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What?
My 2023 post ruined everyone’s long weekend.
Pretty sure that would mean that everyone is listening.
Also, like all my posts it was accurate.
I stand by the statement that I believe they are cutting and packaging in USA with Hemostyp made elsewhere…likely original China plant. Though UHP has never said that.
Here’s my awesome post you’re always whining about.
I have just reread it. Thank you for reminding me of its absolute genius:
Waverunners
Re: None
Friday, 05/26/2023 1:01:58 PM
I have a feeling we will soon learn that UHP has abandoned their quest to produce Hemostyp in the USA. Hence, the emphasis that now the Cutting and packaging is happening in a USA plant, not the manufacturing.
Could be wrong (doubtful) but Either way, using two facilities seems like a logistical nightmare for a company like UHP and it is my assumption that this is a huge part of why the testing has returned unsatisfactory results which they essentially admitted.
These changes wreak havoc on the original PMA and were the reasons I stated repeatedly that major amendments were needed.
Just for weekendBBQ UEEC talking points. Hot take predictions:
$2-3.50 With PMA
12+ months to PMA decision
24 months to acquisition.
In the mean time UHP May be presented a low ball offer of approximately $0.48.
This excludes potential pump and dumps.
Have a tremendous weekend. And RELAX a little.
I’ll use a story from Trust’s life to help explain that there’s no fast track for failing the first time.
When young 12 yr old trust was entering 3rd grade for the fourth time, his parents asked the teacher “how long will it take this year?”
To which, the teacher replied “Trust will have to complete the entire year . No short cuts.”
Of course the parents were outraged. Expecting that since Trust already spent 3 years failing that he should get preferential treatment.
“I’m sorry, but Trust’s inability to complete the required learnings does not grant him special treatment. Believe me, I want him out of this class more than anything. But, we must follow the guidelines. “
Long story short - Trust never did get out of that class. He eventually grew to be an uneducated Trusttheman.
Hopefully the same fate doesn’t befall Hemostyp.
“ The fact that he disappeared for a long time when he predicted Ueec would complete the PMA in October tells you all you need to know”
You got me. Yes I thought they could actually complete and submit a PMA amendment in a timely manner. Especially when UHP wrote:
July 15, 2022
we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
So ya you’re right. When a CEO states “in the coming weeks”. and the full application isn’t submitted for 21 months even I missed on how useless this company is at working “expeditiously”.
So you’ve exposed that when the CEO doesn’t complete his tasks as he says he will, it’s my fault.
And a logical (in Trust’s world) conclusion is that this would make me a short.
And by stating accurate factual FDA information I am creating a panic.
Well, that all makes sense. Good work.
Pragmatic, you nailed it here. You were accurate and strong in your opinion.
Then you folded like a cheap suit.
Why would dr5 ever ever ever have more insight than what you offered.
He took your accurate information and ran it through the dr5 make believe machine.
You were right. He (of course) was wrong.
Hey GR$. Nice article. However it was focused on a range (qfm/ qih) of products that have little in common with Hemostyp.
That being said it does shed a little light on timelines.
You should always read for what is real and not just what you want to interpret. Fake DR5 wouldn’t look for reality so he is a very poor reference. Like with all dr5 diagnosis you should always ask for a second opinion.
Here’s the articles concluding statement:
Conclusion
So there we have it - it takes on average between 154 (for QFM) to 201 (for QIH) total days to receive a 510(k) decision for SaMD products,
Trust, you don’t have to say someone told you I posted. You sound like a little schoolgirl. Man up. Let’s face it you love when I post. Deep down you know DR is a complete fraud.
Do you guys actually private message each other when I post? Creepy. Again, a bit schoolgirly.
Just take me off ignore and bask in reality for a little while.
trusttheman
Re: DR5 post# 7959
Thursday, 12/02/2021 7:48:35 AM
I actually wanted to hear what Wave had to say. The timeline he gave which so far has been accurate was completely opposite of what a few of us were told…..I wouldn't trust the FDA on any level. That being said, it would be interesting to see what he has to say. Also, why he suddenly came back. Maybe he feels conclusion will be coming soon.
Complete manipulation of the information DR5.
The guidelines are clear. You have simply pasted what a simpleton wants to see. So of course Trust is following your backward logic.
