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I suppose this Solid Team has potential to hit both ends of a binary event:
“ When investors and traders hear the term “binary event,” they usually think of biotechnology companies that explode higher after FDA approval, or of a company that had its stock cut in half (or worse) due to mismanagement. ”
They’ve already achieved the latter with flying colors.
The former was handed to them on a silver platter but they seem unable to nail that one down.
Good news for strong team.
Just one more week………,,
Until Thom and “strong team” cash another hard earned check..
Another $15,000 for our leader. I wonder what extra part time work he did to earn it.
Hopefully, more than June 2022 when he prepared (ha ha) for the July FDA meeting.
What is a pr for a CTQ enrolment notice?
The move began Q4 2019 and was completely voluntary, without input from FDA. As we learned in 2022, they may have moved out in 2019/20 but didn’t really move IN to new facility until 2022.
So, other then the Uhaul PO Box the manufacturing was essentially homeless for 2 yrs.
Not smart when your PMA is already submitted based on China’s product.
The reasoning for the move was provided many times…IE:
Dec 2019
Commenced the process of relocating the majority of its manufacturing to a United States facility. Once fully operational, the facility will be capable of manufacturing up to 20 million square inches of HemoStyp gauze monthly. Additional formulations of the HemoStyp product designed for the specialized human surgical market will also be produced at this facility. UHP is onshoring its production operations to improve its order response time, reduce freight costs and improve scalability.
What’s your criteria for a Solid team?
A simple Ihub poster was able to forecast exactly what the FDA required before approval. Yet, their solid team failed to step up and submit a complete PMA. —— repeatedly.
For 4 years I have heard this product described as A market changer, sure thing success. Capable of dominating the Billion $ market upon approval. Yet here we are.
Previous solid team stumbled so a new Team stepped in.
This team has done just enough to earn a paycheque. Always sure to pump a PR when there is something hinting at success in the pipeline, only to announce further delays later on.
Share price under solid team down 85%.
Solid teams are proactive not reactive.
Solid teams work tirelessly to complete a PMA correctly the first time.
Solid teams don’t speak in vague terms.
Two possibilities:
The poor guys gotta eat.
Or, he purposely took the 2022 loss from when he originally acquired them.
He knew he had another batch of 225,000 coming his way on January 13th.
Your link includes approved Supplements to PMA devices.
About 95% of FDA approval work is on PMA supplements. Every change to a PMA device and it’s manufacturing process must be approved.
Here’s the definition of theory from google. So yes it’s a theory. Likely 100% accurate, but still just a theory.
Theory Definition and unbelievably appropriate example from the good old internet:
“”an idea used to account for a situation or justify a course of action.
"my theory would be that the place has been seriously mismanaged"”
I’m not building a case, I’m stating the facts of his contract and aligning them with a lack of accountability. The two work hand in hand.
Somehow, Others see his ridiculous contract and lack of results as a “positive “
I try to let it pass, but my common sense won’t allow it.
Sure did. People in any position are not obliged to quit their job just because they do it poorly.
“Hi SEC, I’m a poster on Ihub and have personally concocted a theory that my CEO sucks at his job and is way over paid. Please open an investigation immediately “…..
5 mins later:
“Dear Mr. Waverunner we’ve completed our fast track investigation and it appears other posters are happy with the CEO and some are down right giddy, so we’re not sure if he should quit or be given a raise. “
“In conclusion, you are an Ihub poster Mr Waverunner (if that’s really your name). Never contact us again and tell Scumbag to lighten up.
What are you talking about. I never said one word about falsifying information.
Does everyone on this board read things and just create their own reality out of it.
Being incompetent is not falsifying information.
On the other hand AlwaysIntheknow did say they have submitted past PMAs to just give it a go. And he felt that was acceptable.
This is of course not what anyone thinks:
“ however for anyone that thinks just stringing this along for a bit more money as opposed to gaining approval for the big enchilada is a real strategy, I can't help you.”
Instead, my comments have eluded to the Fact that he is incompetent and his worst case scenario is that he gets fired and his 11.5 million RSUs become vested. Then when his advisors finally get this done right, he can cash out.
