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Thanks for the clarification. My apologies. I wasn't trying to misinform. I just wanted to help those poster that ask every other day if this is the day :D Just simply showing that 90 days is a realistic best case scenario. To your point, much longer typically.
Given UEEC track record, I'm leaning on the longer end of the stick.
To your point - this may be closer to a Halloween treat than an independence day victory.
Anything sooner and we will all be very pleasantly surprised.
So another SUMMER!!!!! of being POOR!!!!!!!!!!!!!!!!!!!!!!!!!!! :(((((((((((((((((
Funny always easy to pick out the bashers who work in pairs but yet both are pennyless!
zorax and schoon were made for eaxh other. Get a real job boys you suck a this one!
$5-$10++
"Nobody here is selling"
FDA won't even look at the PMA if it's not proper. And that's where uhp keeps itself in the story. If they actually submitted a correct PMA, the FDA would process as normal no matter how many days/months it takes. The thing is UHP doesn't want the FDA to discover the fraud. So it's the 'first step' loop and your 'helpful' pumping.
All the FDA compliance nonsense looks convincing to the non fundamental trading public which is the easiest marks on the planet to sell your scam shares to.
This isn't rocket science, and neither is filling out FDA applications. In UHP it's important that that shiny new rocket is in full view of the otcm but never gets off the launch pad.
If uhp did that, they'd have to actually come up with a product. Which everyone and their sister knows they do not have. Nor do they have any interests in doing.
Nobody here is selling Zordouche. Fools like you have been trying to get people to sell this stock for the past three years and it hasn’t worked and it never will work. The only people keeping the stock down are the corrupt market makers but eventually that won’t work when they get approval. It’s over dude you lost go find another board. You’re wasting your time here.
Being wrong by mistake and wrong with intent are two different things. On a chat board it's wrong with intent. Called lying, like wave and roddy. Knowingly, for whatever their reasons.
A scam on the otcm needs at least two fundamental things. A sham product and story to sell stock and time to sell the stock. A story of governmental involvement always is one of the best schemes. In uhp, it's perpetual purposely incorrect filings and promised testing gives the story and time to unload. Blaming the system is just icing on the cake.
UHP is content in it's stories and time. Simple as that.
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,
"You have simply pasted what a simpleton wants to see"
"Imagine a major disaster when bleeding re-occurs after the surgeon has already closed the outmost patient skin layer! "
https://seekingalpha.com/article/4300303-united-health-products-press-releases-cannot-be-taken-face-value
What a foolish scam this is fishing for suckers to lay their money down. What a joke to think the cheapest Chinese bandage money can buy will ever be used as a surgical bandage. Who could be possibly be insipid enough to believe this u-haul dealer in the desert headquartered company is producing a surgical bandage.
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.
Was told you responded Wave. Not reading it because you aren't man enough to admit you were wrong. Also, learn to read. I said you were wrong about the PMA. You said you expected them to complete the application by last October. Then when it didn't happen, you vanished like a coward because it's not in your nature to admit you are wrong. Thus, when I stopped listening to you. Everybody here has been wrong. Difference is, you are the only one who can't admit it. Read DR5's post. Now that is fact. Go back into hiding.
The data I just posted is from the FDA.GOV website. You are a jerk as usual. Go back to bed and come back in 6 months when all will be approved and deals in the making. From here on out, you’re ignored and blocked.
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.
Sleezy boiler room fraud about cheap Chinese gauze that is totally non-functional even over the counter. This pathological, sociopathic bullshit you spew does not even belong on ihub.
https://www.sec.gov/files/litigation/complaints/2022/comp25413.pdf
This con artist outfit is such a sham, headquarters, as listed on their website, is a u-haul dealer in the desert.
The CEO of this stock scam is actually a stock broker
https://brokercheck.finra.org/individual/summary/4231884
Evidently he does not even want his clients to know he manipulates this stock scam Ponzi scheme:
https://www.butlercap.com/our-team-2
Right you are trust. A quick search of 510k medical device approval time gave this explanation:
“How long does it take for the FDA to approve a medical device?
