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I agree, “mislead”applies more to the PRs. I suppose better wording in regards to FDA would be- don’t underestimate the level of scrutiny the PMA is exposed to. (Don’t cut corners)
Hemostyp is a superior product to Surgicel and under the right guidance it will be a Class 3 gauze.
But PMAs can die on the vine if not managed properly. They will then have to restart the process.
Again, this product will be Approved at some point. I would prefer if it was on this go around.
Positive post coming…I’m not sure why everyone is so shocked by this outcome. On May 24 2022 I wrote:
“I believe even those wearing the thickest of rose colored glasses will read the PR and deduce that UHP is not expecting to leave the meeting with the approval in hand.
Our hope needs to be that they are provided a specific list of hurdles remaining. With that, they can work towards jumping those hurdles in a timely manner.
And if all are crossed successfully approval should be granted on schedule I laid out in post 9247 on May 2nd. “
FDA has. Now provided exactly what I predicted we need in order to move forward in a positive direction.
Though this is not being called an official Approvable Letter DR5 and I had referenced before, it is the next best thing.
My advice is to throw away the timeline predictions and pray that management gets this right. I do believe it’s their last chance. Don’t try to mislead the FDA or your investors going forward. I believe (hope) they have finally realized this and are moving forward in a positive direction.
Rodman, When was the actual FDA walk through?
April 2022
“. The company notes that its manufacturing equipment remains in good operational condition and is on location at the premises of our FDA-approved contract manufacturing partner. The equipment is ready to become operational in anticipation of an FDA inspection and/or the need to produce HemoStyp material for commercial orders.”
BTW this PR came after my March call out. They must be reading my posts.
Hopefully they just need to prove the ability to produce the product.
Meaning, proof that they have sourced the appropriate raw materials and have an approved sterile manufacturing facility on contract.
For example, a manufacturer such has Strouse has already proven to FDA a that they can manufacture sterile bandages so the process would go much smoother with a reputable like Strouse.
Personally, I feel UHP needs to take as much time as it takes to get it right and then they will be approved.
There’s no more room for cutting corners on this submission.
“ their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”
Hopefully 3 months for the paperwork portion. Then the review. Don’t rush it UHP. Just get the approval.
BB you’re new here, but you will soon learn there are no small hurdles when it comes to manufacturing.
As I’ve addressed previously, UHP moved manufacturing post human trials. Hence, they needed to prove they could make the identical product here, with equal raw materials in a factory meeting FDA standards.
UHP failed to disclose the move to FDA in a timely manner which meant the initial process for approval was on dated/inaccurate information.
Therefore, they we’re required to submit a major amendment ( as I’ve outlined and unfortunately been forced to debate here)
The amendment was filed poorly and incomplete by FDA standards which resulted in yet more wasted FDA time.
This PR proves my previous points, and clearly the FDA is saying “ get your manufacturing facts in order and we’ll get this thing APPROVED! But please stop screwing around. “
Note to all:
Stop doubting me.
March 24 2022
As I mentioned before, all delays are manufacturing related.
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.
https://www.strouse.com/
UHP is not currently listed as a partner.
In hindsight they now realize they should have left manufacturing in China active until the PMA was complete and then moved it to the US and simply applied for a PMA supplement to get clearance for the move.
These are statements of fact.
You know what DR5, that’s a solid post.
The approvable letter is precisely what we’re after. As long as UHP has their ducks in a row and responds to the letter in a timely manner, we’re well on our way to PMA success.
Thank You.
Re Trigger Events. I laid this down in Dec 2020:
Wednesday, December 09, 2020 10:44:58 AM
Re: None
Post# of 9620 Go
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.
MoneyMach you are showing the ability to ask relevant questions.
On May 11th someone said:
“UEEC--LOL. When insiders BUY, so should you.”
It traded to 0.78 on the 12th.
It now sits. At 0.35.
CEO has had multiple sells since.
On May 12 another poster said…:
As everyone’s personal research has disclosed. The last insider buy on the Open Market was Oct 19 2021.
At this time Mr Thom bought on the Open Market at 0.95.
This Open Market trade was quite encouraging. However, the stock didn’t hold at 0.95, and started its steady decline into the 0.40s.
So, insider buys (especially on Open Market) are great, but aren’t always a sign that an investor should Buy right away.
Fair response B. I actually agree with you. However this has been acknowledged many times on the board. This stock has been heavily manipulated for years. The same techniques are used to drive it up and down.
Now, regarding my previous post, you should know that I must remain neutral while conducting a scientific survey. I will add b) and c) to your earlier standing.
More importantly,, you will need to tone down the attitude if you want to work at the bake sale. Stale bran muffins have no value.
Thanks for posing the question. It will return some very valuable insights I’m sure.
The bakery is now open.
I’m marking you down as an a) b) and c).
You’re correct. This is a lot of data for one person to control. I can assure you that I don’t take this responsibility lightly. My team is held to a very high standard.
I can see that all of this waiting is starting to stress people out.
Please be patient, a survey this scientific takes time. But in the end it will be worth it.
Great work thinking out side of the box Dark2. I had a good laugh. However, to uphold the integrity of this survey I can’t change it now. Besides, my team is already analyzing the data.
Thanks Lonetree, you just helped guide my future posts. When one improves, we all improve.
I’ll crunch the numbers later on.
Thank You Chrism. I’ll mark you down as e) all of the above.
Your participation is appreciated.
I’m doing a quick survey. Please take a moment to reply, as it’s the best way to improve.
Did todays posts contain too much:
a) math
b) logic
c) DD
d) hubris
e) all of the above
Thank You.
