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I know the FDA guidelines, and I know how to read a PR. Based on both the FDA PMA timelines and statements made by UHP, it is a certainty that the FDA has communicated with UHP since the PMA was submitted.
Good Luck to all. There’s a long weekend coming, but I’ll save my BBQ hot takes this year. So everyone just relax.
They’ve already made the 45 day decision. We just don’t know what it is.
Plus Zorax is just some guy that slithered in here and took a moderator spot hoping to trash the board. He can’t do better.
I see that I have reduced you to idle ramblings.
Just spewing out drivel.
I’ll leave you alone for a while.
It took you 5 days to come up with that work of fiction?
“Working forensics for law enforcement”
That’s the best line I’ve heard on here in ages.
Do you want to try this one again:
“I've recovered in value of jewelry and objects and returned it all to the owners than you've made in penny stock in the last 30 years.“
Not bad Shoondale. I’ll give you credit for trying. You put in some work and searched Google for funny Fishing Gifs.
I don’t know this young man, but based on his tan lines he’s likely a hard worker Mon to Fri and just out enjoying some weekend R&R. Good for him.
You should have added “beach” to your search though. That would have been much more relevant to our banter.
But again, good effort, I’ll give you a B+
BTW…what on earth does this attempt at detective work mean:
“This hints at someplace tropical or at least sub-tropical which are generally the most expensive places to live especially near the water.”
You generalized an entire geographical temperature zone to suit some weird agenda that Zorax is wealthy.
BTW. It’s 82 degrees in Cleveland today. Edgewater Beach is rocking.
Hey, there’s a detectorist. Maybe it’s Zorax.
Shoon, do you know what color speedo he’s wearing today.
You two make this too easy.
One thing you do know about Zorax, is that he’s the moderator of this board.
Meaning he can delete offensive messages.
However, he chose to leave a message directed at you last weekend for all to see.
He didn’t delete it and he definitely didn’t try to defend you.
It would still be posted if I didn’t report it.
I chose to report it and also called out the poster for going too far.
So I find it odd that you would post a long post about metal detecting, when he couldn’t care a less that someone wished the worst possible fate on you.
Truth is, I don’t know you from a “hole in the wall,” but I wouldn’t let that stand.
Remember that Shoondale, not one other poster cared a bit. Including your Zorax.
Bottom line, I shut him down with ease as usual, your ramble doesn’t help his cause.
Wakey wakey Zorax. Some poor little kid lost his ice cream money at the beach yesterday. This is your big day to make some $$ with your “enjoyable hobby.”
Don’t let the bottle caps get you down either.
Your treasure may be in the next stoop and scoop.
That sounds about right. Scavenging around the beaches desperate to make a few dollars off other people’s misfortune.
The ladies must be very impressed.
Thank you for finally telling the truth.
GetRch, interesting that you’re lecturing on patience now. The posts relating to future PRs by Pragmatic and I are clear statements of how the PMA timeline works. And could (should in my opinion) result in a PR.
BTW, where was your patience in March when you wrote:
“8 weeks to review sterilization data and submit is plenty long enough to have given a further update. This tells me that either they submitted and have big news coming, but are fearful of leaks so don't want another PR, or they are clueless on what to do next and are fumbling around looking for a Doug-like expert to bail them out.
Enough is enough Brian - Finish the Deal!”
OR Dec 2023:
“11 weeks is MORE THAN ENOUGH TIME to complete those tests. From the companies I've run, and my experience, If I was Thom, I would be sleeping at the test facility, right next to the testing team and the owners working daily to get this done well, ASAP.
I get "wait and see for shareholders." The wait and see by Thom while the test facility F#*^S around is INEXCUSABLE. Take some ownership and walk the test facility across the finish line.”
It’s amazing how bad you are at this, considering you post so often.
You are a living contrast to the book “Outliers.”
Malcolm will have to do a complete rewrite of his premise.
That’s pretty sad Zorax. Did you spend the last 3 weeks reviewing my posts (as I suggested) looking for any evidence of a “GRAFT?”
I know that’s an impossible task.
I wanted you to spend the time learning about hemostyp and the PMA process. Not looking for “grafts.”
When I reply to Shoone, and provide clarity that may support his view, then so be it.
I’m not on anyone’s side here. I just provide realistic, fact based information.
I believe I also had to help him when he made a “graft” about Texas and Nevada.
Your tax comment is full of “grafts” as well.
It actually exposes just how desperate you are.
You completely misinterpreted my statement with your “tax friendly “ gibberish.
I didn’t say Nevada was a Tax Free state. I clearly said Zero Taxable Gains.
