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News is spreading.....
https://www.biospace.com/article/releases/united-health-products-submits-full-fda-pma-application/?keywords=hemostyp+gauze+news
More eyes, more ears, more interest! More money$$$$
$5-$10++
Everything is on the (fraudulent) up and up here. LMAO
"FIRST CLAIM FOR RELIEF
Violations of Exchange Act Section IO(b) and Rule 10b-5 Thereunder
(UHP and Beplate)
SECOND CLAIM FOR RELIEF
Violations of Exchange Act Section I0(b) and Rules IOb-S(a) and (c) Thereunder
(Schiliro)
THIRD CLAIM FOR RELIEF
Aiding and Abetting Violations of Exchange Act Section lO(b) and Rule 10b-5(b)
(Schiliro)
FOURTH CLAIM FOR RELIEF
Violations of Securities Act Section 17(a)
(All Defendants)
FIFTH CLAIM FOR RELIEF
Violations of Exchange Act Section 13(a), 13(b)(2)(A) and 13(b)(2)(B)
of the Exchange Act and Rules 12b-20, 13a-1 and 13a-13 Thereunder
(UHP)
SIXTH CLAIM FOR RELIEF
Aiding and Abetting Violations of Exchange Act Section 13(a),
13(b)(2)(A), 13(b)2)B), and Rules 12b-20, 13a-1 and 13a-13
(Beplate and Schiliro)
SEVENTH CLAIM FOR RELIEF
Violation of Section 13(b)(5) of the Exchange Act and Exchange Act Rule 13b2-1
(Beplate and Schiliro)
EIGHTH CLAIM FOR RELIEF
Violations of Exchange Act Section 13(a) and Rule 13a-14 Thereunder
(Beplate)
NINTH CLAIM FOR RELIEF
Violations of Rule 13b2-2 of the Exchange Act
(Beplate and Schiliro)
TENTH CLAIM FOR RELIEF
Violations of Sarbanes-Oxley Act Section 304(a)
(Beplate)
ELEVENTH CLAIM FOR RELIEF
Violations of Exchange Act Section 16(a) and Rule 16a-3 Thereunder
(Beplate)
https://www.sec.gov/files/litigation/complaints/2022/comp25413.pdf" rel="nofollow" target="_blank" >https://www.sec.gov/files/litigation/complaints/2022/comp25413.pdf[tag]
https://www.sec.gov/files/litigation/complaints/2022/comp25413.pdf[/tag]
The potential for market success of the hemostyp product line may lie in the gel and/or foam applications. FDA has a streamlined approval process for mutiple product devices! Trust The Man stated $10+ for a buyout at one time and he may be correct. Chime in if you can offer information but a buyout of UECC only begins at $5 pps.
$5-$10++
LOLOLOLOL Look at this low lifes, Desperation setting in wasting all his time and energy writing such a large post LO.L.
What A digrace To the human race
More bait and switch deals, contracts, and partners? It's not like United Con Artists doesn't have a long, long history of those. Must be because you won't have to pull out the more testing bullshit and phony FDA requests for a few weeks to kick the can down the road covering up the fact this failed FDA scrutiny.
More news coming folks! Buckle up!
$5-$10++
Naa. shoon gets paid either way. I just figure I’ve learned immensely from him. I just do the opposite of him. Lol
Look at his desperation. SHOOOOOONDALE has to cover.
This is his worst nightmare come true.
BUY / BUY SHOOOOOONDALE.
"Good week board! PMA eSTAR submission is finalized and good volume!"
"Behind the scenes lets speculate that some of the buying was from the likes of White Lion or a similar private placement among many newbies buying in!"
"Brian Thom I believe has much he would like to share so the pps will creep up in the meantime until then."
"I see the FDA decision should be rendered in 45 days best guess."
"Stay the course and watch for more volume and big buys!"
"Congrats!"
