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Do you have a "puffy" shirt?
I want to be a pirate!!
Humility > Hubris
So everyone is ready to jump off the cliff with the latest update, yet the stock price hasn't moved outside of its range for the past several months. What does it all mean? Apparently making millions of dollars on an investment is not as fast and easy as some would like. Patience is a virtue.
There is always a reason.....
There is always a reason.....
I don't know, seems like you did.....
"Do you expect these clowns to satisfy the ringmaster upon their first submission? I don't."
Say what?
Its not their first PMA Submission, please get your facts straight!
Say what?
Savvy investors don't get hung up on the daily movement in PPS when approval will change everything.
That kind of thinking is more dumbass than savvy....
We don't know what he hasn't done, but we certainly know what he has done:
Let me name a few....
Secured needed financial commitments
Met with the FDA several times and has been in ongoing contact with them
Orchestrated the FDA mandated mfg/quality systems requirement and manufacturing reset
Oversaw the production and subsequent testing of "new" Hemostyp in the US
Leading the process of amending the existing PMA submission for acceptance review
And before you @ me, yes he is getting paid handsomely, 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.
Understand the frustration, however he did acquire 10 million in capital with the Triton and White Lion deals, mostly to fund the requirements of the final approval process. Without the money to take care of setting up a quality system and new manufacturing line we would not be where we are right now. The previous manufacturing line in China was shut down long before he got there.
Deplate and the early leadership were great from a technical viewpoint however they made big mistakes on the business and approval process side. These were made long before Thom came on board and its been a catch up process ever since, now it appears there is a clear path to approval.
Better late than never I guess....
You are the best Wave! Thanks for the reaffirmation on eventual approval!
The world is your oyster, you might even find a big old pearl with UEEC.
And since nothing written here is going to change one thing on approval
Positivity > Negativity (aka - your own version of reality)
It's unfortunate you have such a negative opinion on the past meetings and process with the FDA. People see the world differently, and that's ok.
Meeting with them last summer and fall in a further attempt to achieve approval has allowed UEEC to procure the specific requests directly from the FDA panel to complete this process. As I think everyone here knows gaining final approval is a monumental achievement and can take a long, long time. This company was accepted by the FDA for Substantive Review on April 6, 2021, and I believe we are now in an acceptance review stage.
And I see the continual engagement as very encouraging and lets me know we are tracking in a positive direction toward eventual approval.
At any point the FDA could have just said no and declined further advancement of this approval, but that has not happened now has it....
So, what is your answer?
Does the FDA have an additional 180 days upon this re-submission/update including the recent test results on the newly manufactured product?
The PMA has now been submitted and subsequently updated/reformatted based on FDA requests several times over the past year.
That's gonna go unanswered, you see its much easier to comment and say I told you so after things happen than before, predictions actually create accountability
Thanks Wave!
Always remember that Debate > Hubris
The FDA has general policies and guidelines that are applied appropriately to a wide variety of products under approval consideration. It's not 100% black and white.
The fact of the matter is UEEC made a significant amount of this product for the purpose of the extensive trials required for approval. This product was of high quality and used on humans in one of the most successful trials "data wise" you could imagine. It's not crazy or bad business for UEEC to believe it was possible to gain approval without going through making it again in a different US based facility. Importantly they could care less about investing in a manufacturing site when the sole purpose is a change of control.
At that time there was neither the funds available nor the equipment ready to make it anyway. Clearly this was the path of least resistance, and if successful they could be in a great position to be acquired. There is a difference between "lets wing it" and a calculated strategy.
Don't discount the fact that at that point in time, there was really nothing to lose going forward with a meeting to press for approval, worse case they get the FDA to commit to what has to happen for approval and that's exactly what has now transpired with acquiring the money and the personnel to make this happen.
And if you don't think the FDA has been influenced along the way by current companies now in this exact space, you have not been keeping up with the news lately.
As I stated before, the FDA is going to have to come up with something pretty much out of the blue to postpone this decision much further, not even J&J can stop this now.
Thanks for the kind words! It's something I expected and can always count on from you. Most investors and people on this board, including me, thought approval was imminent last year.
