's ear feel it's a dead or pointless issue, than it's a dead issue.

All I was doing was throwing out yet another daily topic of discussion (like everyone does, everyday). Reading the room, checking the temperature on a topic, and factoring it into current/future investment decisions related to this ticker.

That's all. Not looking to force anyone's hand here, nor Big K's.

Thanks all for feedback and opinions on this!

Glta

And I forgot to add, lastly, at least with STeP, WE ARE ABLE TO FORCE THE MARKET'S HAND TO ADOPT OUR PRODUCT - IMMEDIATELY.

IDE does not do that - unless we have big partners waiting to go.

Good to know your take on this Wall, as one of the go to opinions on this board...imo.

Ultimately, and obviously, this is the company's call. And I (personally) would not presume to get in the way of any planning and decision making between MK/Mayo.

But, if there is someone on this board that has Korenko's ear, and they believe board sentiment on this matter - matters (i.e. (application funding, gauging investor risk tolerance, etc.), then by all means, let's make him aware. I don't know the guy from Adam.

But hey, i'll keep beating that drum - we either have a superior product, or we don't. If we dont, would we rather know in two months or two years. One way or another, we're gonna know.

And really, did the FDA already tip their hand? They said we have a breakthrough, novel brachytherapy technology. What does that mean? Did they tell MK what it means? If he chooses not to go STeP, can he at least tell us what this means?

Novel means new/original. Does it, by definition mean better/safer by FDA terminology? Does the FDA care if something is new/original w/o being better/safer? If not, why bother telling a company you have "breakthrough technology" that's for chit?

So anyway, I'm rambling. You guys get my gist here. If we feel we have the best hand, what is there to fear - other than FDA corruption. And if that's the case, they'll get us at IDE.

Bullet or suffocation?

Sure. To be clear though, long time investors have funded the company's success (or otherwise) over the years through dilution.

In spite of that, those that stayed with the company, I'm sure, believe in the company.

My understanding though from recent posts, funding attempts from investors were rebuffed.

But, if the company determines that STeP is the best path, and needs (and will accept) investors funds to grease the process, I'm sure they will get sufficient investor participation - through appropriate funding channels, of course.

I get it Arch, and I agree with you and rdgl. Who needs/wants more punishment.

But my larger point is, what guarantees do we have a) that we are approved for IDE and b) we see market adoption an c) we see QUICK market adoption?

If there are some big boys laying in the cut waiting to partner with us, then this is a non-problem. And I hope they are there.

But, what if they are not? Then we may have some long, heavy lifting ahead of us after IDE.

STeP, again and agreed, possibly some unpleasant risk there. But what could be the reward? How could our market adoption not be secured with FDA seal of approval that radiogel is THE safest product. Medical practitioners would be almost forced to use our product. IMO

I'm just thinking about the rish/reward. NOTHING seems guaranteed as we move forward.

Appreciate your feedback.

I can appreciate that Rdgl has indicated that they are "evaluating" (or something like that) whether they will apply for STeP. However, after giving it some thought, wouldn't this (applying) be the best play - strategically?

In other words, to receive a designation of "significantly improve the safety of currently available treatments", would seem to get us as close to a guaranteed market adoption as you could get.

I think we all can agree that the physician/medical industry is a slow-moving, risk-adverse monolith (i.e. chicken chits). However, with the FDA seal if approval that says radiogel is THE safest treatment option, it will almost certainly force the market's hand - and lest these risk-adverse practitioners choose to open themselves up to liability for prescribing a product that is KNOWN to be less safe - with possibly harmful side affects.

The only caveat here, however, could be the term "significantly improve."

And I'm guessing what the company may have to grapple with is - to apply and get denied could imply that radiogel is not "safer" than existing products on the market, whereby, in fact, it may only mean that it is not "significantly" safer. But I think we all can assume how investors/traders will interpret, and once again we're on the canvass receiving another 8-count, heading into IDE looking like that last guy/gal, when the lights come on during last call.

Still, the gamble-to-payoff could be priceless when considering unknowns of market adoption. Could be the difference between pushing a rock uphill vs. rolling one downhill.

My guess is the RDGL is seriously considering applying for SteP by this statement in their press release:

"Specifically, we intend to complete additional animal testing to demonstrate the therapeutic benefits of Radiogel™ compared to the current Standards of Care (SOC) for the thyroid tumor type prior to the IDE submission."

