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You should probably tag that post with a JMO or IMHO like other posters when trying to blame FDA through unsubstantiated claims.
Fact - the trial results weren’t presented To CT by UPH for Audit until September 2020.
Fact - they didn’t clear Audit until Nov 2020.
These are not FDA or Covid related.
Hemostyp is still months from approval and not due to Covid or FDA conspiracies.
It’s not anyone’s fault....just reality.
Nice essay. However, if you truly know the market you would understand that gauze makes up less than 15% of the market. The majority belongs to injectables, sponges, spays, powders and gels.
It’s hard to take over 25% of the entire market when startOmg from 0. Nevertheless, when at this time only 15% of the market is available.
Yes I am aware of the current PRs stating patents have been filed and RD continues on other hemostyp products.
Your posts remind me of marking the exam of a student who forgot to study and has to make up his points. In light of facts he will throw in pleonasms (babble) to fill the required space.
Quote:
“In my opinion, they are focusing their collective attention on operations pursuant to attaining the results of the clinical trials, as there will be much logistics to work through once HemoStyp receives FDA approval for use in a surgical setting.“
Well Trust, please see below.
I was the first to point this out. The Doctor posted on in a month later.
I am open minded and want only the best for this product.
Waverunners Tuesday, 09/29/20 12:00:58 PM
Re: 3dbriggs post# 5488 0
Post # of 6694
Perhaps even more important, after 2 mins all 118 Hemostyp patients reached Hemostasis vs only 96 for surgicel. And only 110 after 5 mins.
Measured Values
HemoStyp Surgicel
Overall Number of Participants Analyzed 118 118
Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes
Measure Type: Count of Participants
Unit of Measure: Participants
2 minutes 118 96
5 minutes 118 110
10 minutes 118 112
These products already have PMA approval. I put Cryolife as an example of a product in our situation.
But seriously, you allowed yourself to believe there were no products in a $4 billion Market.
You’ve been basing your DD on fluff posters. So that’s on you.
Of course. Clearly there can't be a $4 billion hemostat market without products to service that market.
Currently there are PMA class III foams, sprays, gauze, gels etc.
Cryolab has this one in the running for PMA now as well.
https://www.cryolife.com/products/perclot/
*their not there
Unacceptable. My apologies.
I don’t think so. To be honest, I don’t need to see another PR. I have read the PRs and understand them.
Which is why I know we are very early in the approval process. At best stage 2 of 4.
The problem with your post is that this company isn’t busy in the way you suggest. Other companies have to manage sales and marketing teams. Production etc.
So they can offer shareholder security through that public information.
UHP has no sales or assets and have stated many times in the past that all their eggs are in the FDA PMA basket.
So updates are truly the only way for a shareholder to evaluate the state of there investment.
Blind faith isn’t enough for some.
Kettleman, your post was perfectly valid. There is no need to explain it or back down from it.
UHP can (and obviously has) published many updates on the PMA in the past.
There are no repercussions for this by the FDA or SEC unless they publish lies.
Did you ever hear back on this request for final dates and timelines for FDA approval?
It’s been a few years now.
But they’ve commented on PMA before. Even stating that they expect approval.
That’s where all these unrealistic timeline predictions came from.
Just the opposite. Compared to this week 2020 FDA has completed twice as many PMA reviews this year 2021.
They were through the backlog by August 2020.
FDA is NOT on hold due to Covid.
Integra LifeSciences had their 4 PMA product supplements approved last week.
Also, FYI they purchased Acel for 300 million. Acel does about $100 million in Wound care sales. Integra about $1.5 Billion.
Here’s the #s
Q1-Q2 Ueec had about $15,000 in hand
Earned about $300 in sales
Had negative $1.2 million operating expenses.
Pay Signing bonuses and salaries in RSU.
Float day to day operations on board member loans. Which are typically paid back with RSU s at about $0.50 per.
All perfectly above board and disclosed. Meaning , legit business practices.
Yes, they will need a large injection of Capital.
Hence, the new CEO to make this or acquisition happen.
Now that’s a happy retirement:
Beplate’s retirement from his day-to-day management role with the Company. The amendment accelerated the vesting and immediately settled his remaining Restricted Stock Units (“RSUs”) in a total of 28.3 million restricted shares. Further, as a bonus in recognition of Mr. Beplate’s eight years of service to the Company and its shareholders, including his leadership in the successful recruitment of new executive management to drive shareholder value going forward, the Company has agreed to issue to Mr. Beplate an additional 2 million restricted shares of common stock. As a result of the foregoing stock issuance, Mr. Beplate presently owns 35.8 million shares of the Company’s common stock, representing approximately 16.3% of the outstanding shares.
I can see where it would be frustrating waiting for timelines that don’t actually exist.
As in the post below.
————
rodman Wednesday, 01/22/20 11:30:36 AM
Re: superclown post# 4362 0
Post # of 6417
The company will be sold by 3/31/2020. Mark that down!