Secret "Company" Employee, posing as shareholder, angry about having to dip into his own pocket to keep the artificial share price up with this Ponzi Scheme. Did the Ponzi Scheme have a good week? Since this bullshit sham product has zero chance of ever getting FDA approval, or ever being used medically, it is time to start regurgitating the bullshit PR's about providing the FDA with more info, and pretending it is about to get FDA approval, to attempt to pump up the price. LMAO
I got a kick out of the 100 share ($20) buy at the closing to pump the price to the ask rather than the bid. Carry on with the every trick in the book attempt to groom new suckers in the boiler room and recruit them into the Ponzi Scheme.
pigimon Followers 0 Posts 1 Alias Born 03/22/2024 more phony shareholders out of desperation
Don’t even bother with that POS!
Utter bullshit. The PMA was filed in 2017. Just substitute estar for ctQ, change a few words, and you have the absolute bullshit that came out yesterday. The reality is this is a long ago failed product that will never have any market interest whatsoever. This fraudulent non-enterprise "company" is nothing more than a worthless Ponzi Scheme, using an internet boiler room, to trap a few suckers. This so-called product has already failed Class II, failed Class III, and, as outlined by the SEC in their charges against these fraudulent Ponzi Scheme operators, the product was even a miserable failure over the counter. https://www.sec.gov/files/litigation/complaints/2022/comp25413.pdf. These con artists are just out to steal more of everyone's money, 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."
Good week board! PMA eSTAR submission is finalized and good volume! Behind the scenes lets speculate that some of the buying was from the likes of White Lion or a similar private placement among many newbies buying in! Brian Thom I believe has much he would like to share so the pps will creep up in the meantime until then. I see the FDA decision should be rendered in 45 days best guess. Stay the course and watch for more volume and big buys!
Congrats!
$5-$10++
Last trades: TRADE DATA
DATE TIMESTAMP PRICE $ CHANGE VOLUME
03/22/2024 13:23:46 0.19 0.00 1,000
03/22/2024 13:07:18 0.1899 0.00 5,000
03/22/2024 12:44:32 0.185 -0.00 14,990
Now look at the bid/ask:
UEEC
United Health Products, Inc.
Common Stock
0.19
-0.0026
-1.35%
0.2095 / 0.2097 (1 x 1)
Real-Time Best Bid & Ask: 02:06pm 03/22/2024
Delayed (15 Min) Trade Data: 01:23pm 03/22/2024
TRADE DATA
DATE TIMESTAMP PRICE $ CHANGE VOLUME
03/22/2024 14:08:00 0.2095 0.00 4,000
UEEC
United Health Products, Inc.
Common Stock
0.2095
0.0169
8.77%
0.2095 / 0.2097 (1 x 1)
Real-Time Best Bid & Ask: 02:06pm 03/22/2024
Delayed (15 Min) Trade Data: 02:08pm 03/22/2024
TRADE DATA
DATE TIMESTAMP PRICE $ CHANGE VOLUME
03/22/2024 14:08:00 0.2095 0.00 4,000
03/22/2024 14:06:34 0.2094 0.02 4,990
03/22/2024 13:23:46 0.19 0.00 1,000
03/22/2024 13:07:18 0.1899 0.00 5,000
Explain how cooperating with Ponzi Scheme operators within_internet_boiler_rooms works out in the end? Are the phony "company" employees, posing as fellow shareholders, your friends?
CHARLIESAN
Re: rodman post# 12756
Tuesday, December 19, 2023 12:11:04 PM
Post# 12757 of 13250
Yes, I am a loser; about 800K in this position; and I own a significant amount of shares; in the 7 digits. You must be braindead to think that this CEO and management team do not deserve criticism in their inability to get a PMA filed. They need prodded; pushed; criticized; by any means necessary to accomplish their duties. So you will stand by another year and watch paint dry? Their communication and actions are a travesty and reek of incompetence. Calling it like it is. If you cannot see this you might look in the mirror before denigrating others.
CHARLIESAN
Re: None
Friday, March 22, 2024 11:51:32 AM
Post# 13249 of 13250
Wise board poster awhile back recommended ignoring aholes like shoondickhead; I did and they go away; all I see is your blow back to him. Ignore him and he has no forum. Nuff said.