I also said “hope to go tax free”. Hope. No guarantees.
BTW were you drunk when you wrote this:
“Thanks for that. I'm disappointed that your superior intellect didn't catch your graft. Or as an employee of uhp, just setting up the groundwork for a furture p&d?”
Pragmatic, another accurate post re the current state of the PMA and where it stands with the FDA. Thank You, Hopefully UHP updates Shareholders in a timely manner.
If/when they announce if the FDA has agreed to File the application, Hemostyp will then (and only then) move on to the full review stage.
Typically UHP is quick with positive news, and vague with negative news. We’ll see what happens this time around.
Here’s a quote from the last time Hemostyp got to this stage successfully.
May 5,2021,— yes 3 years ago.
“following the resubmission of its application for Pre-market Approval for HemoStyp gauze on April 6th, the FDA has now accepted for review and commenced its Substantive Review of the application.”
Hopefully there are no resubmissions required this time around. As in that case, the original was submitted Oct 2020.
Oh man, this guy is seriously traumatized over a “summer” post. Call a dr5 and get him the help he needs.
Trusts bombastic(and wrong)political predictions:
trusttheman
Re: DR5 post# 4494
Thursday, 02/20/2020 11:02:34 AM
Trump won't break a sweat getting re-elected. Not only that but you won't see another democrat win the presidency for the next 20 to 40 years. That is the kind of damage those dopes have done with their sulking attacks on this president. The democrats are finished as a party.
Wrong wrong wrong again
Regarding your opinion of all the other longs on this board, my inbox would prove you wrong. You travel in a tiny circle of people afraid to offer you anything but what you want to hear.
I know for a fact that many longs share my views or at least appreciate them as debatable views.
To the longs that do private message me and ask me to reply directly; my free membership doesn’t allow replies.
Also, don’t be afraid to post your opinion on the open forum. I’ll protect you from any backlash from trust and his little group of mean girls.
But you do read my posts.
My posts are accurate and fact based. Yours are loud and based on your broad reaching uneducated views.
Why are you so mad if anyone has a different opinion than yours.
I post your old posts as an example of your bullying tendencies.
I will continue to do so as long as your only debate technique is to tell people they are shorts, disgruntled employees, trolls etc.
Did you ever think some people just have a different opinion than you.
Can someone get Trust some therapy for the depth my “summer holiday” post has affected his life.
As all can see by reading these posts, I am clearly not the miserable one.
Every bully needs a good smack once in a while.
Consider yourself smacked.
Trusts recent stocks and posts. It’s toilet bowl time. It’s laughable that you still have the nerve to call out anybody.
TPTW- fail
Trusts quote….
“So what does all this mean? This garbage share price might actually go up or will it stay at this embarrassing level forever? I've held onto what I have. There is no point selling it. It's worth nothing…”
COWI-fail
Trusts quote….
“It might help if the buffoons running this company put out press releases more often than 10 to 15 weeks. Just saying. Holding but when you don't release news often, people tend not to think the company isn't going anywhere.”
GTII-fail
“Gtii back to sucking. Lol. Why am I not surprised. I honestly don’t know how people make more money keeping a stock down on the OTC rather than if they just ran it up”
GVSI- fail
“There was no news. A real company actually does a press release so people can see it. Companies run by a lawyer not a real CEO use social media to release some nonsense news”
BIEL- fail
“It's not going anywhere when you do 2 or 3 press releases a year. Sorry, but the people running this company have no clue how to raise this stock to .05 and higher. It's obvious. Yet, I still hold hoping somebody running things will get a brain one of these days.”
“Back to a pile of garbage. Why O why do I ever believe in this stock.”
QTMM -fail
“Let's hope this stock doesn't suck in 2020. So far they haven't realeased much to the shareholders. No issue with that as long as they aren't screwing things up.”
Wrong again Trust (or do I have to start going to your level ..,trustthedouche.)
But that would be too easy and really lame.
So just a simple - wrong again Trust.
I have only mentioned the 180 days once, and that was a direct quote from the FDA.
For some reason the phase “..up to 180 days” really upsets you.
Are you so incredibly negative that you can’t see the “up to” part.
Quit seeing the glass as half empty. Maybe the “up to” part comes true and approval (if granted) comes in 154 days, or even 142 days would be nice.
So when your night shift is over, get a good sleep and start the day with a smile.
These sound (or is it read) like the words of a short trying to get everyone to sell.
trusttheman
Re: Chrism0000 post# 11667
Tuesday, 06/27/2023 6:32:10 PM
Are all the longs still alive? Waiting for the clown college at Ueec to finish something. Lol.
