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Pure projection on your part. Grow up!
That’s another “attack”” based on falsehoods. I have politely replied to Dark with my reasoning for including him.
Please don’t speak out of turn.
I can see the posts you like on here. If you support posts calling my “holiday post” a “scam story” etc. then I know what you’re all about. If you like that post then you encourage the poster to continue with his zero evidence “attacks.”
I can only assume you also couldn’t handle my fact based opinions, and that you don’t think I own any shares. As those were the points put forth in his post.
As a moderator I figured you could help them with the morning challenge. Then you’re rid of me once and for all.
I’m curious though. Name one of my posts about Hemostyp and its past, current, or future prospects that you don’t agree with.
Did my post end up being truthful and evidence based after all?
I have always maintained that with the right guidance Hemostyp will get approval.
In contrast, what Trust, DR5, Rodman posts ended up playing out the way they had aggressively hoped for?
Thanks for your time.
Thanks Dark2, you illustrate my point to a “T”. Wavy is always looking to dump on someone. If I’m not around he’ll find someone else. His bringing you up just confirms what most of us think of that sorry individual.
Kinda funny how both you and shoon bring me up in conversation today. Especially since I have not made a post in probably months. You feel that I am pumper on what grounds? Because I have said in the past that I don’t typically agree with the majority of your post? While I typically agree more with Trust & DR5 on things , I think anyone that has an axe to grind would be shoon. His nonsense that he puts on here 5x a day is just ridiculous.
I have been long on this stock for years and constantly add to my position.
Wow fighting in the pits at least the wrenches were still in the tool boxes - No one can predict a timeline on a finish there are lots of variables (flat tires, terrain, weather, engine trouble and the worst getting lost). 101 - The time stops at this stage and the FDA has the pleasure to call for a restart. This team has been low on cash and experience. They have pulled off what the big boys with mega sponsorship have a tough time doing. Mistakes get made but is behind us now. Building in the USA is a good thing for the officiate to oversee/inspect. Hopefully they have done all the needed safety test runs and addressed the risks that the FDA asked for. This is a grueling technical race and takes time - White Lion cash is coming to help bring the big guns. Just spotted their truck load of cash outside of Barstow!
Viva Las Vegas
For your reference:
Waverunners
Re: trusttheman post# 11291
Saturday, 04/01/2023 2:32:20 PM
Sorry for slow reply. I’m only allowed one post a day so won’t be checking in too often.
They’ve had a consultant for a long time.
Somehow he didn’t know that all of this testing had to be done in order for the PMA to progress.
If I knew- please tell me they knew.
If they truly have full access to the consultant and he didn’t advise UHP immediately upon being contracted -and learning that UHP moved factories after human trials.- that they MUST produce USA product, then yes the consultant is “that stupid to make mistakes like this.”
Second inconsistent messaging:
Originally RCA advised that if first test is successful , then within a FEW days the PMA would move forward.
Apparently Test was a success! But then new Test is ordered- why?
They never mentioned this before.
Shouldn’t experts have known this would be needed and if they did why did they say “a few days” originally???
Reason - they screwed up the test process.
Then when they do a complete test the true results come in.
You will know the true level of incompetence when we are still wondering what stage of the process we’re in as we enter 2024!
I ASSURE you.
Again, I have nothing to hide. All posts are for public consumption. Unless you can actually reference a post or be accurate with your quotes please stop messaging me.
Just saying “long time posters remember” isn’t evidence of anything.
“…built a plant?” No I wouldn’t say that. they have contract plants.
Their original PMA did reference an agreement to manufacture Hemostyp from start to finish at one plant. That PMA failed as the Hemostyp used in Human Trials was Asian. And it turned out UHP hadn’t actually manufactured American Hemostyp to spec when they submitted the PMA and had to scramble to get new product at the same specs as Asia. I referenced this blunder many times.
My famous Memorial Day post was never positioned as fact, but rather, “a feeling.”
It was my opinion and I’m entitled to it.
Nah Wave. You're wrong. Long time posters here remember what you said. You said they shouldn't have built the plant over here. That delayed things. Fact. They were told to do that by the FDA. They had no choice. It was the only way they could have gotten FDA approval. We all know they never got rid of the plant overseas. That wasn't my point. My point was you were complaining about how they should not have built the plant over here. Yes, you said that. Most of the things you say I don't pay attention to. That one I did because it was completely wrong.
You have yourself a great day. Good luck with your research.
Also, if you can send trust my earlier reply I’d appreciate it.
Where is this frikkin bandage plant? Exact name and location? This is the biggest crock of bullshit I have ever heard. A fictitious bandage plant for a fictitious bandage. I realize a dude named Beplate bought a crate or two of the cheapest Chinese bandage money can buy over a decade ago. Since then? This is hilarious bullshit. Here, I found a serious use for your bandage. The only problem is dark2 doesn't have enough motivation to do any actual business:
https://owenandsage.com/products/pretend-play-bandages
You own it like the cheap suit personality you are.
And the “attacks” continue.
