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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!
"we doubt that shareholders will hear about it. We expect it will be just like when UEEC applied for PMA approval for Class III in late 2017, there will just not be any updates, like it never happened."
The height of stupidity is most clearly demonstrated by the individual who ridicules something he knows nothing about. Albert Einstein
Hoonigan
Alias Born 06/24/2024
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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."
🏁
Why don't you make it 2035?...More efficient method of stringing the 🍭suckers🍭 along. Get with the program.
I spoke to AI who tells me "An FDA Deficiency Letter is a communication sent by the U.S. Food and Drug Administration (FDA) to an applicant during the scientific review process. When the FDA identifies discrepancies or deficiencies in a product application, they issue this letter to request additional information. It’s not meant to list concerns about the product but rather to inform the applicant of identified deficiencies." I am not concerned that Brian Thom and his team cannot adequately reply but the timeline certainly is aggravating but the efficacy of the product is not concerning to me. Sterilization testing data should provide some information with regard to shelf life IMO! The FDA clock has been paused and is encouraging and also a positive sentiment IMO.
"We are very pleased to have reached this milestone in the PMA process, and to understand the FDAs assessment of our application. We are confident we can address these deficiencies to the FDAs satisfaction. In the coming weeks the company will be engaging with the FDA review team directly to determine the most efficient path to providing our responses."
$5-$10+
Any time we see a PR that states "in the coming weeks . . . " It takes this company 2 - 3 months to actually formulate a plan, respond, get another PR.
With any luck, the FDA 180 clock will start ticking again in September. 2025 Here we come - and that assumes this company does keeping screwing up.
So what I understand is every company when they go for approval always gets a deficiency letter and the clock is always paused. There can be comments or questions. 40 deficiencies is actually not a lot for product on this massive scale from what I’m told .Most important they said they were not starting over the process. They’re just pausing 180 day clock which is routine. Wave might actually agree with me on this. I guess this is what the FDA does.
United Health Products Provides Update on FDA PMA Application Process
MOUNT LAUREL, NJ - (NewMediaWire) - June 24, 2024 - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the companys FDA Premarket Approval (PMA) application process.
Following the companys March 21 submission of its PMA application and as part of its substantive review, on June 18 the Food & Drug Administration issued a customary "Deficiencies Letter" to the company listing certain questions and comments on various elements of the application. The letter contained approximately 40 specific comments and requests for additional information covering the device description, sterility & shelf life, clinical & performance testing, and biocompatibility sections of the PMA application.
Brian Thom, UHPs Chief Executive Officer, comments: "We are very pleased to have reached this milestone in the PMA process, and to understand the FDAs assessment of our application. We are confident we can address these deficiencies to the FDAs satisfaction. In the coming weeks the company will be engaging with the FDA review team directly to determine the most efficient path to providing our responses."
The FDAs 180-day application review period, of which approximately 90 days have elapsed, will be paused while the company develops its responses to the deficiencies that were identified, and will resume once all the responses have been submitted.
There can be no assurance that the companys PMA application will be approved.
About United Health Products -- UHP develops, manufactures and markets HemoStyp(TM), a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.
Oh no. Rodster and DR5. A real dream team. Even combined their grand total of accurate posts or predictions remains ZERO.
One is down over $400,000 on this investment but refuses to challenge the status quo.
And the other guy, well I think we all know his track record. BEIL, QTMM.
Now that’s funny.
Good luck guys. You’re going to need it.
Cheers Roddy!
🤣Thats a good one!
$5-$!0+
It’s nice living “rent free” in your miserable mind…..lol.
Hey Board, did someone appoint DR5 the judge and jury on who gets “attacked.”
I personally have never strung together a string of posts to Trust or anyone else, like the ones DR5 did (see below) to another poster.
His “special relationship” with trust. And their plans to slip away to Italy together have left him blind to the tone his other messages on here.
DR5 posts below:
“Hey MORON, we have a full clinical submission on 3/20/24. You post nothing but BullShit!
You ass! That statement is what EVERY company has to put in their pressers when going for an approval. Just standard legal jargon! God you’re an idiot!
You are a liar and a FRAUD!
OLD NEWS, DUMMY! That’s been settled back in ‘22. Clean slate now!!!! What an absolute idiot you are!
You’re a despicable piece of garbage!”
——
I have debated with the same poster and never had to resort to these “attack” statements.
I wasn’t referencing you wave.. just speaking in general.. and I do mean it when I say we’ll accomplish more together as opposed to enemies
Thank you for your response!
Straight from the link Thom’s team shared in the last PR…this reference number is for internal purposes and can’t be tracked online:
Quote:
Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.
