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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.
Does this seem familiar. Specifically to the reaction to last weeks PR:
In a pump and dump scheme, fraudsters typically spread false or misleading information to create a buying frenzy that will “pump” up the price of a stock and then “dump” shares of the stock by selling their own shares at the inflated price.
You see, if a shareholder was loading up at 0.45 he then pumps a basic PR to the point of inflated prices. Sells at a 60%ROI.
Pumpers are always waiting for a PR to manipulate.
Then they fake disappointment when it goes back down in attempt to keep their credibility.
It all seemed to start going in the wrong direction on Nov 13 2020. Prior to that we were seeing nice consistency above 1.35.
I just hope we can get back to the highs we saw in Fall 2020.
Is this 16 month old imminent the same as yesterday’s imminent?
It was all uppercase so seemed pretty official.
I’ve outlined the amendments on previous posts. All are regarding manufacturing, raw materials and production facilities.
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 )
You can call Investor relations: Philippe Niemetz to confirm these facts. While speaking with him, can you confirm the production facility status as well please.
Firstly, the 30 day meeting request is standard procedure after an amendment to a PMA. It is certainly not a decision date timeline.
Secondly, UHP has submitted a Major Amendment which, as I’ve explained before, opens a 180 day window from submission.
Thirdly, the PR statement: “at this time FDA has made no other requests” is not a ticket to approval or shortened timelines. It is simply a comment that at this point they feel the application is complete. This comment has made it into many PRs over 12 months and then quoted by posters as a sign of imminent approval.
You can do what you want with those facts.
Disregard this article. Hydrocolloid products are a completely different market segment then Hemostyp. Especially as it moves into the surgical setting.
This article is of no relevance.
In fact, it works against Hemostyp.
A while back he posted a similar article on moist wound care. I let it slide.
Statement of Fact—-No IMO, JMO required.
For factual timeline update, just ask.
This isn’t an either/or situation. I simply used Surgicel Snow as an example of the FACT that other products have proven superior to Surgicel original.
At least 2 other PMA hemostats have also proven superior to Surgicel as well.
I used another J&J Product as an example that there has already been superior product to Surgicel original, yet it remains the standard of care”
I’m so tired of having to explain and then further support my posts.
It’s just not worth it.
The next approval step will take 6-8 months minimum. I see no reason for posting prior to that.
Enjoy your spring and summer everyone.
Ps… someone keeps saying Doug has never sold a single share. Not true. But hey, what do I know?
Pss… most would rather follow the crowd and be wrong, than go it alone and be right.
The only thing is, everyone on here seems to think Surgicel original is the only PMA gauze on the market.
So as soon as Hemostyp is approved it will immediately take over from Surgicel.
Unfortunately that’s not true. There are many Products competing with Surgicel now that also beat them in clinical trials.
If fact, J&J even beats up on Surgicel when promoting their other gauze Surgicel Snow:
“SURGICEL SNoW Absorbable Haemostat
Superior haemostasis (39% faster TTH¥) compared to SURGICEL Original with consistent performance.1* One layer of SURGICEL SNoW is more effective** at achieving haemostasis than 4 layers of SURGICEL Original.2”
What evidence would you like to see?
Do you need my facts to backed up by facts, which you would then call opinions and the cycle would continue.
Outside of posting fda/UHP communications on a message board (never going to happen) you will just have to trust my track record.
No IMO posts, no approval is imminent posts and always able to expose the “writing between the lines” in past PRs.
I have posted many FDA links in the past. These links all back up my Fact based posts. I refuse to repost as you would never do the research.
Re Covid, though I don’t use it as a FDA delay crutch, any reasonable thinker can deduce that some of the delays in approval have stemmed from a Pandemic that dominated the medical community for two years. So a rational person can state as FACT that the FDA experienced delays due to Covid.
See you in a couple months for a follow up.
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.
That inquiry was referring to a previous post where you said
“ Since the FDA usually sends notifications for approval on Thursday’s after market close, I’m keying in on those days for an announcement”
I recognize you said “usually” but if you have any way of backing up the Thursday theory please share.
All FDA PMAs from this week will be available to the public on Monday.
Also, please provide support to your statement that approvals are sent out on Thursdays after markets close. Appreciate it.