Was this latest clinical pivot to enhance the IDE submission? Well, I guess you have to take them at their word. Could this pivot be to establish, unequivocally, that their product is safer than existing technology/SOC - possibly at the suggestion of the FDA? Hmmm...maybe.

Agreed, there are risks with this play, but we will need to face this risk at some point. Is it better to face it down early in the game, or slowly meander through the inertia of market adoption before we know what our true risks will be? A bullet or suffocation?

I say we phuckin' go for it. I'm not old, but I'm not young either. So, if there is money be made here, I want to get to making it. Love my pre-teen daughter, but I don't want her to get ALL the spoils, and all I get is a gold coffin (ha ha...joke)!

Anyway, these are my thoughts. Sorry for long post. Other thoughts welcomed.

Hey Hall, or anyone else that may have knowledge, does the company have a fact or information sheet that's used for their recruitment of vet partners, etc., that can be emailed upon request, or posted on their website for download?

I don't have a lots of time (working man) to "gum-shoe" it, but I'd be willing to drop marketing stuff to local vets here and there when I can.

Figure we're at the point now, where all hands on deck can hopefully help the QB (Korenko) punch it in the endzone with 0.00's left on the clock (borrowed Roofus' metaphor).

Seriously, if they have that, I'll try to do my little part. For heaven's sake, we lost our Vet Chief, so I guess we all had better get to it!

TIA

Gotta admit, i've never seen that type of open disclosure of FDA communication from a company before - that I can recall.

Also gotta admit, I wondered at the time how that may have been received by the fda/rep. Some of these government types can be a pill, for sure.

Interesting Roofus. Hope you're right that FDA rep just wanted to re-establish dominance before making nice again. Dealt with that type before, and would not shock me. He he he (smh)...

(Standing and clapping...and a little weepy eyed emoji)!!

Hang in there everyone. Just told the wife we're delayed til summer, but nothing's changed, and she took it like a champ.

We are all disappointed, but this is still binary: superior technology or not = hold or sell!

GLTA

Ok folks, looks like we're going to have to make our money the old fashion way...EARN IT! No Fear!

Let's go RDGL!

Does anyone else feel like Clark Griswold waiting for that Christmas bonus?

It's rare and I don't see it as much anymore (at all really) - but instead of the customary news release before market, I've seen companies release "earth rattling" news after close of market Friday, heading into the weekend.

This would allow news stories (coordinated or organic) to churn throughout the weekend. And those that got caught playing cute, would boil like frogs in a pot all weekend, and we're served up Monday.

It really is something to watch. Here's wishing...

Oh, wow! Thanks for that scoop Wall. That's news - at least to me.

Gotta admit, a bit of a buzz kill too. I always thought she would be our conduit into VCA, or the like. Not saying that can't happen still, but you're right, what an ambassador to have get us fast tracked into Vet.

Guess our conundrum is, all the years of experience in rdgl is great, but these guys aren't exactly buying green bananas at the grocery store.

Hey, as long as the good doc is teeing this up for a buyout (seems to be everyone's read from today's call), that's not so much of an issue. Still, I'm guessing/hoping there's a succession plan in place.

Thanks again for that insight, Wall!

Have not heard the call/comments, just some of the posts.

I'm sure there is plenty enough enthusiasm to get the word out, but am I out of bounds in assuming Alice Villalobos was brought in for this very purpose? She's associated VCA.

I mean, does our collective voice have a farther, more potent reach than hers?

Frankly, it's always been my thinking/musing to sell off pet side for a fair price ($1B+?), and use that to focus on human side.

Anyway, it would be interesting to get an insider perspective of what Alice's role is or will be going forward.

Champ '21 has my support.

And I hear ya Wall, star alignment on 12/21 a coincidence? Me thinks not!

RDGL could be the chosen one! Ha ha ha

Ha ha ha ha!!! Dude, hilarious!!

Even more hilarious, over the years, I think i've said everything BUT that to my boss!! Hmmm...

Ha ha ha. Thanks for giving me that one to take into the weekend.

This is great and what it's all about.

Over the course of the next week/month, everyone aware of this ticker will have a series of, potentially, life-altering decisions to make.