According to the FDA, the typical timeframe for FDA 510(k) approval is 90 days. Applicants can expect an acceptance review decision within 15 days and a substantive review decision in about 60 days. A final decision usually comes within 90 days. If there are review issues, the applicant is notified within 100 days.Oct 19, 2022”
Nonsense Wave. You were wrong many, many, times about when they were going to complete the PMA. Thus, why you vanished. The FDA has already reviewed and signed off on 90% of what was needed for approval. It also not a brand new application. Total lie. It's a complete application. Also, the FDA created the eStar application because they told people that they don't take a long time to approve things. The issue was that people didn't submit the application correctly and had to resubmit over and over again. One of the things this company was doing. Plus, you might want to actually do some research on Surgicrap. You would find out that product was never approved by the FDA. It was grandfathered in. It has had multiple lawsuits against it for bone and tissue damage. In other words, the FDA wants to rid itself of that pile of garbage as soon as possible. I expected better from you than coming on with a total lie about it being a brand new application. Complete nonsense. That would suggest that everything the FDA had signed off on before was now not applicable. Again, nonsense. I stopped listening to you when you were consistently wrong about the company completing the PMA and never could admit it. Back on ignore you go.
"But what is the most alarming to us in the 10/18/19 announcement is that the PR went silent on the very important product safety outcomes. From the UEEC clinical protocol, described on its clinicaltrials.gov page we learned about four secondary study outcomes:
Source: clinicaltrials.gov
While the Primary outcome and the Secondary outcome #1 in the UEEC study protocol are efficacy related, the Secondary #2, #3, and #4 outcomes are all safety outcomes and are of critical importance for FDA approval. The October 18th PR only addresses success of the Primary outcome and Secondary outcome #1. The PR didn't say if the study has shown a non-inferiority or superiority of HemoStyp vs Surgicel in the secondary outcomes #2-4. The history of UEEC only disclosing positive news makes us believe that the omission of results relevant to outcomes #2-4 could have been on purpose, because the clinical study likely showed the inferior performance of HemoStyp vs Surgicel in these outcome measures.
The statistician was very specific to claim non-inferiority and superiority of HemoStyp only in the initial hemostasis after application of HemoStyp to the wound. It is silent on what has happened after the initial hemostasis was achieved.
HemoStyp, according to UEEC, quickly dissolves in an aqueous environment due to its unique degradation properties. We can find this on the company’s website.
From UEEC’s product testing page:
The data obtained during analysis of sample UHP Box of 2” x 2” Pouches indicates the material begins to dissolve in water within one minute. The sample is completely dissolved within 24 hours. Not enough material remains for analysis at the 24 hour time point.
If HemoStyp dissolves too soon, the surgical wound would start bleeding again, and this would be a very serious safety issue.
Imagine a major disaster when bleeding re-occurs after the surgeon has already closed the outmost patient skin layer! The outcomes 2-4 directly address this key safety concern, describing in quantitative terms how well the initially achieved hemostasis is maintained during the surgery. Outcome 4 is about the failure of initial hemostasis, as measured in reoperations, during the one month after surgery. It seems to us that a hemostatic agent that is quick to achieve initial hemostasis, but rapidly dissolves and may frequently fail later resulting in recurrence of bleeding, is a major health hazard. Why would the FDA approve HemoStyp, if it indeed fails to maintain hemostasis, knowing that Surgicel is already a reasonably effective and safe FDA approved product?
From all these observations, we conclude that the clinical study of HemoStyp versus Surgicel was likely a failure. However, if and when its PMA application" gets rejected, 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.""
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.
The Substantive Review is an FDA redo!
As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market its HemoStyp products for human surgical procedures in the United States.
.https://www.globenewswire.com/news-release/2021/12/22/2356825/0/en/United-Health-Products-Provides-Regulatory-Status-Update.html
$5-$10++
Just like a redo of work already performed FDA is once again doing their substantive review. That has already been performed.
https://www.globenewswire.com/news-release/20...pdate.html
Like a learning curve FDA knows the company and the prior work performed like an audit!
12-22-21
As previously disclosed, UHP's PMA application is currently in Substantive Review by the FDA. Receipt of a PMA is a condition to the company's ability to market its HemoStyp products for human surgical procedures in the United States.
