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I know and I don’t know if saying that this could have been handled a lot better is completely accurate… but I think we all think things could have and should have been done a lot better.. cleaner and more efficiently… nonetheless… it actually does take around 6-7 Years to get the approval that we are looking for… maybe not for Johnson & Johnson because the wallet is a bit bigger and a dedicated department to getting this done comes in pretty handy.. Time will tell all
Going on 7 years waiting for news haha
It’s been too quiet for too long. I would say by the end of July we definitely hear some news. Hopefully the news we’re waiting for.
I guess you have a point.. oddly when I asked the paid bashers that we know are exactly They paid to do a job … but any question I’ve asked goes unanswered.. I guess if they were to lie it would be committing a fraud… but to continue to post extremely old PR’s and news isn’t.. As I say… It Is….. What it is
So basically, if people are free to post their opinions without being called “a short, a paid basher, a keyboard warrior, a non shareholder, a Doug hater,” or any other false accusation a so called long may regurgitate, we should be good to go.
No one should be offended when asked to elaborate on a statement either. He/she can ignore the request(which speaks volumes) or back up the statement.
Maybe I’ll sound foolish or gullible.. although I’m not trying to.. but I would just prefer that yes we base our statements on facts.. we base what we say on what can be backed up.. if we state opinions it’s fine as well but let’s say that is solely my opinion..opinions can be correct some of us have been here plenty long to be able to read between the lines.. that being said I wish our board could maintain a proper and productive atmosphere where we discuss things intelligently and in a dignified fashion… my losing my mind aside lol
You were suspended for your comments on here, and once again give advice:
JR
“… The reason I said to you I will do what whatever I want is because well I will :) and you my friend like to speak in a condescending tone and perhaps you need to get a hold of that edge that you seem to think you have..”
Jimmy, I’m not asking you to listen to me, I am hoping that you will listen to yourself: …
JR
“ I’ll do whatever I want and I obviously don’t need your permission to do so.”
For me, as a “real long,” I will continue to call out the other “real longs” and “bashers” alike on their lies and lack of ability to see both sides of a debate.
That’s not “condescending,” it’s just logical conversation. If the poster can’t back up bold statements with facts then so be it. No problem with me. That way the lie is exposed and the debate may or may not continue.
You can ignore whoever and whatever you like.. Wave asked me to engage you on a topic I chose not to do so.. I made my own statement on my own opinions.. You do as you wish my man
Ignore button Jimmy and Chris. A wonderful feature. Wave and Shoon are not shareholders. They have done nothing but try and lower the stock for years. These 27 surgeries are a disgrace and is exactly the type of thing that got half the FDA fired. Just to get to clinical trials for a class 3 product is an enormous and costly undergoing. The fact the company did that and was declared superior is incredible. Now, four years later the unethical and corrupt FDA acts like they never did that and cries for a do over. Crooked on the highest level. The FDA has become a disgrace to this country. Lap dogs for major pharma companies. Nothing more.
My friend you misread me.. you are also misreading my post.. by saying we and I do mean a lot of us not you and I agree to disagree was just my friendly free advice to whoever wants to listen and understand that we really are not advancing much by arguing amongst one another.. We (the longs) have to be delusional to own this stock and argue what a piece of garbage it is.. From what I understand some on here own pretty substantial positions but no matter what the size of your position if you have given up on the company And management and truly feel all is lost.. Sell.. Move on. Why hold and bash this I will never understand..
I would like to take a moment to address the beginning of your post… The reason I said to you I will do what whatever I want is because well I will :) and you my friend like to speak in a condescending tone and perhaps you need to get a hold of that edge that you seem to think you have..
As far as the keyboard warrior statement.. In my opinion a keyboard warrior is herb.. a wanna be tough guy.. a wanna be bully.. Me lol I’m not a bully.. was when I was a kid and I’m ashamed to think that I broke peoples chops and maybe even made them not want to come to school.. I think that was a very brief period as a foolish boy… As I became a man I despised bully’s and wanna be tough guys.. and I’ll elaborate on my statement.. If I were to see someone getting bullied I would try to stop it.. if I knew more about the situation and knew that the bully is a notorious bully I would then Give him a beating in front of the person he’s victimizing and then take that person to a nice lunch.. that’s me.. the anti bully.. hopefully you now have a better understanding of.. have a wonderful Sunday
Jimmy, you just can’t seem to get out of your own way.
First you tell people what and how to post.
“ Enough with the back and forth guys.. some of us agree to disagree let’s leave it at that.”