In the mean time he may as well just continue to “give it a go” (as you put it)
And if he is repeatedly sent back to re do the PMA there is no damage to his finances… he continues to collect 15,000 a month and some day will walk away with 22million +++ .
Oberon takes their 50% the Government takes theirs and he’ll still have $5 million+++. So while your investment is currently worth 25% of what it was when he took over, his balance goes up up up.
That’s just painfully boring.
So in other words he did some portions of his job. Yay.
Hence, he can’t be fired for incompetence.
He’s doing just enough to get by.
You nailed it Trust.
Sadly, his contract is so rich I don’t think UHP can fire him.
Good work by his employer Oberon in negotiating that contract for him.
——/
Principal
Waveny Partners, LLC
Jun 2019 - Present3 years 8 months
Greater New York City Area
Oberon Securities, LLC Graphic
Managing Director
Oberon Securities, LLC
Aug 2019 - Present3 years 6 months
New York City Metropolitan Area
Societe Generale Americas Graphic
Managing Director - Head of Americas Corporate Finance
Societe Generale Americas
Jun 2014 - Jun 20195 years 1 month
United States
Everyone knows we are tracking towards eventual approval. I have said that many many times.
Is that positive enough for you.
Did you see my thumbs up.
Yahoooo!
Are you aware that in addition to the $180,000 per yr. Thom makes with this part time job, that his 11.5 million RSUs become vested if he is terminated without UHP proving probable cause.
Unfortunately being incredibly incompetent is not sufficient cause in this case.
So though I once posted that his quickest route to riches was finding a buyer. It could be argued that windfall would come quicker by being Fired.
Old incomplete PMAs mean nothing to the current timeline. Their attempt to Just “give it a go” was a waste of time. The FDA will implement the UP TO 180 DAYS once this is completed and not a second before:
“The company will now incorporate these laboratory results and other data into its PMA application for submission as soon as possible. Concurrently with these final steps for completion of its application, UHP continues to engage with the FDA on various technical aspects of its review process.”
Since they clearly didn’t submit “after a few days “as previously promised, and they have now added the vague -“ UHP continues to engage with the FDA on various technical aspects of its review process.”
They have allowed for an unlimited array of excuses to drag out the final submission.
Once it is accepted as complete I believe the FDA will start its (up to) 180 day review.
At this point they owe UHP NO favors.
Especially after wasting FDA and Shareholder time and resources just “giving it a go”
I’ll give you a tip on how to know when your predictions will be wrong….:
>>When they don’t align with my FACTS.
——-
Is that “black and white” enough for you.
Or Will you need to “read between the lines” some more.
There is no “grey” in that statement.
There is no need for predictions based on someone else’s actions.
I have no control of how they write their PMA and when they submit it.
I only know the standards the FDA expects and the timelines they work within.
A prediction by me or anyone else is meaningless.
When the 100% complete PMA is submitted, we will have an answer within 180 days. That’s a FACT not a prediction.
Anyone can answer all the questions on a Test and call it complete. It’s answering them correctly that gets you an A+.
So far Thom is in the corner wearing a dunce cap.
Of course, when it comes to his personal gain he’s top of the class.
I do respect the contract he and his full time employer negotiated. Absolute genius level.
Did you just say “fast track” ha ha ha ha ha ha ha ha.
There is no “fast track” for a product that hasn’t even been approved yet, nevertheless moved Countries mid approval and failed to submit updated production specs.
Plus, there is NO “fast track.”
There are 30 day notices up to 180 day reviews. I documented our competitors submitting both yesterday.
Here’s an example of a Competitors supplement taking 6 months.
So you see AIK all manufacturers have to follow the same rules:
Device SURGIFOAM Absorabable Gelatin Sponge, U.S.P., SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic MatrixKit With Thrombin
Generic Name Agent, Absorbable Hemostatic, Collagen Based
Regulation Number 878.4490
Applicant Ferrosan Meidcal Devices A/S
Sydmarken 5
Soeborg 08876
PMA Number P990004
Supplement Number S055
Date Received 06/27/2022
Decision Date 12/21/2022
Product Code LMF
Advisory Committee General & Plastic Surgery
Supplement Type 135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement
Approval For An Additional Sterilization Chamber To Be Used For Gamma Irradiation At The Current Gamma Sterilization Site
One more minute and another example of a different PMA competitor having to have all changes no matter how small, approved through supplements.