I believe you’re in your 60’s. Come on, do better.
They did keep their plant “overseas.”
What’s wrong with you? This is a fact.
People send you my posts? That’s weird. They should respect that you don’t want to see them. Otherwise, you wouldn’t have me on ignore.
Do they cut and paste the whole post?
You got a lotta room to talk, jerk. I don’t think I’ve ever encountered a bigger egotistical, blowhard with so much hubris that you’d give tRump a run for the crown for “Buffoon of the Century”!
Classy Dr5. It’s a shame you are so defeated that all you have is toilets and name calling.
Good luck with that in retirement.
I don't read your nonsense Wave. Sometimes people send it to me. Like I said. You're not a shareholder. So, you have 24 hours to send the entire board proof that you own shares of this stock. You won't because you don't own any. I remember back in the day you were spouting nonsense about how the company should have kept the plant overseas where if you did any research you would have known that the FDA was never granting approval to the company unless the plant was in the U.S. One of many things you haven't gotten right.
Hi Rodster. I thought you claimed to be an accountant? Dust off that calculator and do the math. Once completed let me know where you think my numbers were off.
I look forward to the results of your audit.
I’ll keep looking for my “FDA Manual” you referred to.
Do you want one that is more specific than the link UHP provided?
And remember it’s — You’re not your.
“… your a LIAR!“
Well, now that I’ve set up shop in your deranged mind, I noticed there’s a toilet here. Think I’ll use it! 💩
As always, I respectfully challenge you or anyone else to find even one deliberately inaccurate statement I have ever made on this board.
If you or anyone else can find a post where I deliberately mislead readers or posted falsehoods that would have lead to my personal gain from UEEC I will gladly stop posting.
Note, you can’t just make things up because you don’t like my tone or viewpoint. You will have to show that I lied due to this axe to grind or desire to pump.
I have never made up timelines based on weak facts, researched the wrong PMA process, or asked others to sell all their shares.
Remember, like all posters, I’m entitled to my opinion.
You have 24 hours.
Here’s your team of investigators:
The Pumpers
DR5
Trust
Rodman
Dark
The Bashers
Zorax
Shoondale.
I’m sure if you can all get together and put your differences aside, it should be no problem to find posts that I was deliberately making stuff up to either scare off shareholders (pumper stance)
Or work to artificially enhance the pps (basher stance)
Amazing that 5 posters have such opposing views of the exact same posts.
Well, I think it’s very obvious at this point that Wave was either fired by the company or has a very bitter axe to grind against somebody in the company. There is a hatred that he has for the people that run this company that goes way beyond just stock waiting frustration. It’s why I try not to read any of his stuff any longer and I can’t take him seriously. When you reach the point where he tries to defend his holiday stunt that he pulled there’s something seriously wrong in his head. I stand by what I’ve said for over a year now that he doesn’t own any shares. However, he will continue to come here just like two or three posters on every single board on this site and do nothing but try to create doubt and panic. If he believed 25% of the things that he says about this company, he would never come to this board. Mr. Hubris would be on different boards with stocks that he actually owns.
wow I have cooked Julia Childs French chicken recipe for years and is best to add some mushroom's and rice. nice high protein dish before a race. sad, not a good comparison - seral killer versus someone trying to make us money. you might need some couch time and it is okay. looks like Doug is still dancing.
We all like the adrenal feeling of going fast but the next two stages are very technical and the slow is fast to finish rule needs to be used! You don't want to DNF or get off the course and get lost here since we are in the lead with a big payday ahead. No Evel Knievel stunts (man he had balls) and look he had his lucky rabbits foot.
I think we need some WD40, there's a winning noise coming from somewhere. Yep Visionary race team owners do get fined. I also get speeding tickets when I am caught going to fast. Thank god it is the good old USA and we have operating rules! Elon Musk's settlement resolved the SEC lawsuit accusing him of defrauding investors. Under the agreement Musk and Tesla each paid $20 million in fines and he gave up his role as the company's chairman . How many millions did he make for investors (11,660 %)? Makes Beplate's fine look like he ran over a official's foot. Time to do some dancing Doug!
Get this SHIT!!!! DONE!!! BY END OF SUMMER!!!
Utter bullshit: again PMA con game in a nutshell:
We are in race 3 and just finished stage 3 of a 6 stage rally race, just have to clean the windshield, change tires and gas up! Look 2 time Dakar Rally winner Ricky Brabec is giving the team some racer support.
Races for the FDA’s review process for premarket approval applications (PMAs) involves several steps:
1. Acceptance Review: The FDA checks if the PMA submission is complete and contains all necessary information. If deficiencies are found, the applicant is notified.
2. Filing Review: The FDA evaluates the PMA for filing. If deficiencies prevent filing, the FDA issues a “Refuse to Accept” letter, providing reasons and guidance.
3. Substantive Review: The FDA conducts a thorough scientific review, assessing safety and effectiveness data. If deficiencies exist, a “Major Deficiency” letter is sent.