Hello kettleman, the best I can offer you as an explanation is a Mar 2021 quote from….you guessed it: Me.
“At least you’re specifying GAUZE market this time.
Meaning you must adjust your $5.8 Billion sales # as well.
So, 25% of a 900 Million. $225 Million in POTENTIAL sales.
I’m not sure they’ll get a $2.5 B offer for $225 M sales.
Last year J&J offered $400 Million for Tachosil patch which has $155 m in yearly sales.
Fell through, but a realistic example. Real DD matters.
It was a follow up to Feb 2021 DD post:
“… 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. “
Here’s some optimism: Guessing you bough in May at 0.5 to 0.7.
Using your $2-$3 future buyout estimate (thanks for the realistic view btw,) you will enjoy up to a 500 % ROI.
That’s an incredible return for “all this “waiting.”
He was likely referring to these shares:
1)
Includes 200,000 shares of common stock to be sold by John Phillips, which were issued to Mr. Phillips in lieu of cash compensation for services rendered to the Company pursuant to the terms of the Philips Employment Agreement.
(2)
Includes 200,000 shares of common stock to be sold by John Gerhardt, which were issued to Mr. Gerhardt in lieu of cash compensation for services rendered to the Company pursuant to the terms of the Gerhardt Employment Agreement.
Good to hear from you Band Aid. However, I’m hesitant to respond as it typically leads to a firestorm of negativity. But apparently I have an axe to grind, so here goes:
I believe even those wearing the thickest of rose colored glasses will read the PR and deduce that UHP is not expecting to leave the meeting with the approval in hand.
Our hope needs to be that they are provided a specific list of hurdles remaining. With that, they can work towards jumping those hurdles in a timely manner.
And if all are crossed successfully approval should be granted on schedule I laid out in post 9247 on May 2nd.
As an aside, I am marginally concerned that UHP allowed their CE mark to expire without having it extended/renewed. CEs usually run 3 years and can be renewed without difficulty.
So either this was a paperwork oversight on UHPs end, or there is an issue with the manufacturing move.
Hi everyone, I’m just referring back to this post and hoping that all had an opportunity to read it, and avoided overpaying for shares that are now 0.25 cents cheaper.
That’s a savings of 22%. Congratulations.
I’m here if you need FACTS.
Great question Rodman. As you know, in a previous post we were presented 3 posting options: Opinion, insight, or fact. Conjecture is a new posting category. Do you know if it’s been approved yet? Let’s hope so, as I feel it’s very relevant to this board. As it takes into account how one forms an opinion.
Conjecture: “form an opinion or supposition about (something) on the basis of incomplete information.”
Absolutely my friend. He stands to benefit enormously if he can see this through to a successful conclusion.
He is clearly 100% committed, and has deep enough pockets to withstand the delays.
Thanks for bringing facts Lnut. I foreshadowed this amendment last week to much badgering.
I hear you. It’s time for results.
Hopefully the meeting is all positive and outlines the final path to Hemostyp’s certain approval.
You are so right my friend. I actually have a pretty good track record of deciphering PRs. Somewhere around 100% accuracy.
Here’s a breakdown of what I meant.:
ac·cept
verb
1.
consent to receive (a thing offered).
PR”….. UHP has accepted the FDAs offer to meet on July 6, 2022,”
Great news for all. Nice to know the meeting date and avoid further discussion on near term approval dates for the time being.
A meeting date was offered and accepted. No need to read anything into that. It’s all part of the post amendment process and timelines outlined by the FDA.
So true Chrism. Nothing like a beautiful day to remind us of how much we have to be grateful for. For those of you negatively affected by the current chaos occurring here and around the world hopefully better days are ahead.
You’re right my friend. I will have to be very frugal while making my next move.
Timelines are a fickle thing:
Elaine: What time you got?
Kramer: Oh, no. I don't wear a watch.
Elaine: What do you do?
Kramer: Well, I tell time by the sun.
Elaine: How close do you get?
Kramer: Well, I can guess within an hour.
Elaine: [scoffs] Well, I can guess within the hour, and I don't even have to look at the sun.
Kramer: Yeah.
Elaine: Well, what about at night? What do you do then?
Kramer: Well, night's tougher but it's only a couple of hours.
AGREED, but Let’s keep the buzz to a minimum just a little longer. I’m hoping to double my position here if there happens to be a dip.
Agreed. I plan on living large in retirement. I only have 243 shares so I’m hoping for a $12 Trillion buyout. Come on FDA, time to start working weekends and get this done.
Agreed! I would take it further and say the move up has been parabolic! Up 40%+ in under three weeks.
As everyone’s personal research has disclosed. The last insider buy on the Open Market was Oct 19 2021.
At this time Mr Thom bought on the Open Market at 0.95.
This Open Market trade was quite encouraging. However, the stock didn’t hold at 0.95, and started its steady decline into the 0.40s.
So, insider buys (especially on Open Market) are great, but aren’t always a sign that an investor should Buy right away.
That’s sure a coincidence. 300,000 at 0.70 you say.
I was going to highlight the bid for 30,000 at 0.70 total $21,000.
I’m just thinking that this feels more like a closed market transaction.
I’m just surprised that on a day shares were trading on the open market at 0.55 and a week after trading at 0.72 that one was able to buy 300,000 shares at 0.42 on the open market.
Can you confirm that those shares were in fact sold on the open market please.
Are you certain the 300,000 shares purchased at 0.42 were on the open market?
Thank You, my Friend. I do believe the silent majority like different perspectives.