Approval within 45 days!
$5-$10++
Investors Hangout: https://investorshangout.com/post/view?id=6682448#ixzz8WW5XUAma
Yes, that’s true but it doesn’t take into consideration the new eStar submission platform.
Why do people keep wasting your breath on a low life piece of s*** I do not know why.
Information provided by - United Health Products, Inc. (Responsible Party)
See the red part? That means it was self submitted and can't be relied on. Because this company lies on everything. The three people indicted for fraud are still lying to shareholders.
Again, which one are you?
Your opinion
Thanks Jimmy.
Very nice post DR
Yes, that’s true but it doesn’t take into consideration the new eStar submission platform. So, I did some investigating of eStar and my impression is that eStar is a comprehensive submission platform that doesn’t allow the submitting company to be less than complete with everything that is needed in order to fulfill the requirements for approval.
After going through a dozen presentations of eStar, I feel that the submission will get a quick turnaround on the necessary info needed to green light the full review. My expectation of approval, if it’s coming …and, I personally think so, is mid to late May …or sooner. I really don’t think the decision from the FDA will go beyond 3 months from 3/21. That’s my educated guess.GLTA!
Long shareholder here. No one has mentioned this, but in the last press release there was a link to the FDA. That link says that the FDA has up to 45 days to basically review the application to make sure all the I's are dotted and T's crossed. Then, if approved it goes into the "real review" of product. So, I think we should hear by May 7ish from the FDA as to whether we passed step 1. Just a guess, DR5 may have more insight...
"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."
And then again the timeline could be much shorter? Does the clock start running on the 90 day period. from 1 the beginning OR since we had already been accepted for substantive review accelerate the time period? Personally IMO it will be shorter!
$5-$10++
Reguritated bullshit. PMA bait & switches since 2017...
https://www.otcmarkets.com/filing/html?id=12414685&guid=4td-kaJ6H_M4B3h#UEEC_EX991_HTM
"FDA Selects HemoStyp ® for CtQ Pilot Program
Henderson, Nevada – December 4, 2017 –United Health Products, Inc. (UHP) (OTC: UEEC), manufacturer and marketer of HemoStyp®, a patented hemostatic gauze for the healthcare and wound care sectors, today announced that it is proceeding with its application for HemoStyp under the FDA’s new and innovative CtQ Pilot Program. The FDA selected UHP’s HemoStyp as only one of nine participants for the program. UHP management has scheduled its first face-to-face meeting with FDA experts for January 17, 2018 to provide the agency with whatever information it needs to advance the application for premarket approval (PMA).
The FDA has stated that it intends to work collaboratively with pilot program participants during the review of their PMA submission to define characteristics of the device that are critical to product quality, and how these characteristics are controlled in design and manufacturing prior to the postmarket inspection. For pilot program participants, the FDA would forego conducting the standard PMA preapproval inspection, and a postmarket inspection focusing on the PMA applicant’s implementation of the critical to quality characteristics would be conducted instead.
The CtQ Pilot Program was created to identify products that have a chemical makeup of demonstrated safe interaction with the body –as evidenced by years of prior product usage and studies-- to be approved for Class III internal surgical use. The program’s intent is to allow products that have demonstrated repeated safe interaction to enter the market in a more efficient manner. This application will run simultaneously with the company’s prior Class II application for expanded indication. The market for 2017 internal surgical market for hemostatic products is estimated at in excess of seven billion dollars, and is expected to grow at 7.1% over the next few years, to reach more than $8.3 billion by 2022. (http://industryarc.com/Report/15189/hemostats-market.html)
Concurrent with its CtQ Pilot Program participation, UHP reaffirms that its current Class II application – Expanded Indication submission with the US FDA-- continues to progress, and is in an advanced stage of review
About Premarket Approval Application Critical to Quality (PMA CtQ) Pilot Program
Top-quality medical devices help the FDA better protect and promote public health. And one of the top priorities for FDA’s medical devices center is a focus on quality.
More specifically, the FDA is working with stakeholders—industry, health care providers, patients, payers, and investors—to build a strong Case for Quality.