Do real homework and you can see from the FDA website:
FDA Action On a PMA
Within 180 days of the date of filing of the PMA (§814.40), FDA will complete its review of the PMA and of the advisory committee`s report and recommendation and issue one of the following:
an approval order under §814.44(d),
an approvable letter under §814.44(e),
a not approvable letter under §814.44(f), or
an order denying approval under §814.45.
I have never been wrong regarding the Approval process. Not once. Never.
You two dodo birds have both been wrong, non stop for 6 years.
I stopped posting because nothing changed. I came back after the PR and waited for fake DR5 and Rodster to start posting ridiculous timelines.
If you are joining their band of dopes, then I will gladly prove you wrong again also.
It’s been 6 years straight.
For the new readers, Trust once claimed human trials would take 2 weeks max.
Of course it took over 12 months and 24 to analyze all the info.
That’s just plain old Roddy the Rodman saying crazy Rodster stuff.
Their recent PR trumps the 2021 PR.
This is a brand new application. Estar or not, they are at step 1 in the process.
PMA has been submitted, they will now wait to see if the application is filed for further review.
They even included the FDA link in the PR this time so you can follow along with the steps.
If it accepted for review the wait will be up to 6 months.
No debate, FACT. As always.
No timelines, due to no meaningful communication.
Last PR with any substance was July 2022 and they have completely failed to meet any of the goals set forth at that time.
All subsequent PRs have been further evidence that this management team has failed shareholders, the FDA, and anyone else that has invested their time or money in these guys in any way.
The only guarantee right now is……
It’s Payday for Thom tomorrow. Another hard earned $15,000.
At this point I just want a PR. Thom has reached a new communication low this time around.
Good news, bad news or further delays, investors deserve to know.
Most here know my contempt for Thom. However, I still thought he’d follow up by end of July at latest. The 20th would have been admirable.
You’re right. I really got sucked in.
All three are now on ignore.
I pride myself on intelligent debate and guiding others to a higher level of PMA knowledge.
By debating with these lost souls, and using words unbecoming of educated debaters, I let myself and this board down.
As two new moderators, do you guys delete your own posts after learning how stupid they are, or do you get the other guy to do it.
Either way, your idiocy is clear from the posts that remain.
The debate is over and I won. Look at the post I replied to idiot.
In the past I only had to argue with other shareholders, who at times were just misinformed or a little too pie in the sky. But you three are a complete waste of energy.
“Arguing with an idiot is like playing chess with a pigeon; no matter how well you play, the bird will just knock over the pieces, crap on the board, and strut around like it won.”
Before your tiny brain explodes, I should let you know JnJ owns Ethicon.
Only I can bring this idiotic debate to an end.
Shoondale you are a moron.
Of course UHP is the sponsor you fool. Who else would sponsor it you imbecile.
Here’s a JnJ Surgicel clinical study for reference. You are out of your league here, you absolute loser:
ClinicalTrials.gov ID NCT03762200
Sponsor Ethicon, Inc.
Information provided by Ethicon, Inc. (Responsible Party)
Last Update Posted 2021-07-26
SPONSOR
Ethicon, Inc.
COLLABORATORS
No information provided
INVESTIGATORS
No information provided
Not confrontational at all.
You asked a question and I answered it.
BTW here’s the response you gave to a well thought out intelligent post by me:
“No Shit”
So quit your whining. You’re lucky I responded to your uneducated drivel in any way.
I know exactly how long you Claim to have been a shareholder and CLAIM to have worked in the industry. I just don’t believe you.
Patent to 2029. Which you should know if you’ve really owned Ueec as long as you claim. The rest of your post is too foolish to respond to.
July 15th has passed. Likewise July 10 - 20th. So however one chooses to interpret mid month, the test results must be in.
I suppose Thom’s last PR didn’t commit to a actual timeline for his follow up to those results.
However he wants to play this, to me it is further evidence of his blatant disregard for shareholders.
Trust’s words stand the test of time:
“I don't believe anything they say Dark. Learned my lesson a long time ago. If you took the amount of crap they told people that didn't come true, you would have a dinosaur pile of crap about 10 feet wide and 7 feet high. You would think the fools running this thing would be put under a deadline. Get it done by this time or you are history. That would motivate them.”
Trust“
Your last 7 posts have been directed at the “paid bashers.”