CHARLIESAN
Re: None
Thursday, March 21, 2024 11:10:33 AM
Post# 13220 of 13251
Added 35 k shares at .19, the negative warnings from the FDA link are standard boiler plate for federal applications; I put no credence in them. Is the selling just "sell the news"? I will be buying more.
Thesaurus English Dictionary Sentences Conjugation Grammar
Synonyms of 'fool' in American English
fool
Explore 'fool' in the dictionary
1 (noun) in the sense of idiot
Synonyms
idiot
blockhead
dork (slang)
dunce
halfwit
ignoramus
imbecile (informal)
numbskull
numskull
schmuck (slang)
simpleton (old-fashioned)
twit (informal, mainly British)
2 (noun) in the sense of dupe
Synonyms
dupe
fall guy (informal)
laughing stock
mug (British, slang)
stooge (slang)
sucker (slang)
3 (noun) in the sense of clown
Synonyms
clown
buffoon
harlequin
jester
(verb) in the sense of deceive
Synonyms
deceive
beguile
con (informal)
delude
dupe
hoodwink
mislead
take in
trick
You’re a despicable piece of garbage!
Wise board poster awhile back recommended ignoring aholes like shoondickhead;
I did and they go away; all I see is your blow back to him. Ignore him and he has no
forum. Nuff said.
Here is the PR...https://www.otcmarkets.com/filing/html?id=12414685&guid=4td-kaJ6H_M4B3h#UEEC_EX991_HTM
Just substitute estar for ctQ and you have the bullshit that came out yesterday. The reality is this is a long ago failed product that will never have any market interest whatsoever. This fraudulent non-enterprise "company" is nothing more than a worthless Ponzi Scheme using an internet boiler room to trap a few suckers. Again this so-called product has already failed Class II, failed Class III, and, as outlined by the SEC in their charges against these fraudulent Ponzi Scheme operators, the product was even a miserable failure over the counter.
"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."
Old news…..douche bag! Nice try, back to your basement.
"FIRST CLAIM FOR RELIEF
Violations of Exchange Act Section IO(b) and Rule 10b-5 Thereunder
(UHP and Beplate)
SECOND CLAIM FOR RELIEF
Violations of Exchange Act Section I0(b) and Rules IOb-S(a) and (c) Thereunder
(Schiliro)
THIRD CLAIM FOR RELIEF
Aiding and Abetting Violations of Exchange Act Section lO(b) and Rule 10b-5(b)
(Schiliro)
FOURTH CLAIM FOR RELIEF
Violations of Securities Act Section 17(a)
(All Defendants)
FIFTH CLAIM FOR RELIEF
Violations of Exchange Act Section 13(a), 13(b)(2)(A) and 13(b)(2)(B)
of the Exchange Act and Rules 12b-20, 13a-1 and 13a-13 Thereunder
(UHP)
SIXTH CLAIM FOR RELIEF
Aiding and Abetting Violations of Exchange Act Section 13(a),
13(b)(2)(A), 13(b)2)B), and Rules 12b-20, 13a-1 and 13a-13
(Beplate and Schiliro)
SEVENTH CLAIM FOR RELIEF
Violation of Section 13(b)(5) of the Exchange Act and Exchange Act Rule 13b2-1
(Beplate and Schiliro)
EIGHTH CLAIM FOR RELIEF
Violations of Exchange Act Section 13(a) and Rule 13a-14 Thereunder
(Beplate)
NINTH CLAIM FOR RELIEF
Violations of Rule 13b2-2 of the Exchange Act
(Beplate and Schiliro)
TENTH CLAIM FOR RELIEF
Violations of Sarbanes-Oxley Act Section 304(a)
(Beplate)
ELEVENTH CLAIM FOR RELIEF
Violations of Exchange Act Section 16(a) and Rule 16a-3 Thereunder
(Beplate)"
"I see you’re still pissing in the wind. I’ve wondered how much you’re making as a “paid hack” for the market makers. It shows your character is an abomination!"
SPORTYNORTY
Re: Scumbag Fraudsters post# 10908
Wednesday, January 11, 2023 9:36:42 PM
Post# 10909 of 12746
Pre-Market Approval NOW CONFIRMED. Thank you.