Then your next post starts with:
“ Actually Wave I’ll do whatever I want and I obviously don’t need your permission to do so..”
Take your own advice, let people post what/how they want, and don’t get so offended if you don’t agree.
This is a message board, nothing is verifiable.
Including your bold statements of “going straight warrior”. Seriously?
Here’s a challenge for you:
Ask trust to prove when “ The FDA stamped them superior to the pile of garbage that is the industry leader.”
Or since you’re such a fan of his, you prove it for him.
That is more of a lie than what I see the “bashers” posting lately.
For me, I’ll call out anyone that posts inaccurate info. And as you have seen, I also despise bullying. So I call you out as well.
Chris anyone who can be so offended by what I said about a person who stalks this board day and night to only bash and continuously post terrible things about a developmental company from 7 years ago over and over and over has but claims to be a long…. I mean I don’t know what else to.. as far as a keyboard warrior.. lol farthest from it… I live in NJ I can be in NYC In an hour top.. I only wish I could have the opportunity to sit eye to eye.. face to face.. with someone who bashes our company constantly but has never admitted to owning shares or a position whether it be long or short.. I’ll go straight warrior not keyboard warrior and would love to have a cup of coffee to discuss matters.. differences??? Yes we can agree that we’re looking at the the glass from different positions I’m for that.. but I stated my position a long time ago and continue to do so.. I believe in our product it smoked the competition previously and will continue to do so.. we will get to where we need to be hopefully sooner than later.. I appreciate you speaking for me Chris you’re a good guy always a straight shooter.. hang in there our time is coming
I didn’t report him. I was hoping it would stay up long enough for members to see what a disgusting mind he has, behind all the “keyboard warrior” accusations he’s always making.
But whoever did report him should be commended.
And I'm guessing you're the one who reported him or keep reporting people
Actually Wave I’ll do whatever I want and I obviously don’t need your permission to do so.. My post is to avoid things like this.. I’ll give you credit yes I unleashed but what I unleashed was overdue to a putrid individual that just wants to bash a company with old PR’s and avoids any response on a valid legitimate question.. as far as what I wrote I am sorry if I offended your virgin ears but I thought we were all big boys and big girls on this page.. not justifying the actions just speaking truth as to what I think of the individual or even individuals that are in the same class as that person… maybe you will understand that this is a classic case of keyboard tough guy and a bully that wants to sound credible but has zero credibility because he will not reply to any questions that are sent his way.. go back on my messages I’ve asked him legit questions and simply does not reply.. so yes my opinions on him stick, they stay in place and as far as I’m concerned are valid.. Putting my prior war crimes aside I think my last post was a solid piece of advice
Jimmy, you were suspended for unleashing the most repulsive, disrespectful post this board has ever seen. Please don’t tell others how or what to post.
Enough with the back and forth guys.. some of us agree to disagree let’s leave it at that.. But I think we all should agree that our lovely CEO needs to update us with some news that isn’t vague and to the point and accurate and has a time frame that is also accurate and acceptable
I love how Trust tries to pretend that he doesn’t read my posts and has me on ignore.
Then brings on 2 posts of rebuttals as soon as I reply to Chris.
“ You talk discrepancies. What a bunch of nonsense.”
Think about it like this using common sense. Over four years ago the FDA gave the company specific instructions on how many surgeries they wanted and what types they wanted. The company followed orders. The FDA stamped them superior to the pile of garbage that is the industry leader. Clinical trials over. I repeat. Over. Why the hell are we doing clinical trials again over 4 years later? I tell you why. Because the FDA is incompetent and corrupt. It's like when you were little and you played a game and somebody lost and they said, doesn't count, do over, the rules aren't fair. Over four years later the FDA said, nope, clinical trials and our superior rating doesn't count. We are changing the rules. They waited right before the company was going to ask for approval. On what planet is that the companies fault? On what planet is that not total corruption by a corrupt government agency? You're blaming the company for something they shouldn't have to do! Clinical trials were fn over 4 YEARS AGO. The FDA ignored what they did. Why? Because of the very reason half of them got fired. They are nothing more than a corrupt lap dog for the major pharma companies. Nothing has changed with this new guy in charge. You talk discrepancies. What a bunch of nonsense. I repeat. Clinical trials are OVER. They were OVER 4 years ago! The FDA said those never happened. It's so corrupt it's pathetic.