You are quite the puzzling person Rodster.
In Fact, a few posts back you lectured to Not reply to these bashers. Then your next post was a reply to Scumbag.
Check out this post from the Scumbag whining away to admin about how unfair Ihub is.
Though he tries to act like nothing bothers him, just read to see the depth of his suffering.
Some of you are even quoted as he begs to be treated fairly.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172399747
So if you’ve ever had your post removed for replying to him you know why.
He’s just a scared little boy with no one to play with at recess.
If he’s suffering he wants everyone else to as well.
That is really sad, and again, help is available. Please seek it out Scumbag.
Good luck with your future self.
That confirms it.
You’re more disgusting than I thought.
Only you could find victory in getting banned for posting videos of wife abuse.
If it took getting my posts restricted to make that happen, I’d do it 100% of the time.
Again, you are a horrible person, but you can change and ask for help. I truly hope you do. That would be a best case scenario.
Good luck with your future self.
Wake up bro. If Thom stays true to his word, there should be a PR by tomorrow evening.
Good or bad it will set this board ablaze.
Only a fool would wish for anything but the best case scenario in all situations.
Though I am incredibly realistic and accurate in my posts, when it comes to a pr that could set the course towards a successful PMA I will hope, wish and pray for a positive outcome.
Normally I don’t respond to you or anyone else who finds abusive behaviour funny, but since I am no longer restricted to one post a day, I figured I’d burn one on you.
Wishing everyone the best of luck as July 20th quickly approaches.
Hopefully, after 2 years of this Thom led dog and pony show, good news is on the way. We deserve it.
I hear you Band Aid. Unfortunately, UHP’s timelines have never reflected shareholder wishes.
And UHP’s amateur submission technique is yet to live up to FDA standards.
The positive side is that if they can get the results confirmed mid month we should be away to the races.
However, until proven otherwise, Trusts words (though extremely negative and alarmist) still ring true:
“ I don't believe anything they say Dark. Learned my lesson a long time ago. If you took the amount of crap they told people that didn't come true, you would have a dinosaur pile of crap about 10 feet wide and 7 feet high. You would think the fools running this thing would be put under a deadline. Get it done by this time or you are history. That would motivate them.”
Trust“
Your confidence, though positive is also ill informed.
The presser states that the batch test results should be available mid month.
Those results (only if positive— of course pr didn’t mention this angle) will then be incorporated into the PMA. Submission date of PMA was not stated. Hence, PMA submission date shall remain unknown until we are advised. ASAP is not a date either.
They did however, commit to informing shareholders of the test results once received mid month.
“ the company now expects the full results may not be available until mid-July rather than the end of June as previously stated. UHP will issue a statement upon completion of this process. The results will be incorporated into the PMA application, which is otherwise complete, and the full application will be submitted to the FDA. The company has notified the FDA of its intention to file this revised PMA submission as soon as possible.”
Many will attempt to bend the PR to their own agenda, but my breakdown is both factual and accurate.
Rodster, making Roddy the Rodman comments. Keep ‘em coming bro.
Yes Rod almost a full year. I’m not sure if Thom knew the meaning of the word EXPEDITIOUSLY when stating this on July 15 2022.
We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
ex·pe·di·tious·ly
adverb
with speed and efficiency.
I think you had read the pr because on July 18 22 you followed with:
Thank you! We are fortunate to be on the verge of succe$$.
$5-$10+
Personally, I was hoping the correct paperwork could be submitted within 3 months.
But I also cautioned to do it right.
I never imagined they were so far off track.
“ I don't believe anything they say Dark. Learned my lesson a long time ago. If you took the amount of crap they told people that didn't come true, you would have a dinosaur pile of crap about 10 feet wide and 7 feet high. You would think the fools running this thing would be put under a deadline. Get it done by this time or you are history. That would motivate them.”
Trust
The only line that matters in the NEXT PR that will imply Hemostyp manufacturing is moving in a positive direction towards PMA:
‘…The testing of additional batch lots of Hemostyp returned favorable results indicating that Hemostyp is manufactured, packaged and shipped with specs identical to those in the human trials. These results have been incorporated into the PMA application, which is now complete, and the full application will be submitted to the FDA.