Straight from the link Thom’s team shared in the last PR…this reference number is for internal purposes and can’t be tracked online:
Quote:
Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.
💥💥💥
They only thing we will hear from the company is approval and then an offer. That is it. So drop the same old nonsense you have been doing for months now.
I’ll give you the courtesy of explaining your “keyboard warrior” reference.
Remembering, that I was respectfully replying to your question to me on June 12th, when trust blew a gasket.
Good day all! A question for the board...doesn't the FDA assign a PMA number to a product that has passed the initial 45 day review of the application, and then would we not be able to search it in the FDA's PMA database?
You’re right, Jimmy. You need to talk to the other guy. He seems to like attacking posters.
Well we both know this board is about opinion.. it’s also about speculation and in some cases people that know the industry better than others it’s about a more educated guess or possibly even a factual opinion.. HOWEVER LOL we will have the keyboard warriors that get out of hand and take it to the next level… personally I think if we’re all longs and waiting on fda approval we should all be on the same team and we should be eagerly waiting on positive news from the company.. and the rest everyone needs to take it down a few notches .. again just my humble opinion
“Attack on trust. “. Hahahaha.
I quoted his “attack” on another poster and you run to his defense.
You’re such a follower. You should have backed up JHog at the time, or any others that he has “attacked.”
You’re such a coward. It’s easy to stand beside the loudmouth in the class.
Anything to not get bullied yourself.
I remover a post a few years ago when you thought trust was mad at you and you almost had a nervous breakdown.
Take a look at waves attack on trust. You all see what I mean? This guy is a mean-spirited narcissist with arrogance and hubris as his side-bar.
I offered the guy an olive branch but he just is too full of himself to take it. Really a sad man….
Here’s the uneducated response of a madman, to another’s opinion.
Same old garbage spewing from him for 5 plus years. 5 years of this loud mouth saying the same things every time someone offers an opposing opinion.
trusttheman
Re: Chrism0000 post# 2517
Tuesday, 05/21/2019 3:15:03 PM
You're clueless JHogg. What is out there is a pile of garbage. You clearly know nothing about the industry or the products in this field. Please sell so I can laugh at you. Now go away little boy. If you believe any of the garbage you are talking, you would have sold a long time ago. You're just another pathetic troll, looking for some insight. Like I said, sell all your shares so the board can have a laugh at you. Oh that's right. You won't because you're another imbecile who wants to try and buy more at a lower price
JHOGG
Re: Justdave1 post# 2512
Tuesday, 05/21/2019 11:21:13 AM
It will not corner the market. What MDs are using now works! Hospital contracts, pricing, MD relationships, changing habits and many other factors will be in play for this product to get stocked and used. This product will not grow the market. Therefore, either a company will acquire Hemostyp to keep current market share or a competitor will acquire to enter the market. The later must have significant roots in the hospital system to make an impact. $1B buy out would be a big win! $1.4 Max!!!
I rest MY case…
“holiday scam story, it shuts you right up”
I am proud of that post. I have never and will never “shut up” regarding an opinion based post. I have reposted and quoted from it many times.
You need some therapy to help get over it though.
You have no case fool. Every time I bring up your holiday scam story it shuts you right up because you know you have no credibility any longer. I don’t think any longs have listened to you in well over a year. Not to mention, I would assume that most of the longs believe you don’t own any shares as do I. You might want to try swimming in Florida waters this time of year. I hear it’s safe.
You know …. all you have to do is act respectfully to people who post here. If you change your behavior, surely people will reciprocate.
That post says it all.
I rest my case.
I really don’t care what you are saying….that post was a week ago. Again, I just agreed with it. I didn’t directly jump on you. Don’t try and worm out of your behavior. You know what you’re doing. Take responsibility for your actions and leave everyone alone.
Wave has been wrong forever now and he keeps on thinking we are going to just dismiss his holiday lowlife stunt. The simple fact is he knows absolutely nothing just like the rest of us. The only ones who know when this will be finished is the company, the FDA and God. Once in a great while, I’ll waste time on wavy, but it always ends up being stupid. He doesn’t own any shares.
Wrong again DR5. Here’s his reply following my June 12 opinion of the PMA:
trusttheman
Re: None
Monday, 06/17/2024 10:33:26 AM
You're embarrassing yourself again Wave. Your last post is why I'm extremely confident you aren't a shareholder. You would have to be unbelievably dense or just corrupt to compare a press release in 2021 to now in 2024. You of all people stated how much the company had to do back then to get to this point. So now, when they have the application completed and are at the door you think the company should update shareholders with FDA news? You are out of your mind. The company should not and will not disclose anything at this point. They would be insane to do so. If you were playing close attention to things which you obviously aren't, you would know the following. Brian and the team have been burned multiple times by vendors and others who told them something would happen at a certain time and then it didn't. So, Brian and the team looked bad updating shareholders with things that didn't happen. They are tired of that happening to them and rightly so. They only thing we will hear from the company is approval and then an offer. That is it. So drop the same old nonsense you have been doing for months now. Trying to create panic just like with your holiday b.s. story that nobody has forgotten about.