Looking for UEEC to either be bought out, or announce a deep pocketed partner to finance manufacturing and production. Only going to cost companies more money as time goes. The longer they wait, the more us shareholders make.
"NO!!! one should be reading about any conversations with these people on this board!! Please just set to ignore. Thanks"
NO!!! one should be reading about any conversations with these people on this board!! Please just set to ignore. Thanks
Looking for UEEC to either be bought out, or announce a deep pocketed partner to finance manufacturing and production. Only going to cost companies more money as time goes. The longer they wait, the more us shareholders make.
Suck it Shoondick. You’re all finished. Best go to another board to troll.
Well, the wind is blowing his way so, either way he needs a change of clothing…lol. You can always tell when they’re paid hacks.
I don’t think he’s pissing in the wind. I think he’s pissing on himself. Could only do this for shillings of someone else. Not smart enough to be self initiated. Love how he digs up things from years and years ago. Usually after his 90 year old mother yells down the stairs to tell him soup is ready.
What's not said in the PR is as telling as what was said. No mention of ramping up production in anticipation of approval, to me, indicates they are working a deal to sell rather than focus on production-based growth. eStar should cut 45 days right off the front-end of the FDA approval process (traditionally up to 180 days). With any luck we see an FDA approval before end of June. From there, I would anticipate lots of interest in an acquisition.
I see you’re still pissing in the wind. I’ve wondered how much you’re making as a “paid hack” for the market makers. It shows your character is an abomination!
Boy you are an unemployed headcase! Get a grip boy! Pray and seek help!
$5-$10++
Rodman, Chrism0000, and Sporty have it made!!!!!!!
Patents by Inventor Douglas K. Beplate
https://patents.justia.com/patent/5221277
Diaper construction and method
Mar 4, 1992
A diaper configured with an inner panty enclosed within an outer panty, the inner panty having an absorbent pad inserted in an opening in the inner panty. The inner panty holds the absorbent pad snugly between the legs of the wearer but in spaced relationship to the outer panty. The outer panty is secured around its periphery to the inner panty and encloses both the absorbent pad and inner panty in spaced relationship. The spaced relationship forms an overflow reservoir beneath the absorbent pad.
Diaper construction and method
Jun 18, 1993
A diaper configured with an inner panty enclosed within an outer panty, the inner panty having an absorbent pad inserted in an opening in the inner panty. The inner panty holds the absorbent pad snugly between the legs of the wearer but in spaced relationship to the outer panty. The outer panty is secured around its periphery to the inner panty and encloses both the absorbent pad and inner panty in spaced relationship. The spaced relationship forms an overflow reservoir beneath the absorbent pad.
Diaper with integral overflow reservoir
Apr 29, 1993
A diaper having an inner panty enclosed in spaced relationship by an outer panty. An absorbent pad is inserted in an opening in the inner panty. The inner panty holds the absorbent pad snugly against the perineal region between the legs of the wearer. An outer panty is secured around its periphery to the inner panty. The spaced relationship between the outer panty and the inner panty forms an overflow reservoir for the absorbent pad.
DR5...try not spamming the internet with regurgitated bullshit from 2017
https://www.otcmarkets.com/filing/html?id=12414685&guid=4td-kaJ6H_M4B3h#UEEC_EX991_HTM
Change a few words, and you have the same PMA bullshit over and over.
"You’re done here, asshole!"
"The Bull Shit Detection Rules
No1: Wherever possible there must be INDEPENDENT unbiased confirmation of the “facts.”
That means any research trial published that shows an effect or not needs to be reproduced by another independent party BEFORE we can claim there is or isn’t an effect.
No2: Encourage open honest and substantive debate on the evidence by proponents from ALL sides. This means open, honest, transparent, public debate and discourse is needed by all interested parties regardless of their position or standing, and not only limited to just those with affiliations or connections in closed and private meetings.
No3: Arguments from an authority carry little weight.
Authorities have made mistakes in the past, and they will do so again in the future. There are NO authorities; at most, there are experts, but this still does not make them immune from questioning or challenging.