In reviewing all of the past events up to right now I stand by my last post as being accurate, and unlike you I am perfectly comfortable saying I was wrong on the timing last year.
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.
As we now know they set it up pretty quickly and produced the exact same product right here in the good old USA.
The company has stated clearly that their entire existence is built around getting this approval so they can complete a change of control transaction. They never wanted to have to acquire all the capital needed for these final steps and create more shares in the process, but that's the way it went down.
Rather than look at this logically and support a life-saving product, the FDA has cost all of us time and money for something that was not necessary.
FYI...I made this response as long as I could because I know how much you enjoy reading :)
I have been offline for a while, but It's time for some perspective.
2 years ago we were still in the midst of Covid with the manufacturing equipment brought back from China packed away in mothballs.
The FDA by its own admission had extensive delays on approving anything not linked to Covid. The company had a CEO change and no operating capital to fund the reset of a production line to reproduce the product state side. They tried to gain an expedited approval based on the fantastic trial data, partly because they didn't have enough operating cash. They acquired some initial money from Triton during this time and more recently have acquired more funding from White Lion. It would have been a better deal for investors if they could have pulled this off rather than dilute the equity by bringing in these current investment partners.
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. All of these activities have brought us to this point, it's really that simple.
I am as disappointed as anyone here on the delays with approval. It would have been nice to see what has been accomplished in the past 6 months done much earlier, however you can't just gloss over all the other contributing factors that were in play on timing and execution. I am not making excuses for this new leadership team, but at the same time for anyone here to think they know more about the process and what has transpired than the key internal players is just foolish.
I can say with great certainty that Brian Thom is much more informed and aware of all the behind-the-scenes details and decisions than any of the Monday Morning QBs on this site.
They have now satisfied all of the FDA's stated requirements. I expect meaningful action and a meeting with the FDA to be set up within a reasonable timeframe. It doesn't mean the FDA can't come up with some added requests, but I can't fathom what they could be at this point.
Its "go time" and ultimately this product will be approved. Schools out on what that means from a PPS standpoint, I have stated several times in the past that I see approval alone pushing the price up more modestly than others ($1.50 to $2 per share), of course I hope for more. But the real share value will come with some type of change of control event that will escalate the price higher and give investors the best opportunity to cash out.
Great score buying those shares!
I see on the board you actually declared being "bearish" what's up with that?
I see you are Bullish on UEEC, kind of cool new feature, it's interesting when I see a Bearish indicator on the board. I thought everyone here owned this equity? Why would someone hold a stock they are Bearish on?
PS: I'm Back!
Phil has left the building.....he gone.
Stay the course all you longs, the day we have been waiting for is not far off and it's going to happen. I have no doubt that our journey is nearing a successful conclusion.
I won't be around for awhile, see you in Q4 when we will all be in a happy place!
Certainly not that the regulatory consultant working for UEEC, and I believe being handsomely rewarded with stock benefits for success, is some kind of double agent steering UEEC leadership in the wrong direction at the behest of J&J. I mean that's a pretty outlandish claim.
I'm as disappointed as anyone that they were not further along with the manufacturing aspects to satisfy the FDA during this last meeting and obtain approval. But my view is that they have been trying to get to the finish line of approval while minimizing further investment in reconstructing the manufacturing set-up they had in China. They figured that they demonstrated the ability to make the product before and came to the meeting with all the theoretical answers to the FDA questions regarding manufacturability and appropriate quality systems.
They just wanted approval granted to get top dollar in an acquisition, but the door got slammed on the short cutting approach and now they have to go the distance to a full manufacturing set up with their partner, it's more time and more money but they have no choice.
The FDA is not approving this product based on the previous manufacturing set up and what a new one will look like in theory, whether its run by UEEC or some acquiring company, they want to see it live and in action and producing the product with approvable levels of safety and quality at a US based facility.
Thats why come hell or high water they need to get this manufacturing line set up and running and why it's 100% an execution story at this point. There is not a lot of mystery to what needs to happen, the presser basically said they know very clearly what the FDA is looking for to approve this product.
I'm with you brother! It's all good, and I'm riding this train all the way to the last stop
Interesting question, the presser said "in the coming weeks" they would work with their manufacturing partner and regulatory consultant toward a successful conclusion.