Get/stay in? Get/stay out? Imagine the potential life-long implications of that decision.

And, for entertainment value, I just can't see uneventful trading as we move toward the presentation, additional information decision, and approval decision.

Potential here just seems to great to watch from a safe distance.

Good luck to all longs and get some rest this weekend - we may need it!

Welcome back WALL. Just what the Dr. ordered!

I read a post this morning with concern of big pharma/FDA possibly trying to "smother this baby in the crib."

That's always been my concern when playing in this space. But as Wrinklesobw has emphasized, that dynamic would seem a bit more complicated, in that rdgl has Mayo riding in their car.

Can you imagine the pre-eminent name in oncology dropping a dime that big pharma/fda is attempting to snuff out a breakthough, life-saving treatment for cancer, to protect business interest? With the new "anti-corruption" administration/sentiment at the center of the recent election?

At best, with Mayo on board, I think pharma would need to do a deal.

Whereas yesterday's action provided some high-anxiety for me, today I feel a surprising calm in knowing that the bets have been placed, the die have been cast, and, as many have said on this board over the years, "we know what we own!"

And next week/month, we TRULY will know what we own.

God I wish I were in the "milly" club like some of you, but I got enough to do some serious damage!!

Good luck to everyone, especially the ADMD era riders!! And Happy Holidays to all!

Got it. Ok, well, hope this road leads to salvation. Glta

Interesting. So, based on the following excerpt, was this new pathway taken at the suggestion if fda?

"If a sponsor has not requested breakthrough therapy designation, FDA may suggest that the sponsor consider submitting a request if: (1) after reviewing submitted data and information (including preliminary clinical evidence), the Agency thinks the drug development program may meet the criteria for Breakthrough Therapy designation and (2) the remaining drug development program can benefit from the designation."

Does this stock have no self control??

"The dog’s owner was passionate about obtaining the treatment."

Wow, the masses are already pleading for the treatment?? This early? Can you imagine if/when we get a couple of successful treatments in humans?

I actually wonder if this 3rd dog was treated for humanitarian reasons, in fact, OR, if they are highly confident of possible treatment outcome and are looking to make a bold statement to different audiences (i.e. FDA, potential partners, early adopters of tech, etc.).

This has just become must see tv! Glta

Excellent nike, thanks. Yeah, they seem to have laid very deep roots in L.A. where i am.

As a matter of fact, when i was with Cedar Sinai, had a couple of discussions with Dr. Barry Pressman (when it was ADMD), and he was always seemingly bullish with the company/technology. His confidence is what's always been my unwavering compass.

Thanks again Sir!

Thanks for that perspective nike, and happy to see your posts here again. Valuable to those like me that pop in and out of this board.

Curious as to what you make of company's suggestion that they received interest about possible combo therapy. But i agree, VCA is where the first tickles could come from. Tia

You're correct WALL on State inconsistencies. Government often times can be a walking contradiction.

As far as costs, i would think/hope Vivos would foot the bill for a few cases to demonstrate they have the goods. And with a few confirmed complete responses, Vivos could request immediate approval, otherwise inform the U.S. government they would need to fund additional cases on an ongoing basis, until they are satisfied (i.e. shit or get off the pot).

As far as catastrophic adverse risks (i.e. death) - well, they're gonna die. Also, there is waiver of claim. I'm sure Vivos' FDA attorney would have provided any relevant counsel before that tweet went out.

I'd be willing to bet that bioethicists and scholars would crawl over broken glass to access treatments like rdgl if they or their young child had a terminal condition and zero options or hope. Kind of like Natalie!

Right to try laws have largely been driven by terminal patients and their families, that have nothing to lose and fed up with the FDA glacial bureaucracy AS THEY DIE. I don't believe it has been driven by deregulation interests, imo.

I wish Natalie and Vivos much luck coming together, to give her an hope and an option other than sure death.

Like.

How long does/can VCA remain on the pot???

Ditto. No one wants a higher share structure, but if the original investment thesis has not changed (i.e. optimized cancer treatment), then a higher share structure can be supported - again, not ideal.

Go Dodgers/RDGL!!!

P.s. WALL/Lucky 7, for the record, you guys looking for cheaper re-entry or permanent sellers? Tia and gltu.