No4: If there’s something to be explained, think of ALL the different ways in which it could be explained. Think of tests you could do that might systematically DISPROVE the alternatives. What survives among the “multiple hypotheses,” has a much better chance of being the right answer than the first idea that caught your fancy.
No5: Do not to get overly ATTACHED to a hypothesis just because it’s yours.
Ask yourself why you like the idea. Compare it fairly with ALL the alternatives. See if you can find reasons for REJECTING it. If you don’t, others will.
No6: Quantify it.
If whatever it is you’re explaining has some measure, you’ll be much better able to discriminate among competing hypotheses. What is vague and qualitative is open to MANY explanations. Of course there are truths to be sought in qualitative issues, but finding them is more challenging.
No7: Every link in the chain must work (including the premise)
If there is a chain of event or procedures that have to occur to arrive at a result they must all be reproducible, not just most of them. Even if one part of a chain can not be repeated then the result can not be trusted.
No8: Occam’s Razor always applies.
When faced with two hypotheses that explain the data/outcome equally well the SIMPLER one is usually always more correct.
No9: Is the hypothesis FALSIFIABLE?
Ideas and theories that are untestable are not worth much. Others must be given the chance to try and duplicate your experiments to see if they get the same result."
Make a deal United Health! UEEC still maintains a right to sell shares at any time per the White Lion agreement among many private placement investors! NOW who is buying today! HMMMMMMM? MANY!!
LOAD THE BOAT FOLKS!
$5-$10++
Wasn't there some commentary that UEEC's PMA application would receive expedited processing thru the Estar program?
If so that would be a blessing versus the 180 day window. And we need an acceptable application.
Manipulative con men buying above the ask LMAO
UEEC
United Health Products, Inc.
Common Stock
0.2099
0.0089
4.43%
0.191 / 0.1952 (1 x 1)
Real-Time Best Bid & Ask: 11:45am 03/21/2024
Delayed (15 Min) Trade Data: 11:39am 03/21/2024
OPEN
0.1921
DAILY RANGE
0.18 - 0.224
VOLUME
646,314
DIVIDEND
N/A
PREV CLOSE
0.201
52WK RANGE
0.1156 - 0.45
AVERAGE VOL (30D)
126,674
NET DIVIDEND YIELD
N/A
TRADE DATA
DATE TIMESTAMP PRICE $ CHANGE VOLUME
03/21/2024 11:39:57 0.2099 -0.01 447
03/21/2024 11:36:30 0.2198 0.03 400
03/21/2024 11:35:40 0.19 0.00 7,008
03/21/2024 11:33:40 0.19 -0.01 4,992
03/21/2024 11:30:04 0.20 0.01 7,500
03/21/2024 11:23:57 0.19 0.00 10,008
03/21/2024 11:23:52 0.19 0.00 1,950
03/21/2024 11:18:55 0.19 0.00 5,000
03/21/2024 10:46:36 0.19 0.00 30,000
03/21/2024 10:46:36 0.19 0.00 200
BUY BUY SHOOOOOOOOOOOOOOOOOOOOOOOOOOOOONDALE
Funny stuff; made my final purchases for the day; and 3 1 share pick ups were made at the teens.
Someone trying to manipulate. Paying a commission to sell 1 share?
Replace CtQ with eSTAR and get the recent bullshit.
https://www.otcmarkets.com/filing/html?id=12414685&guid=4td-kaJ6H_M4B3h#UEEC_EX991_HTM
ROTFLMAO at the fools believing this bullshit from the United Ponzi Scheme,..and the suckers buying into the Gravy Train.
LETS!!!! HOPE!! for no F!!! UPS!!!
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."
Added 35 k shares at .19, the negative warnings from the FDA link are standard boiler plate for federal applications;
I put no credence in them. Is the selling just "sell the news"? I will be buying more.
Comin to unmask the Shoonpoo and Zoro - your gig is up - Dr Hemo - To the moon Alice!!!
Yes some nuts on this board have posted old irrelevant information all the while not owning shares or have any
interest except their own short seller agenda! UEEC has more to share then the submission!!
$5-$10++
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