We have alerted the FDA of our intentions and expect to have confirmation within 30 days that the PMA application has been accepted and put forward for substantive review…’
If this is not the case, hopefully they are clear and to the point with what the future holds for Hemostyp and the next steps in the process.
Obviously, there is much more involved then just receiving the testing.
A clear and non-misleading PR would have stated.
…. ‘If the testing returns favorable results indicating that Hemostyp is now manufactured, packaged and shipped with specs identical to those in the human trials, “ The results will be incorporated into the PMA application, which is otherwise complete, and the full application will be submitted to the FDA.”
Good Morning Rod. Thanks for cleaning up the White Lion comments. As you know from studying the agreement the lowest WL will be issued share purchase notice is 0.2325. So you’re right, the current pps does offer the opportunity to raise funds at this time. However, the shares will be brokered, And quite likely be a large purchase of 1 million shares plus.
Hopefully, UHP has issued the PN and WL agrees to make the purchase. It would be a great injection of $$ to see this through to the finish.
If I’m correct about last week’s trading then a day like Friday saw over 100 trades go through of 4000+ shares on average.
That’s a positive sign that new investors are getting on board and/or current longs are building their positions. While some have seen it as an opportunity to jump ship and move on.
Always remember every non fiction book you’ve ever read, movie you’ve ever watched, conversation you’ve ever had is based on learnings from the past. You can’t run today if you didn’t know how to walk yesterday.
A resume is built on past experience and learning, not dreams of the future. I see you have Linkedin so just check anyones page (including Thom’s) for how they present their PAST credentials.
Since, even I can’t see the future I must continue to judge Thom on his UHP performance. To date, I and many others are not impressed.
However, if he continues to move this forward efficiently I will gladly stop saying- where was all this action two years ago- and start believing he NOW knows what needs to be done.
Of course, this can only happen if he has not IGNORED the past, but instead, LEARNED from it.
———-
As a simple poster and non insider, I don’t have real time trading data or access to PNs. So if someone wants to check my numbers or comments I’d appreciate it.
That’s so true Rod. Let’s take it a step further and Imagine if Thom and team knew how to amend a PMA within the first 6 months of his tenure.
$1.10 x 59% increase would have had us at $1.75.
Not to mention this entire process would have been completed by Summer 2022 and we’d all be counting our money.
Especially, at a very conservative $8 per share (rumored acceptable buyout)
Hopefully the NEXT PR brings more encouraging news and we push this into the 0.40s +.
(Or what would have been $2s if Team Thom was more proactive out of the gates.)
But hey, live and learn Bro, live and learn.
I agree Trust. Here’s another example of a simple PR acting as a distraction to the FACT that FDA and the European Union both recognized Hemostyp as a safe and stable device for 8 years.
This same recognized product was used in Human trials and the results are a resounding success.
Yet in Thom’s 30 months he has been unable to convince European’s or the FDA that NEWLY manufactured and packaged USA products are not only safe, but are also identical to those used in human trials.
Like you, I refuse to pat him on his back for something that should have been completed minimum 18 months ago.
For once I’m going to keep quiet and let Merriam-Webster provide my summary of this PR:
United Health Products Reiterates Guidance on FDA PMA Application Process
REITERATES
verb
: to state or do over again or repeatedly sometimes with wearying effect.
WEARYING
Adjective
exhausted in strength, endurance, vigor, or freshness
: having one's patience, tolerance, or pleasure exhausted
“Testing of these additional batches has produced satisfactory results”
SATISFACTORY
adjective
fulfilling expectations or needs; acceptable, though NOT outstanding or perfect.
PERFECT
satisfying all requirements
corresponding to an ideal standard or abstract concept
a perfect gentleman
faithfully reproducing the original
specifically
legally valid
WAVY
adjective
having a form or edge that smoothly curves in and out.
This is true, and they are the masters of giving just enough information, stated in a way to cover their backs and leave another little ray of hope to keep investors, and potential investors, eagerly anticipating the NEXT big PR.
For years the NEXT PR will be the big one.
Well, the formula is wearing thin and it has been reflected in the steady decline in pps since Thom’s arrival.
Will the NEXT PR be the big one? Or will we get just enough information to wait for the The one to follow.
June 2020 most thought COVID was the sole reason that Hemostyp wasn’t already approved. Eagerly awaiting next PR.
June 2021 most (that misread PRs) eagerly awaiting imminent approval in NEXT PR.