This program allows the FDA to identify device manufacturers that consistently produce high-quality devices. By doing so, we can better focus our resources helping other manufacturers raise their level of quality. This program also helps the FDA identify and promote practices that support consistent quality manufacturing, and align our regulatory, enforcement, compliance approaches with those practices.
The FDA launched the Case for Quality in 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. The FDA’s analysis flagged certain widespread or common manufacturing risks that impact product quality. The review also showed manufacturers that focus on and manage those risks often become more productive, receiving fewer complaints, needing to open fewer CAPAs and investigations, and having lower quality-related product costs than their competitors.
In simple terms, the review identified that an investment in quality has long-term payoffs."
For those that are wondering what the process is like for FDA approval for the product, here is a high-level process description with timeline. As you can see, it can take up to 90 days for news.
https://www.hardianhealth.com/insights/how-long-does-an-fda-510k-actually-take
Based on this timing, It may be a great Independence Day celebration for those of us in the US
Primary Strategy (From the 10K) 04/2024
Our HemoStyp technology received an FDA 510(k) approval in 2012 for use in external or superficial bleeding situations and we believe there is an opportunity for HemoStyp products to address unmet needs in several medical applications that represent attractive commercial opportunities. However, the Class III surgical markets, both domestic and international, represent the most attractive market for our products due to the smaller number of competitors offering Class III approved hemostatic agents and the resulting premium pricing for products that can meet the demanding requirements of the human surgical environment. We believe that our extensive laboratory testing and our completed human trial indicate that the HemoStyp technology could successfully compete against established Class III market participants, and could gain a significant market share. There can be no assurance that an FDA Premarket Approval (PMA) will be granted.
In anticipation of receiving a Class III PMA (which cannot be assured), we are evaluating paths to rapidly grow our revenue and profits in all potential market segments, with the objective of maximizing shareholder value. We do not intend to pursue the full commercialization of our products independently nor to remain an independent company in the long term. Options under consideration include (i) a sale or merger of the Company with an industry leader in the wound care and surgical device sectors, which may include a pre-sale collaboration on commercialization and distribution and (ii) one or more commercial partnerships with established market participan
But what is the most alarming to us in the 10/18/19 announcement is that the PR went silent on the very important product safety outcomes. From the UEEC clinical protocol, described on its clinicaltrials.gov page we learned about four secondary study outcomes:
Source: clinicaltrials.gov
While the Primary outcome and the Secondary outcome #1 in the UEEC study protocol are efficacy related, the Secondary #2, #3, and #4 outcomes are all safety outcomes and are of critical importance for FDA approval. The October 18th PR only addresses success of the Primary outcome and Secondary outcome #1. The PR didn't say if the study has shown a non-inferiority or superiority of HemoStyp vs Surgicel in the secondary outcomes #2-4. The history of UEEC only disclosing positive news makes us believe that the omission of results relevant to outcomes #2-4 could have been on purpose, because the clinical study likely showed the inferior performance of HemoStyp vs Surgicel in these outcome measures.
The statistician was very specific to claim non-inferiority and superiority of HemoStyp only in the initial hemostasis after application of HemoStyp to the wound. It is silent on what has happened after the initial hemostasis was achieved.
HemoStyp, according to UEEC, quickly dissolves in an aqueous environment due to its unique degradation properties. We can find this on the company’s website.
From UEEC’s product testing page:
The data obtained during analysis of sample UHP Box of 2” x 2” Pouches indicates the material begins to dissolve in water within one minute. The sample is completely dissolved within 24 hours. Not enough material remains for analysis at the 24 hour time point.
If HemoStyp dissolves too soon, the surgical wound would start bleeding again, and this would be a very serious safety issue.
Imagine a major disaster when bleeding re-occurs after the surgeon has already closed the outmost patient skin layer! The outcomes 2-4 directly address this key safety concern, describing in quantitative terms how well the initially achieved hemostasis is maintained during the surgery. Outcome 4 is about the failure of initial hemostasis, as measured in reoperations, during the one month after surgery. It seems to us that a hemostatic agent that is quick to achieve initial hemostasis, but rapidly dissolves and may frequently fail later resulting in recurrence of bleeding, is a major health hazard. Why would the FDA approve HemoStyp, if it indeed fails to maintain hemostasis, knowing that Surgicel is already a reasonably effective and safe FDA approved product?