Device Collastat™ Absorbable Collagen Hemostatic Sponge And Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar Fo
Generic Name Agent, Absorbable Hemostatic, Collagen Based
Regulation Number 878.4490
Applicant INTEGRA LIFESCIENCES CORPORATION
311 Enterprise Dr.
Plainsboro, NJ 08536
PMA Number P810006
Supplement Number S101
Date Received 11/21/2022
Decision Date 12/19/2022
Product Code LMF
Advisory Committee General & Plastic Surgery
Supplement Type 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement
For The Environmental Monitoring Process Qualification Of Room 307, At The Collagen Manufacturing Center (CMC) Located At 105 Morgan Lane, Plainsboro, NJ 08536.
You see, it doesn’t take more than 1 minute to find an example of Surgicel having to submit a supplement for an UPGRADE of just one part of their production process in an already approved facility and process:
Device SURGICEL® Absorbable Hemostats
Generic Name Agent, Absorbable Hemostatic, Non-Collagen Based
Regulation Number 878.4490
Applicant ETHICON, INC.
1000 Route 202
Raritan, NJ 08869
PMA Number N12159
Supplement Number S096
Date Received 11/21/2022
Decision Date 12/20/2022
Product Code LMG
Advisory Committee General & Plastic Surgery
Supplement Type 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement
Changes Related To Improvements To The Splice Detection, Vision System, And Reject Mechanism Of The Automated Foil Sealer Equipment (SL1099) Used To Seal The Foil Pouches At The ETHICON LLC, San Lorenzo, Puerto Rico Manufacturing Site
Yes it would have been nice if the FDA amended their own policies - which are in place to protect the public.
Just so UHP could cut the required corners that ALL companies must take in order to get approval of both PMA and supplements to follow. :
“ It would have been awfully nice if the FDA would not have made UEEC jump through these last hoops only to re-prove what was already known about the product through the trials. One of the advantages of this product is the production aspect is very simple, and the manufacturing process doesn't have all kinds of variables. I believe this was part of the case that UEEC presented to the FDA and why they had hope for approval without going through it again. ”
So you think the CEO and his team submitted a PMA with the let’s just “give it a go” plan??
As I said, if an Ihub poster KNEW they had to create the sample in the USA then a CEO and his Team should as well. So clearly I am implying that they also knew the sample would be required.
Personally I’m not a fan of the “give it a go” technique you claim they used:
“If you think they didn't realize that the FDA could push back and force them to make the product in the US than you are dead wrong. They gave it a go and when the FDA pushed back, they went out and found more funding to help bankroll both the quality/manufacturing software system and the production set up to satisfy the FDA requests. “
So when you thought all was completed and there was no need for a supplement or extension in timelines back in 2022 Q1 Q2 - what were you talking about at that time???
I remember some gibberish about reading between the lines and more grey than black and white etc.
Try to keep your reply under 1000 words.
Yes you would think an 11.5 million share carrot would keep him moving but that has proven to not be the case.
Remember, this lab test should have been done 2 yrs ago. If an Ihub poster could figure that out in about 5 mins , you would think a focused CEO and team of advisors could have figured it out over 18 months - 24 months.
Considering that UHP is paying Thom $15,000 a month (or compensation of 30,000 shares per month when there’s no $$ in the bank to pay)
He’s doing quite well to just drag this out month by month.
Then eventually, if he can find an acquisition partner, he’ll get his other 11.5 million RSU shares.
Maybe his confidence in finding a partner doesn’t match this boards and he’s quite content milking this cash cow for all it’s got.
Remember, this is only a part time job for him. It’s certainly not filling 40hrs per wk.
Good point. Though they stated that after receiving the lab results that they would submit the completed PMA within a few days, they haven’t earned our trust to believe in these statements.
Looks like I’m getting soft in 2023 and falling for the hype.
This must be how others feel who thought approval was imminent in 2020 to 2022.