June 2022 all eagerly waiting for the July 2022 FDA meeting and the PR to follow.
June 2023 all eagerly await the latest product test results and the PR to follow.
So in 4 Junes(and much further back, but I made my point) Hemostyp has gone from Imminent approval, to FDA reset, and incredibly, to testing product for specs validity.
Like the $PPS this PMA is going in the wrong direction.
It reminds me of that movie:
The Curious Case of Benjamin Button.
However, if the goal was 30 months of buying opportunities then well done!
Not a “moot point” at all. In fact it’s just the opposite.
UHPs recent actions under the guidance of PMA consultants prove that.
14 months ago I correctly stated:
“There is nothing the FDA can do until UHP can prove capable of producing hemostyp gauze in the new facility exactly as they used in the human trials.
As a result, until they get a line running at Strouse (or wherever they intend to make it now) the FDA can not complete the approval.”
11 months ago UHP finally admitted (or finally just learned) this was in FACT the case.
6 months ago UHP enthusiastically stated:
“The measured physical and chemical characteristics of the new product were shown to be effectively identical to those of the HemoStyp gauze product utilized in the company’s human trial, a key step toward demonstrating a supply of equivalent product for planned commercial production. The company will now incorporate these laboratory results and other data into its PMA application for submission as soon as possible”
But 4 months ago under consultation realized to go forward with the PMA —multiple batches must be run and packaged to prove the whole process could result in Identical product to the Human Trials. And the process must be repeatable.
2Months ago the results were announced as unsatisfactory and new tests batches and packaging were ordered.
Good for UHP to NOT move forward with a PMA submission until all aspects of the product are IDENTICAL, As it would have been rejected.
The Consultant and UHP clearly agree with ME and are NOT willing to submit the results in a “give it a shot” manner going forward.
Hopefully, the current tests are a massive SUCCESS. If not, press pause and return to the drawing board until they get it right.
This is the process. FACT.
This is all very positive. Correct, the safety and superiority was proven in the human trials.
Unfortunately, the human trials were done with Chinese produced Hemostyp, meanwhile the Hemostyp UHP is proposing to the FDA is USA product that in not meeting the very strict criteria of the FDA who want the new product (once packaged and delivered to hospitals and then unpackaged in the operating room) to be identical to the Human Trials product.
Not “Effectively identical” …but . IDENTICAL. No need for adverbs. Identical is identical.
.” Last December, a batch lot of HemoStyp gauze produced under its new manufacturing arrangements was shown to have physical and chemical characteristics that were effectively identical to those of the HemoStyp product utilized in the company’s human trial. Subsequently, the company, in consultation with its regulatory consultant and reflecting feedback from the FDA, has produced additional batch lots of HemoStyp product to demonstrate consistent production, which the company believes is an important criterion for Premarket Approval.“
“ it’s just another fear tactic to spread doubt.” That’s funny. Let’s review my comment on manufacturing…:
“using two facilities seems like a logistical nightmare for a company like UHP and it is my assumption that this is a huge part of why the testing has returned unsatisfactory results which they essentially admitted.
These changes wreak havoc on the original PMA and were the reasons I stated repeatedly that major amendments were needed. “
Now IN UHPs OWN WORDS on how this affected the testing:
“ The testing results showed several anomalies in product pH level and moisture content that the company, in consultation with the laboratory leadership, believes resulted from unintended partial oxidation during the sample cutting and packaging process that was conducted by an external component supplier.”
So that topic is finished.
Next FACT, this is NOT the production technique that will be used post PMA.
And “These changes wreak havoc on the original PMA and were the reasons I stated repeatedly that major amendments were needed.”
My only OPINION (stated as feeling) was “ we will soon learn that UHP has abandoned their quest to produce Hemostyp in the USA. Hence, the emphasis that now the Cutting and packaging is happening in a USA plant, not the manufacturing. ”
Manufacturing topic was Fact based with my OPINION that UHP MAY resort to production outside of USA.
Further, the “hot takes” by definition are to create discussion. Instead posters go in defense mode.
“ Defensive aggression may be growling, snapping or biting when a dog is confronted with what he views as a threat and he is unable to avoid or escape the perceived danger. It is based in a fear which may or may not be reasonable.”
Enjoy the holiday everyone.
Wavy.