So you’re saying there’s a chance.
This has been a busy day…
First there are no employees. Then I find out I was an employee and was fired. I hope I got a good severance package.
But wait, another insinuated that I also associate with Thom through my company Waveny Partners.
Last week I was a short.
My goodness this is a lot to keep track of.
How much were they paying me? Was I possibly getting $15,000 a month like Thom. Paid via shares if needed?
Wait, if Thom is my associate through Waveny, am I not entitled to some of the 15,000 a month he currently makes.
Hey now, hold on a second, If I am a former employee, clearly I would have been the smartest employee and thereby be the CEO.
And the CEO was fired (stepped down.) Hmmmm
Again, it is in your best interest to read all of my posts. Yes, all of them.
They have had one PMA that made it to the in depth review stage.
It was deemed Not Approvable.
Conditions were not met in a timely manner.
March 21 new application submitted.
We will now wait for UHP to let us know if/when it is filed.
It will then move to the substantive review.
I suggest you go back and read every single one of my posts.
Zorax too.
You’re never too old to learn from the master.
They have outlined the reasons it was Not Approvable in PRs. At least to the extent required.
Unfortunately, they weren’t able to correct the issues in a timely manner and therefore put in the position of a new submission.
I have noted many times that this company writes deliberately vague PRs.
I am the only one that seems to be able to read them with an open mind and interpret them correctly.
Whoa, total burn!
Have you ever heard a person that can “speak to an issue.”
One doesn’t say/type “I can text/write to that issue.”
Are you filling in for Trusttheman with grade school logic?
Their last PMA was deemed Not Approvable. Hence, the new PMA submission with updated product testing.
I will answer you this time, as I know I am the only one qualified to speak intelligently on the topic:
Zero Capital Gains in Nevada.
Their original office was in Nevada.
Former CEO and majority shareholder continues to live in Nevada. Hence, they may as well keep a PO Box and hope to go tax free after the big acquisition.
BTW I exposed the Uhaul location years ago.
You thought you were on to something big there, but …..different towns…different states.
Nothing gets past me.
You’re welcome Rodster.
Trust, I’ve noticed that you’re getting in the habit of posting right after me and pretending you didn’t see my post.
Hilarious, your childish behaviour is beyond compare.
Anyway, when you’re private messaging with dr5 in 3 minutes, tell him I’m waiting for a response.
dr5, when you come out of hiding I would like to know your motivation for posting 510k timelines and not the PMA.
UHP press release clearly states this Is a full PMA and went so far as to provide the FDA link to the PMA process. Literally inviting readers to follow along with the timeline. There is no confusion here at all. Yet, you did your “research” on the 510k.
How desperate are you? The sad thing is no one else here would notice.
But you must have realized I would expose you.
Here’s the Company quote:
The company confirms that it has submitted via the FDA eSTAR portal its Premarket Approval (PMA) application for its absorbable hemostatic gauze, which will now be reviewed by the FDA and Health Canada. Information on the FDA review process for PMA applications can be found on the FDA website at:
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process.
…..please don’t try to explain that the two are interchangeable and Hemostyp was fast tracked into the 510k process .
Chris, a belated Happy Birthday.
I wasn’t posting in March so I missed it.
I’m sure it’s been a long two years since dr5 promised you a happy birthday gift of approval. Hopefully, you didn’t believe his empty promise:
DR5
Re: Chrism0000 post# 8244
Sunday, 01/09/2022 1:57:57 PM
Your birthday present will come well before that.
And now here we are in 2024 and he’s still trying to make “educated guesses”
As always you are wrong Trust.
Sporty was replying to your reply to Zorax. If I thought he was replying about my posts I would certainly have replied to him.
Don’t worry you’ll be right eventually.
Ah the good old days in 2019,
trusttheman
Re: JHOGG post# 2083
Thursday, 02/07/2019 8:21:30 PM
Just shut your holes already. Just wait and relax. Jesus. You still don't know what you own. Wait and get rich. Insane product. Brilliant CEO. Let the moron doubters lose millions.
Here’s Trust’s educated analysis of how long human trials would take.
I was just a quiet and patient observer at the time. But the lemmings on here just kept letting him bully them.
Of course his two week timeline was absolute insanity and it took 2 years to submit the outcomes. DR5 thought 1-2 months max:
trusttheman
Re: DR5 post# 1491
Monday, 08/13/2018 10:25:40 AM
I'm thinking a week or two. Not a month or two. Way, way, too long. There is no reason for it to go that long.
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,