Again, that’s nothing but total bullshit. You are assuming that the FDA is asking legitimate questions or they are finding legitimate things wrong. If you talk to any person who has dealt with the FDA a lot. Every one of them will tell you that the FDA is completely and totally corrupt. I love how you people ignore how the FDA had four fucking years to ask for 27 more surgeries and did absolutely nothing. They did it deliberately to fuck the company over. I also love how you ignore how the company was approved to do at least 270 surgeries yet now can’t get approved for 27. You also ignore that half the FDA got fired for a reason. You people are living in a fucking dreamworld if you think the FDA is competent and is ethical.
This site needs to move faster with posting.
Precisely. It's easy to point fingers at the FDA. But people on this board tend to overlook that the company keeps making it easy for the FDA to not move fast. The company needs to quit giving the FDA reasons to stall.
That’s easy Chris, no conspiracy theories here. This is the least proactive Management team around. They submit applications full of deficiencies and then act to rectify those deficiencies while falling short on other areas of the applications.
I have commented for years, that even their PRs are full of vague statements, which often left shareholders feeling “we” were close to approval. This remains true today.
The most glaring example:
They didn’t submit a PMA amendment to the FDA when they changed their entire manufacturing process, from what was used in the trials.
I brought this up repeatedly, only to have Trust or another uneducated poster claim I must be a short or something ridiculous.
Not voluntarily submitting that amendment and stubbornly trying to push an incomplete PMA through the system was foolish. This set this whole process back a minimum of 3 years.
But you don’t have to trust me, just read the PRs (as vague as they are ) from 2022 onward and you can see how all of this played out.
Ignore him, Chris. He’s not a shareholder. I’ll tell you something there’s a few dumbasses on this board who keep acting like the FDA knows what they’re doing. At one point people in our company were teaching the FDA what to do with their product. That’s a fact and if you talk to the right people, you would know that. That just goes to show you how clueless the FDA is.
So who the f*** do you blame for this b******* happening all of a sudden this b******* has to stop someone needs to be hung for this
But Trust has repeatedly blamed the CEO. He is only changing his tune because I called him out repeatedly. Now he is blaming his other punching bag for delays - the FDA.
When share price goes down he blames the corrupt SEC, or even IHUB posters.
In real life he blames his Boss for his poor performance, coworkers for creating a bad work environment, Fruit Loops and Budweiser for his enormous belly. Etc. etc.
Ask yourself this GetRch. The company was previously approved for 270 surgeries. Now, they suddenly are so stupid they can't get approved for 27 surgeries? Which they should have been asked for over 4 years ago? Bullshit. You're smart enough to see what is going on here. I've had plenty of issues with some things the company did. This is not on the company. There are lots of things that are public knowledge if you know where to look. It's not rocket science.
how do you know what questions were asked? Insider? No PR has released the questions asked. Based on the public information provided, the FDA review process caught data issues. That's 100% on Brian and team for not reviewing themselves as thorough as these FDA idiots you keep referring to.
I disagree. The FDA came up with some things they thought were incorrect. The questions they asked to the company were idiotic and made no sense at all. They weren't even logical questions from what I heard. This has nothing to do with Brian. This is simply the FDA coming up with bullshit that is causing delays. Brian and the team surely made some mistakes. This is not on them. This is the same shit that has been going on with the FDA for decades. They suck off major pharm companies and everybody else who isn't one gets the shaft. Anybody who believes the FDA isn't corrupt at this point is clueless. Half of them didn't get fired because they were good at their jobs and were honest.
It's real simple. There was a documentation discrepancy found when reviewing. That was clearly stated. This had nothing to do with the FDA. This was documentation by the company / study teams that entered the data. The FDA asked the company to justify. UEEC did. That wasn't done until until the last meeting they had with FDA. Now, we are waiting on FDA again.
Honestly, had Brian and team done a better job dotting i's and crossing t's I believe the IDE would have been approved already. We can blame the FDA all we want. However, Brian's lack of knowledge on running a medical company is what is causing all the delays here, NOT the FDA.
Until IDE is approved by the FDA, there will be no progress and pps will be what it is.
New head of the FDA has been a complete failure so far. Biggest problem with the corrupt FDA is they stick their tongue up the ass of every major pharm company and blow the rest of the companies who are smaller off.
New head of the FDA has been a complete failure so far. Biggest problem with the corrupt FDA is they stick their tongue up the ass of every major pharm company and blow the rest of the companies who are smaller off. They put no priority on the product or drug being developed. This company has a game changing, medical world product. So far all the FDA has done is everything they can to not get it out to the public. Disgusting. Not surprised though. The people working at the FDA don't care about helping people. They care about themselves which is why half of them got canned.