We don't really know the exact status of production capability right now. Factoring in the probable set up and work needed within the facility, supply chain material aspects, and subsequent FDA review/meeting timeline once completed, I would guess more than 3 months, but less than 6 months until another FDA meeting would take place. I don't think anyone on here, including me, really knows exactly, admittedly this is all just a guessing game on timing right now.
The good news is that this past meeting surely, and once and for all, provided UEEC the marching orders to gain approval, this is 100% an execution challenge to get approved at this point.
The longs need to remember that if this had no chance of approval the FDA would not even be messing around with this any longer, the fact that the meeting took place, and the result was some specific direction toward approval should give everyone the evidence they need to continue to hold this equity to the finish line. As has been stated many times the leadership of UEEC and all partners involved have many millions of reasons to make this happen. They all have a lot bigger payday riding on this than anyone posting on this board.
The only thing the company actually announced was the date of the meeting and the fact that the FDA had no further questions leading into this meeting. Everything else you have read here is pure and utter speculation.
According to the presser this meeting focused on the "procedural" approach UEEC took to address certain observations made by the FDA upon initial review of the PMA.
It states UEEC went thru on a "point by point" basis for each FDA observation and provided responses. Brian Thom commented that the FDA does not respond in "piecemeal" and they have concluded that validation of "certain" elements of the manufacturing process are necessary for completion of the PMA review and subsequent approval.
Translation: UEEC wanted the FDA to consider the prior manufacturing set up combined with answers to all the follow-up details the FDA requested as to how a new US based manufacturing plant would look and operate. The FDA said that's all good, but we want you to validate all of this with a completed manufacturing line before we grant approval.
Interestingly UEEC produced excellent high quality product at their previous site overseas that was used for clinical trials. But that is not going to be good enough to gain approval, call it whatever you want but UEEC has been seeking expedient approval in order to move forward with being acquired and the FDA is basically forcing them to set up a mini plant in order to get that approval.
During the end of 2021 and early 2022 several UEEC pressers discussed commercialization as an option going forward. Although it's still possible they ultimately create a high-volume manufacturing site and hire a direct or contract sales force, it seems much more likely they have been looking for the fastest route to approval in order to sell this company.
IMO they have buyers, minimally seriously interested parties that are in line to acquire the company and all its assets. These organizations appear to be laying low until approval is granted or have offered unacceptable numbers at this point.
Why? Perhaps they already hold market positions and have no reason to jump in early, they may have to pay more later, but with the types of budgets we are talking about who cares about another billion dollars for a fully approved product.
For companies not currently in this exact space it could be simple timing and risk aversion, they aren't offering top dollar until approval is in hand.
As I said yesterday, the update will be out soon but there is still a ways to go for UEEC to complete their success story.....
Its been a fun ride Chris, an update is coming soon, but the completion of this story is still a ways out.
And its never mattered what is written on this board, not a single word
That part about a Trigger Event has got me triggered!
I don't think an unpaid Independent Director agrees to get a million shares if he has to wait for 30 million in cumulative revenue, seems like the talk of "commercialization" is in the rearview mirror at this point.
Whatever run-up happens with approval will be great, but if longs decide they are out at that point I think it would be a major mistake....
As I stated a week or so back, this settlement is nice to have complete, but it will have absolutely no affect on the PPS.
What impact would this decision have on pending approval?
Yes I have done my own DD, seems like a better approach than reading posts on investors hub??
I have consistently said approval will happen and that has not been proven wrong to date.
I don't agree with your assertion that the 180 day clock was re-started due to the data reformatting request completed recently, it may have restarted last fall with the quality/mfr systems request, but the FDA seems to be on their own timeline anyway. Those are all questions that I don't think anyone can answer with 100% certainty
Lastly its not about popularity, I have acknowledged when I thought your posts have been accurate and when I have another opinion.....its really that simple and its nothing personal
That's the great thing about opinions, everyone can have one, and just because someone disagrees that doesn't mean its some kind of competition.
You are correct, they offered the date and UEEC accepted, but you missed the point.