Actually Rodman, the purpose of that meeting was to inform UHP how incredibly incomplete their file was and tell them to once and for all, get it right.
The FACT is that they have finally done what they were supposed to do the minute they moved manufacturing out of China.
We are now on a positive path forward.
In UHP own words they have NOW - “submitted a complete PMA application”
So a - Nice reminder that UEEC has FINALLY complied to all specific FDA technical requests! Facts matter!
Shout out to our CEO Thom:
Took over Dec 2020.
Dec 30 2020 - $1.20 pps
Dec 30 2021 - $0.60 pps
Dec 30 2022 - $0.27 pps
Honorable Mention to John Phillips who was brought in to lead commercialization and achieved a whopping $35,000 in gross sales in two years.
You guys are terrific.
That’s extremely positive.
Personally, I would like to thank UHP for this follow up to my March 2022 request without any double talk or vague references. They are starting to listen:
Waverunners Mar 2022
“There is nothing the FDA can do until UHP can prove capable of producing hemostyp gauze in the new facility exactly as they used in the human trials.
As a result, until they get a line running at Strouse (or wherever they intend to make it now) the FDA can not complete the approval.
The only question the next PR needs to answer is when/where will this happen. Even a small sample run will suffice. “
Where in the PR does it say that ONE THING will just take a few days.
I thought it said once they receive the LAB results they will then take a few days to submit to FDA.
————-
Perhaps the lab has returned the results, and perhaps they have taken the few days to submit to the FDA. Fine, So I suppose you could actually make a lucky guess. But there is nothing within any PRs to date confirming this.
UHP didn’t offer a time that the lab would return the results, only that once returned they will then submit to FDA within a few days.
Why would you try to guess the timeframe of a independent lab???
We will be updated as soon as this happens. Could be today, could be in months. Who knows?
I must have missed a PR then. What statement within previous PRs would indicate that the Completed PMA is submitted?
How can you offer a Q1 approval scenario when you don’t know when the lab will return their results. Nevertheless, if those results will be positive.
“The company… is now awaiting external laboratory test results on HemoStyp samples produced under its new manufacturing arrangement. Upon receipt and review of the sample analysis, the company expects to submit its full PMA application within a few days. There can be no assurance that the company’s PMA application will be approved. ”
UHP always reports positive news promptly, so you will know when the lab results are completed and the Full PMA application is submitted.
You will also notice the line in the supplement quoted below:
“Supplement Type- Normal 180 Day Track”
In this case they completed the review in under 3.5 months (within the 180 day window) let’s hope UHP gets the same quick turn around once they submit the completed supplement. Provided it is completed properly of course.
Not to worry Sporty. That is plan C, if all else fails.
So you feel J&J, our UHP FDA consultant and even our CEO are deliberately stalling the PMA which you feel could cost shareholders over $2 billion collectively.
That’s very interesting. Bizarre, but interesting.
No coincidence and no conspiracy. Just a poorly submitted PMA by a team that didn’t know they had to file an amendment to original PMA.
Do you still feel that UHP, their consultant and J&J are conspiring to derail the PMA?
Quote
UEEC--Does anyone else find it odd that UEEC management hired an employee of Johnson & Johnson as our, "FDA consultant?" I mean, is this guy incompetent or in on it? How can our soon to be number one competitor in this space, allow one of their employees to advise UEEC?
First off, if he is still employed by J & J, and was brought on as a consultant to advise UEEC management through the approval process, to include manufacturing, then he failed. He should be fired immediately.
Secondly, if it can be proved that he was intentionally leading UEEC down the wrong path with his, "Fabulously wrong consulting advice," then could that be deemed as warranting a criminal probe? Business interference is for sure a civil matter, but can also lead to criminal prosecution.
Was all of this the plan from Johnson & Johnson all along? Did they provide the wolf in sheep's clothing, hoping to stymie UEEC's approval and pick up the assets on the cheap? Why did Brian Thom hire this guy to begin with?
Copies being sent to FDA OIG.
SEC / FINRA
If this was the plan, this post marks the beginning of the end for those in cahoots. I can promise you all that.