4. Panel Review: An advisory panel of experts evaluates the PMA. Their recommendations guide the FDA’s final decision.
Stages for the Substantive Review race phase of the FDA’s premarket approval application (PMA) process is a critical step. Here’s what happens during this stage:
1. Data Evaluation: The FDA assesses the scientific data provided by the applicant. This includes clinical trial results, safety data, and effectiveness evidence.
2. Risk-Benefit Analysis: The agency weighs the benefits of the medical device against its potential risks. They consider factors like patient outcomes, quality of life, and safety.
3. Deficiency Identification: If any deficiencies are found, the FDA issues a “Major Deficiency” letter. This outlines specific areas that need improvement or clarification.
4. Communication with Applicant: The FDA engages in dialogue with the applicant to address deficiencies. The applicant may submit additional information or make necessary adjustments.
5. Expert Review: The FDA’s experts thoroughly evaluate the data. They consider the device’s intended use, patient population, and clinical context.
6. Decision: Based on the review, the FDA makes a decision on whether to approve the PMA. If approved, the device can be marketed in the U.S.
FORM 8-K filed for more sponsorship funding with White Lion Capital. More cheap stock purchasing opportunity for them to help UEEC on the FDA response. Man these kids are going to get Crazy Rich! This stock should be shifting to 3rd gear but looks like White Lion has installed a restrictor plate. Time to pit and get more cash
How about forever Rodman? With 40 deficiencies from 2017 (that's how long you've been filing PMA's) and no real progress; you're staring at bagholding for the rest of your life. But hey, you do get to watch your stockbroker CEO churn shares to feign interest in this POS, as you bullshit yourself about it for eternity.
No documented authority for what you have stated unless you confirm you have the FDA manual, worked for FDA as an examiner or any confirmation of what you state as truth or NOT!
Othewise your a LIAR!
$5-$10
So, now that everyone realizes that there is a Within 180 day clock. And the PR clearly references it in terms that most can understand.
I will break it down before someone else tries to manipulate the information.
180 days started approximately Mar 21.
180 days stopped approximately June 18
That’s approximately 89 days into the process.
Careful now, this is where others will try to twist the information.
The clock WILL NOT start upon resubmission. It will start once the FDA states that all the information is accurate, and all the deficiencies have been addressed. If FDA finds the resubmission acceptable and moves it to full in depth review, the clock will start again. At that time there will be 91 days on the clock.
UEEC is almost in the home stretch just a yellow flag -- Time to pit for some PMA tuning with help from their consultants and some officiating calls with the FDA over the next two weeks. It is going to take some time to answer all 40 deficiencies since they are a small company, they want to get this right to get on the podium waving that approval letter. They want the big payout for the team and stock holders. It is tough for the big Pharm F1 teams to go through the heavily scrutinized FDA PMA process. Then it will be time to do some shredding!!
Only 40 deficiencies? This PMA bullshit has been going on since 2017!!!! That is 7 frikkin years!!!! The best question would be; was that also 40 deficiencies in 2017 and not a damn thing has changed since 2017? Maybe, just maybe, if stockbroker Thom (spearhead of this stock scam) gets cracking, you can get that down to 39 deficiencies in another 7 years to welcome in the third decade of this charade. And how many silly aliases will Rodman have by then? This is a laughingstock.
It is not standard for every company to receive this letter.
What are you basing that on?
They issued this letter because the application was below FDA standards. Read the FDA notes below.
The CEO and the Consultant submitted an application with 40 points of concern.
———
FDA will refuse to file the application for substantive review if a PMA application does not meet a minimum threshold of acceptability. If the information or data are presented unclearly or incompletely or are not capable of withstanding rigorous scientific review, FDA may consider the PMA incomplete and not file it. If FDA refuses to file a PMA, FDA will notify the applicant of the reasons for the refusal. This notice will identify the deficiencies in the application that prevent filing and will include the PMA reference number. FDA will advise the manufacturer of what information must be provided, or steps to be taken, to make the application fileable.
So now you believe there is a WITHIN 180 day review period?
I agree that this proves once again that my assessment of the PMA process was and is correct.
The clock is now paused.
It will resume when the amended file is submitted.
At that time I will not have to debate you, DR5, Rodman or anyone else that thinks they know the system and makes up unreasonable timelines. Especially, if they “research” the wrong process.
For those that don't remember this company started out as a business development company. One of those was Shelby Supercars (SSC) Tuatara 331.15 mph. do you I wanna go fast!
The height of stupidity is most clearly demonstrated by the individual who ridicules something he knows nothing about. Albert Einstein
Nice easy to read article that may help on the PMA
https://www.drugwatch.com/fda/premarket-approval/
This snippet from the article was interesting
"But as rigorous as the process is considered, manufacturers virtually always get the green light if they get over the first hurdle of persuading the FDA to accept and file their applications. According to one analysis, nearly every premarket approval application accepted by the agency in 2015 was granted — a 98 percent rate. As of March 2017, the rate was 100 percent, according to FDA data."
🏁
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