From all these observations, we conclude that the clinical study of HemoStyp versus Surgicel was likely a failure. However, if and when its PMA application" gets rejected, 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."
Why do people keep wasting your breath on a low life piece of s*** I do not know why.
Yes that man or woman has some personal issues that require professional help!
$5-$10++
Knock yourself out Sporty. It won't bother me. You never know what you are talking about anyway. It shows. And the stock price will eventually follow the company's performance in any event. You must be feeling a great deal of heat for losing your clients' money on this scam, trying to manipulate the price, and failing to recruit new suckers into this Ponzi Scheme. Show everyone how a spoiled, manipulative broker throws a tantrum. You are intellectually incapable of adding anything of value other than this anyway.
Disregard me. What conclusions have the FDA_&_SEC drawn? Are they verbose negative opinions and conclusions based on what they believe to be facts? Are they to be dismissed?
What you believe to be the reality. What you believe has actually transpired. I am not saying you are wrong. I am not saying you are right. I am simply observing very verbose negative opinions that are conclusions based on opinions of what you believe to be the relevant facts. There appears to be a goal. I’m just not sure what the goal is.
There are longs, myself included, that are in this until the end.
We are not going to change our position no matter what, so this constant bashing of the company and its management gets to be monotonous, redundant and not productive.
I wish you all the best in your endeavors. This post is rhetorical. I don’t need a response, but I am sure I will get one. Good day.
What you believe to be the reality. What you believe has actually transpired. I am not saying you are wrong. I am not saying you are right. I am simply observing very verbose negative opinions that are conclusions based on opinions of what you believe to be the relevant facts. There appears to be a goal. I’m just not sure what the goal is. There are longs, myself included, that are in this until the end. We are not going to change our position no matter what, so this constant bashing of the company and its management gets to be monotonous, redundant and not productive. I wish you all the best in your endeavors. This post is rhetorical. I don’t need a response, but I am sure I will get one. Good day.
What is the reality of what has occurred right along? What has actually transpired?
"From all these observations, we conclude that the clinical study of HemoStyp versus Surgicel was likely a failure. However, if and when its PMA application gets rejected, 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."
Again your opinions and conclusions
The post below describes the "clinical trial" in far more detail than I would. Basically it is a sham posted on a website in which unverified and unreviewed data is posted on the website. The proof in the pudding is that no PMA has ever been approved by the FDA and no FDA document denying the PMA has ever been made available to either shareholders or the public. As I stated earlier; legitimate clinical trials are held at numerous prestigious hospitals with multiple renowned surgeons involved.
"United Health Product’s PRs Describing Its HemoStyp PMA Application Process Are Bizarre, Suggesting A Denial Is Likely
UEEC’s announcement of the PMA submission was released on 10/4/19 stating:
UEEC today announced that it has submitted a Premarket Approval (PMA) application for Class III approval to the FDA for HemoStyp.
This was seemingly very significant news about an important milestone concluding clinical study data analysis and submission. The text of the announcement was, however, very generic and reserved. It further states:
The PMA program confirms the safety and efficacy of a product. If approved, UHP expects that HemoStyp will be authorized for use in surgical procedures in abdominal, cardiovascular, thoracic and vascular surgeries per UHP's PMA filed Instructions For Use.
This October 4th PR mentions nothing about the results of the clinical studies, simply noting that the FDA submission has occurred.
A pre-market application (PMA) application is a very detailed and stringent process. As described in drugwatch.com, the PMA includes:
Source: drugwatch.com
Therefore, the October 4th PMA submission should have included clinical data, including a statistical analysis of its results.
Then, on 10/18/19, a relevant, yet bizarre, PR was announced, claiming positive results of the HemoStyp clinical study. We are puzzled because this announcement comes two weeks after the PMA submission on 10/4/19.
