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"Nobody here is selling"
"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.
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
"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.""
"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."
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."
Same nonsensical bullshit for over a decade. From 2013...
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
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."
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 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."
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."
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