If true, which of course is unverifiable, how would this ever benefit shareholders?
More pointless drivel.
Keep in mind the prior reviewers who I understand opted to retire upon the Trump administration offer may be working the UEEC case once again. What are you worried about shoon boy? You don't have any skin in the game!
$5-$10+
1. Failure to submit an IDE application to FDA and failure to obtain FDA approval prior to beginning an investigation for which FDA’s approval is required [21 CFR 812.20(a)(1) and (2).
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
2. Failure to ensure proper monitoring of the investigation [21 CFR 812.40].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
3. Failure to secure clinical investigator’s compliance with the signed agreement, the investigational plan, applicable FDA regulations, and any other conditions of approval imposed by the reviewing IRB or FDA, or if compliance could not be obtained, failure to discontinue shipments of the device to the investigator and terminate the investigator’s participation in the investigation [21 CFR 812.46(a)].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
4. Failure to immediately conduct an evaluation of any unanticipated adverse device effects and failure to report results of such an evaluation to FDA and to all reviewing IRB’s and participating investigators within 10 working days [21 CFR 812.46(b)(1) and 21 CFR 812.150(b)(1)].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
5. Failure to maintain accurate, complete, and current device shipment and disposition records [21 CFR 812.140(b)(2)].
If you have any questions, please contact Alejandra Cambonchi by phone at (301) 796-0552 or email at Alejandra.Cambonchi@fda.hhs.gov.
Sincerely yours,
/S/
Soma Kalb, PhD
Director
Division of Clinical Policy and Quality
Office of Clinical Evidence & Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
So agreed and in this regard we can speculate that those previous reviewer(s) originally charged with the UEEC PMA/IDE review have been called back to arms after their release from employment or election to retire from service and are now proceeding forward. You bet the reason for "As of the current date, the FDA states that its review of the company's response is ongoing."
$5-$10+
Nothing will happen until the FDA gets off their ass and does their job in a competent fashion for once. Half of them got canned. Nobody knows whether that is good or bad. Short staffed is bad. However, the clowns that got fired probably were either corrupt or didn't do their jobs properly anyway. The company never should have been asked for those surgeries 4 years after clinical trials. Corrupt beyond belief. That screwed the company over big time and is the very type of thing that should have gotten people in the FDA fired. However, the financial backing of the major investors in this company because of the dominant product is strong. The FDA will not succeed in getting this company to throw in the towel. So they might as well do what is right which is the approval of this product.
You can't look at the technicals of this stock and make any guess that will be remotely accurate. This will continue to bounce a bit but not rise much at all until there is fundamental news that they can proceed with surgeries. Once that happens, we should expect a rise to a new level and see the same behaviors we are seeing now (e.g. it bounces between 25 and 40). Once the fundamentals come in. we can then start to see technicals respond (new people jumping in, shorts figuring out how to save their asses, etc.).
Honestly I don’t know where the price should be at this point.. no idea. No clue.. however my friend made a statement and sounds pretty strong on his statement and I do know what wash trading is I would just like for him to elaborate on it so I better understand what possibly as you put it the conspiracy is .. as far as your question where our pps should be I don’t think we can intelligently speak on that right now… however we did rise to.27 and I would muck rather see us there.
Why does it have to be some big conspiracy? Everyone is always looking for an excuse on here.
When the pps drops a bit it’s MMs or Shorts etc. Never “ hey this PMA has been in limbo for 6 years, maybe the pps is going down naturally. “ or “ I believe in the product but the latest PRs and disclosures have been pretty disappointing. “
Then as soon as pps goes up a bit all the irrational longs are guessing that “PR or guaranteed approval is imminent.”
Do you honestly think there is a current reason that this stock should be going up right now?
So my question would be obviously who is doing this?? The market makers?? The shorts?? The longs?? The pumpers?? The dumpers?? I know you and I don’t see eye to eye and that’s fine.. we agree to disagree.. but I would like to understand better what you’re saying because I’ve been in the market for years and of course we see things and we see manipulation with these penny stocks.. but what would be the agenda here other than to make it look like there is action?? I’d like to hear more.. thanks
Volume has been up since the big sell off that pushed pps down.. we need some news to bring the in aggressive buying
Thom currently earns(questionable) $16,500 per month.
Hopefully, he doesn’t try to siphon off some of the $13,750 per month Heaton was earning.
"Where as the FDA is fucking useless, they do no work. There is no reason for any of those people to even get paid."
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