The PR says the final analysis report has been received, and it is from an independent reviewer (does “independent” mean that UEEC didn't pay for this analysis?). It further states:
In summary the independent statistical reviewer (website here) stated:
“For the primary analysis comparing HemoStyp versus Surgicel for hemostasis in 10 minutes, both non-inferiority and superiority were satisfied in both ITT population and PP population. For the secondary analysis, HemoStyp was significantly better than Surgicel with respect to the percentage achieving hemostasis at 2 minutes, 5 minutes, and 10 minutes.”
It further states:
UEEC... today announced that it has received the final report from an independent review of the results of its human clinical trial.
The way the above sentence is worded, it seems as though UEEC had just received the statistical results on October 18 or a day before. It doesn't say that this report was received and sent to the FDA 2 weeks earlier on October 4th. But if it was in fact sent to the FDA in tandem with the October 4th submission, then it is strangely communicated.
Why would they do the analysis after they already sent the application? There is such a thing as a PMA Amendment if the applicant is revising existing information or providing additional information. But UEEC didn’t say that they were doing a PMA Amendment. It is sometimes required to continue statistical analysis after the PMA submission if the clinical study is continuing and the longer patient follow-up is recorded. But according to the UEEC protocol, the follow-up was 30 days and that was finished long ago.
Because this “independent” statistical reviewer apparently gave its analysis after UEEC already submitted its application to the FDA, we would take it with a grain of salt. If it were a relevant review, it should have been included in the PMA application on October 4th. If this analysis was not included, we also wonder then what analysis was included and why the results of that analysis were not mentioned in the PR from October 4th.
But what is the most alarming to us in the 10/18/19 announcement is that the PR went silent on the very important product safety outcomes. From the UEEC clinical protocol, described on its clinicaltrials.gov page we learned about four secondary study outcomes:
Source: clinicaltrials.gov
While the Primary outcome and the Secondary outcome #1 in the UEEC study protocol are efficacy related, the Secondary #2, #3, and #4 outcomes are all safety outcomes and are of critical importance for FDA approval. The October 18th PR only addresses success of the Primary outcome and Secondary outcome #1. The PR didn't say if the study has shown a non-inferiority or superiority of HemoStyp vs Surgicel in the secondary outcomes #2-4. The history of UEEC only disclosing positive news makes us believe that the omission of results relevant to outcomes #2-4 could have been on purpose, because the clinical study likely showed the inferior performance of HemoStyp vs Surgicel in these outcome measures.
The statistician was very specific to claim non-inferiority and superiority of HemoStyp only in the initial hemostasis after application of HemoStyp to the wound. It is silent on what has happened after the initial hemostasis was achieved.
HemoStyp, according to UEEC, quickly dissolves in an aqueous environment due to its unique degradation properties. We can find this on the company’s website.
From UEEC’s product testing page:
The data obtained during analysis of sample UHP Box of 2” x 2” Pouches indicates the material begins to dissolve in water within one minute. The sample is completely dissolved within 24 hours. Not enough material remains for analysis at the 24 hour time point.
If HemoStyp dissolves too soon, the surgical wound would start bleeding again, and this would be a very serious safety issue.
Imagine a major disaster when bleeding re-occurs after the surgeon has already closed the outmost patient skin layer! The outcomes 2-4 directly address this key safety concern, describing in quantitative terms how well the initially achieved hemostasis is maintained during the surgery. Outcome 4 is about the failure of initial hemostasis, as measured in reoperations, during the one month after surgery. It seems to us that a hemostatic agent that is quick to achieve initial hemostasis, but rapidly dissolves and may frequently fail later resulting in recurrence of bleeding, is a major health hazard. Why would the FDA approve HemoStyp, if it indeed fails to maintain hemostasis, knowing that Surgicel is already a reasonably effective and safe FDA approved product?
From all these observations, we conclude that the clinical study of HemoStyp versus Surgicel was likely a failure. However, if and when its PMA application" gets rejected, 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."
You misinterpreted. I quoted you speaking to me and said my opinion was shared by the SEC and FDA.
You are mistaken. I did not share an opinion. I shared a link to a 10K SEC filing, an excerpt from that filing and a link to the clinical trials you requested. I commented that your statement stating the clinical trials are not reviewed was a correct statement. At no time did share an opinion.
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