$5++
Well done, however you’re being way to politically correct.
The wording of these PRs has resulted in 36 months of shareholders posting that approval is within 2 months.
One positive New Year’s Eve poster made essentially the same predictions 365 days apart...Approval Jan 2020 and now Approval jan 2021.
Is this the opinions of someone who just posts random positive vibe stuff or someone who is desperately trying to decipher the PRs to his/her benefit.
If they present straight up facts then no need for interpretation and certainly no lawsuits.
The second I see the words “may, expect to, in the near future etc” I can feel the smoke getting thicker.
Always, as a skilled linguist I’m sure you are familiar with the phrase - smoke and mirrors.
This sums up my interpretation of the past 5 years of PRs.
They are like a Cliff Calvin Final Jeopardy answer. .. true, but not quite what the educated are looking for.
That said, I have no doubt Hemostyp will be approved at some point.
This was a strong post back in September. It came with the usual negative backlash Etc. Doesn’t seem so outlandish 120 days later though does it.
I continue to wait for IR to inform shareholders that Hemostyp is officially through the application phase and moved on to the in-depth review.
Great post. Who did you talk to? It’s interesting that “the man“ said the FDA is diverting all their “energy” towards Covid but still approved 120 non-Covid related PMA supplements and applications last week.
Also, UHP stated that FDA has requested manufacturing information from them.
This was a great post. A lot of back lash for saying minimum 180 days away.
That was 270 days ago.
I agree, this was an eye opening post when many were expecting approval in Q1 2020.
Great question. Hemostyp is Patented until Oct 2029.
By then it should own 100 % of the market. Every other gauze is the absolute worst!
Including the other two gauzes that also proved superior to Surgicel in head to head trials.
Go UEEC!
Excellent observation mr. fraudster. However, I’m overflowing with optimism and will allow no neigh sayers to infect my bubble. Hemostyp to dominate the 5 billion dollar market and then grow it to 30 Billion through new product launches and superior marketing.
$$UEEC.
$29 +++
Good afternoon E. Great DD. I believe Mr. B. took possession of these shares as of Jan 1, 2020.
For the previous two years he had essentially bankrolled the company on loans out of his own pocket.
Go UEEC. Approval 2020. It’s going to be a green Christmas.
Good Morning UEEC. Hoping for PMA announcement by EOD. Look for a steady rise in pps to Friday and an acquisition announcement in the near term. $11 - $21
Anyone still think we’re within a couple weeks of approval?
Looks like Hemostyp was finally accepted for further PMA review early Dec 2020.
The “within 180 days” to Approval clock I’ve been referencing since January has now begun.
Again, I didn’t want to be right on this fact, but it is what it is:
“We recently re-engaged with the FDA regarding the original PMA submission. During a meeting which took place earlier this month, we were able to confirm that our clinical and non-clinical data and analysis were deemed satisfactory. This position was amplified recently by the acceptance for publication in the Journal of Wound Care of a peer-reviewed white paper authored by Dr. Jerry Abate and members of our human trial team that describes the impressive results of this study. At the FDA’s request we are now pursuing certain manufacturing related testing and documentation, laboratory validations which are essential to establish our Quality Controls & Standards.“
Answer in Previous post.....
The beginning. Electric cars and all.
COCOA, FL -- (MARKET WIRE) -- 05/28/09 -- United EcoEnergy Corp. (OTCBB: UEEC), a Business Development Company (BDC), incorporated in Nevada and with its principal offices located in Florida, announced that it is acquiring Epic Wound Care LLC, a Nevada Limited Liability Company which manufactures an innovative gauze to serve the wound care market. Epic Wound Care LLC manufactures and distributes its proprietary products under its own label, HymoStyp®, and its distributor's trademarks, ActCel®, ActJel(TM), and ABC Gauze(TM). The gauze is a natural product for use in any wound site where bleeding is still present. Upon contact with moisture, the gauze breaks down to form a gel-like substance that acts as a homeostatic agent to stop bleeding. Once bleeding has ceased and coagulation has occurred, the product is then rinsed away with saline solution or lukewarm water.
Epic Wound Care LLC currently has an established distribution network with a worldwide customer base, anchored by Coreva Health Science, and is expanding its marketing efforts into the US and European retail sectors. Kelly Hickel, CEO of UEEC, stated: "It is an exciting time for UEEC and our business development program. We intend to help Epic Wound Care expand its markets for the gauze in areas of personal, retail and institutional wound care management globally. The acquisition of Epic Wound Care LLC by UEEC will allow UEEC to provide the management support and funding capability to enable Epic to expand its product base and increase its revenue potential with new product offerings."
UEEC also announced that it will launch two of its portfolio investment companies in New York City simultaneously on June 3 - 4, featuring the wound care product of Epic Wound Care and the Ultimate Aero Supercar manufactured by Shelby Super Cars and currently holding the Guinness World Record title as the "Fastest Production Car in the World." Shelby's green division, SSC Green, Inc., is also the developer of the revolutionary All-Electric Scalable Powertrain, the AESP whose systems range from 200hp to 1200+hp. For more information on these products please visit www.abcgauze.com, and www.shelbysupercars.com.