CASE IN POINT!
This was trust’s post. I agreed with it. You were not mentioned at all in this post but you “just couldn’t help yourself” and you attacked me. You see what I’m talking about. Your denial is meaningless. It’s also not just a river in Egypt…..it’s your mantra. Grow up!
If you don’t like the stock or don’t believe in the stock then get the hell out of here. If you’re that ignorant and delusional that you think going through clinical trials like they did and annihilating the only product that’s any competition somehow isn’t true, get out of here. If you’re that clueless that you think a company going through clinical trials and now completing the application for submittal to the FDA somehow doesn’t mean anything then get the hell out of here. Why would you waste your time day after day on a board if you don’t believe in something? Oh, that’s right, because this site is basically paying people to put stocks down and try to keep them down so people shorting it can make money. For the most part, they’re effective at it. But when this gets approved, they have absolutely no chance of holding this thing down.
The corrupt market makers know what is going to happen with the stock. Anybody who’s bought shares of the stock can see the corruption going on with the market makers and how they try to keep this down for bigger clients. Yesterday there were two huge sells. It wasn’t a long selling. It was corrupt people trying to cause panic to drop the stock so that they could buy more cheap. It’s been going on forever. Frustrated we are as longs but we’re not buying into this crap because we know what this product is and what eventually will happen.
You’re. Not your.
Please reference a false post. If I am the “king” there must be many.
Your wrong and the king of false posts!
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Not true at all dr5. As in this post I’ve replied to from June 12th.
I gave a perfectly respectful opinion on where this PMA stands. Only to have trust chime in with all kinds of insults and accusations.
Sometimes I have to be more aggressive if people go too far with false meaningless unrelated statements and claim they “researched” the info so it may be taken as true.
Am I hard on you guys after you make unrealistic predictions and claim to have insight? Yes, but only if I know you are 100 percent wrong.
I’ve never told other posters to “sell all their shares” or “get the hell out of here.”
I’ve never called others “shorts” (other than Sporty,) “paid bashers.” or “disgruntled former employee.”
I don’t have to swear at posters.
Boards are for debating. I do it very well. At times I do have to absolutely destroy posters to keep them in line. Otherwise, I’m pretty quiet on here.
So yes, go back and read my posts. It will do you a great service.
Hey Jimmy, I think everyone here who has witnessed waves comments knows that he not only lashes out at myself and trust, he lashes out at anyone with an opinion on this stock. Just go back and look at his posts. I think that guy needs to look in the mirror and realize he’s the problem here.
Good call Jimmy. Unfortunately, if anyone posts so much as an opinion that isn’t agreeable to Trust and his minion, things spiral out of control.
Fellas… as much as it’s interesting to see the back and forth.. I think we just need to remain focused on the goal here and that’s the approval and accomplishing the goal., good luck all
Hilarious, after I quote you stating “I told you so,” you go on to say I’m always saying I’m right.
Of course you ended up being wrong, but the point remains the same.
Imagine how you’ll react if you are ever right about something.
I guess we may never find out.
I still have you on “ignore”amous. There’s still ten days in the month and I was speaking “generalities” you narcissistic, nut case with delusions of…”I know everything cause, I’m so right ….all the time! Well, you are not. I said the end of June to hear something and I’m thinking if it goes for two or three weeks more…so be it. You’re talking end of September. I believe approval will happen as soon as July. We may have a small deficiency or two to address that shouldn’t take much time. Boy, you are such an ass!
DR5
Re: None
Thursday, 09/10/2020 12:29:09 PM
For those that doubted my saying that approval is in the near term......I told you so!
Ouch.
I thought you had me on Ignore.
Plus, I said you shouldn’t read the post. Now go reinsert your head.
Now that I know you two don’t have me on Ignore, I’ll be sure to alert you when the “WITHIN 180 day” time line starts.
Maybe if you “researched” the correct PMA process you’d be able to speak intelligently.
Even your juvenile name calling reeks of uneducated simplicity.
So lame. So weak. So sad.
Mr. Wavydouche……you will be wrong in an “Epic Fail”…no, we will not have to wait 180 days. Not by a long shot! Then you will wallow in your own excrement.
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