The approach of calling out a date in this release is totally different than in the past where investors would have got an update in mid-July from UEEC that there was a meeting on July 6 and whatever update came from that meeting
You see as opposed to a bunch of investors hearing about things after they happened now there is a date on the books and an expectation of news shortly after, this turns up the heat.
Some people see only black and white, but there is a lot of grey in this world.
Translation: the people at UHP and literally every long-term investor has had just about enough of the FDA and the latest administrative actions that have further delayed this approval. It's time to get back to the irrefutable data and grant approval to this game changing product.
Every press release is reviewed and scrutinized for exact wording and most often there are messages behind the words. If you don't believe that, I can't help you.
Nah, the clock is ticking my friend....and it has been for quite some time!
Interesting presser, as someone that wrote many of these release's I always look for the money line, this was short and sweet, but sending a subtle message by announcing the actual meeting date of July 6 in a very nice way ramping up some pressure.
I don't believe this has happened before with UEEC? In the past they always said "upcoming meeting" or after a meeting they would acknowledge that a meeting took place.
The other interesting verbiage was that UEEC has "accepted " the FDA's offer to meet on July 6.....hmmmm!
May not mean immediate approval is gonna happen, the FDA could come up with another request, but there is not much left to question.
Pigs can fly!!
I don't take advice or make investment decisions from anyone on a message board, bulls or bears, pumpers or shorts, it doesn't matter, that would be a major mistake. Therefore, I don't care about someone else's portfolio or history of success or failure.
UEEC is a high-risk investment, I have said this many times in the past, you don't go fishing on the OTC without the knowledge you might not catch a thing.
At the same time, I wouldn't be here and wouldn't be invested in this equity if I didn't believe strongly that it was going to create a profit for me thru an FDA approval. I have done my research, I have some knowledge that is not in the public domain, and I am here for the duration.
I have also said that approval alone doesn't move the PPS as much as some might think. The real story and potential windfall for investors is what happens after approval.
I see where you are coming from and the logic to get there, but I would add that the updating of GMP software tool "requested by the FDA" on Oct 7 was completed and UEEC followed up with the FDA by the end of October with this formal update of completion.
I guess you could call that a substantive amendment and 180 day clock re-start?
On 12/22/22 UEEC issued a statement saying the FDA informed UEEC that they had no other requests at that time and the substantive review of the application was ongoing. One has to assume that they were fine with all the data and the implementation of this software tool.
Recently on April 1 the press release stated that the FDA met with UEEC in late January and at that time the FDA requested the reformatting of information into the "esubmitter" format, to my knowledge nothing else was requested other than reformatting, I don't think that activity restarts the clock....
Regardless of the semantics and timelines, the FDA is now into a more administrative phase of this review and in my opinion the odds of approval have never been higher.
Hello Wave, glad to see you are back, but I can't say the water here is any less turbulent than when you rode off on your board a few months ago....
This statement needs more context.....
"Nothing has changed since then except they have complied with the FDA request to use eSubmitter online format. (This was optional but should be more efficient ) "
In fact there has been change since the FDA request on quality and manufacturing processes in late 2021, UEEC purchased and began using a software tool focusing on quality and manufacturing processes/metrics, they used some of the money from the Triton deal to accomplish this "request for information" from the FDA.
Earlier this year after a meeting in January, the FDA requested compiling all of the information from the original PMA app with the new information on quality and Mfr into the "esubmitter" online format, this last part was purely administrative
Regarding timeline, I am not sure where you are getting this "major amendment" language from? I would love to hear why you think this has re-started the 180 timeline. I have not seen that language from any official source?
What I see is a "request for more information" which creates a pause in the timeline rather than a re-start, and I have got that from "official sources".
If in fact, as you say, the 180 day clock has restarted AND there are no more requests from the FDA, we are looking at a date of April 20 which puts approval timeline in October of 2022.
Respectfully of course, I don't agree and think we are much, much closer......
Shorts are part of the investment community, don't like their style or the various ways they try to make money, but they have a role and a place in a free market.
However, when they manipulate the market, make up stories, and send goofballs out to post ridiculous crap on investment boards they cross the line and should be prosecuted to the full extent of the law.