The good news is that for those who believe approval is “right around the corner” and that there was a Covid delay; PMAs from the same time period as Hemostyp original application date are getting full approval presently.
In fact, Nov/Dec 2019 applications have been getting approved for months now.
Yes, of course PMA and PMA supplements are still being approved. There is no hold on PMAs.
Here’s one that was submitted around the time many believe Hemostyp was. Nov 2019:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190030
Floseal Hemostatic Matrix had a couple Supplements approved last week.:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990009S061
On a weekly comparison PMAs are coming at same rate as Last Year.
Thank You! Great clarity and transparency on your moves.
Here’s all the details if you like reading:
From last week
https://www.sec.gov/Archives/edgar/data/1096938/000147793220007002/ueec_ex102.htm
The summary I pasted is right there in the Statement of Beneficial Ownership posted yesterday.
Thom’s 11.5 million share vesting schedule:
The restricted stock unit awards vest upon performance and do not contain a conversion or exercise price. 5% of the RSU's vest upon FDA approval of the company's class III PMA, an additional 10% of the RSU's will vest upon the execution of each commercial distribution agreement for the marketing of its products up to a maximum of three such agreements and the balance will vest upon the company achieving $30 million in gross cumulative sales or a covered transaction as defined in the agreement.
A trigger event- like completing an acquisition of UEEC is the quickest route to his riches.
UEEC - FLOAT is approximately 176,000,000 By my calculations.
MoneyRD, no one offered an answer to your question. Not too surprised.
In addition to being paid through shares Thom will Receive 11.5 Million shares As RSUs.
Once these shares are vested they will be added to outstanding shares. An approximate 6% increase in total shares.
You should dig deeper into the RSU Vesting agreement with Thom. It gives great insight into companies growth objectives going forward.
Yes they are being compensated well. Should be noted Thom can be paid in stock if board chooses (which is quite likely as there are no revenues.)
He’ll be paid at a Value of 0.50 per share.
So 30,000 shares a month. Considering shares have recently traded at an average of 1.20, he’s getting $36,000 plus per month.
Note- this is educated observation not complaint or personal commentary.
That delay is due to the plant being in South Korea. Completely different situation.
The beginning. Electric cars and all.
COCOA, FL -- (MARKET WIRE) -- 05/28/09 -- United EcoEnergy Corp. (OTCBB: UEEC), a Business Development Company (BDC), incorporated in Nevada and with its principal offices located in Florida, announced that it is acquiring Epic Wound Care LLC, a Nevada Limited Liability Company which manufactures an innovative gauze to serve the wound care market. Epic Wound Care LLC manufactures and distributes its proprietary products under its own label, HymoStyp®, and its distributor's trademarks, ActCel®, ActJel(TM), and ABC Gauze(TM). The gauze is a natural product for use in any wound site where bleeding is still present. Upon contact with moisture, the gauze breaks down to form a gel-like substance that acts as a homeostatic agent to stop bleeding. Once bleeding has ceased and coagulation has occurred, the product is then rinsed away with saline solution or lukewarm water.
Epic Wound Care LLC currently has an established distribution network with a worldwide customer base, anchored by Coreva Health Science, and is expanding its marketing efforts into the US and European retail sectors. Kelly Hickel, CEO of UEEC, stated: "It is an exciting time for UEEC and our business development program. We intend to help Epic Wound Care expand its markets for the gauze in areas of personal, retail and institutional wound care management globally. The acquisition of Epic Wound Care LLC by UEEC will allow UEEC to provide the management support and funding capability to enable Epic to expand its product base and increase its revenue potential with new product offerings."
UEEC also announced that it will launch two of its portfolio investment companies in New York City simultaneously on June 3 - 4, featuring the wound care product of Epic Wound Care and the Ultimate Aero Supercar manufactured by Shelby Super Cars and currently holding the Guinness World Record title as the "Fastest Production Car in the World." Shelby's green division, SSC Green, Inc., is also the developer of the revolutionary All-Electric Scalable Powertrain, the AESP whose systems range from 200hp to 1200+hp. For more information on these products please visit www.abcgauze.com, and www.shelbysupercars.com.
Rocketman, UHP contact is actually
Phillipe Niemetz. His contact info is on the website and I suggest you reach out to him directly. My previous communication with him have produced little insight beyond what the PRs provide.
I tried to bring in Robert as an outside consultant to help piece together the jigsaw puzzle of information and dates provided over the past 5 years. Unfortunately, he is on contract in Europe With D.Brown Consultants at this time and is not returning calls or emails.
I have reached out to Robert Langdon to help understand the most recent PRs, announcements and recent IH MoneyRD posts.
I’ll follow up once he reports back.