UHP will know in advance, as once FDA has cleared Hemostyp for approval UHP will have to sign off on the conditions of approval to make it official.

McKesson is a distributor not a manufacturer.
There is a 0% chance they will be the buyer.

I have posted the Access Data link multiple times. Updates every Monday morning.

Sounds like some good conversations.
Who were you communicating with? What date/month did he say the application was approved for further review? Did he mention why they didn’t announce that approval? As they aren’t shy about communicating successes. Thanks for putting in the effort here.

In response to LRM - Hemostyp did not receive FDA PMA last week.

Are you looking for another extension on our gentlemen’s bet.
Recap :
Original bet oct 9th
Extended to Oct 30th
Extended to Nov 11th.
I accept those new terms. That’s it though.

Clinical Trials doesn’t announce FDA approval. You’ll want to check access data which publishes the prior weeks approvals Monday morning.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm

So if HemoStyp is granted FDA PMA approval (Not application filing) this week it will be posted there on Monday. No exceptions. No Covid delays.

Observations aren’t roadblocks. Also, products with millions in sales aren’t really “pretenders.”

(*sp. Quikclot. ). My # hasn’t changed too much (Maybe plus 15%) since my first post on this thread. That Post brought the typical backlash and I’m not wanting start that up again. So you can always refer to that. Otherwise,I’m just hoping for a timely conclusion.
My goal Is to sell on the hype of FDA approval as I feel that is when the stock will reach max value. I won’t gamble on a buyout as there’s too many factors involved. Unless the buyout comes first of course.

Quick clot Control has a class II FDA approval. Hemostyp was encouraged by FDA to seek PMA Class III approval. A more rigorous and lengthy (as we have witnessed) process. The payoff should be worth it.
This offer at 500 and JJ $400M offer for tachosil set a low bar for acquisitions.

Correct. Hence my previous post outlining this exact course of Events ....

Their 2nd submission to Clinical Trials QC was Sept 27.
The last one took 13 business days for QC review.
Hopefully this one can be done quicker and it’s posted by the end of this week.
From there it’s in FDA hands to accept the application. Hopefully, the 30 days doesn’t start fresh after clearing QC.

Still batting 1000.

That’s not overly exciting.
Self-deletion is a real superpower.
Trumps advisors probably wish they had it.

There really shouldn’t be any confusion about where the APPLICATION stand at this point.
But here it is one more time.

From UHP:
The company expects the FDA to grant approval to its PMA (Class III) application or request additional information within 30 days.

From FDA:
“ The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.“

Rodman, That’s a 400% ROI.
$6 gained on a $1.50 investment.

Their 2nd submission to Clinical Trials QC was Sept 27.
The last one took 13 business days for QC review.
Hopefully this one can be done quicker and it’s posted by the end of this week.
From there it’s in FDA hands to accept the application. Hopefully, the 30 days doesn’t start fresh after clearing QC.

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

Results have been posted.
Pre QC Audit. But all looks positive.

https://clinicaltrials.gov/ct2/history/NCT03654560?V_9&embedded=true

Correct Skiman. Band aid it’s one thing to be optimistic, but to be so far from reality helps no one make wise decisions.
Their own PR states that they still have to submit final paperwork and after that expect a response within 30 days. Even then the expectation is that FDA will possibly request more info Or approve the FILE!!! Not the Product - the file.
If the final paperwork was ready they would have said ...”we submitted’ or even ‘is being submitted
within ___ days.‘

I will state again. Approving the file does not mean that Hemostyp will have FDA PMA approval.
That will follow within 180 days. Facts matter.

I’ll check back in a couple weeks to follow up on the status of a previously agreed upon Gentlemen’s bet.

Yes. We need more miyagi-do and less Cobra Kai

I probably shouldn’t have to apologize for having a different opinion.
But I truly hope you are correct so I will congratulate you for sure. I’d like to close out 2020 on a positive.
Bottom line, we both think approval will come.

After studying martial arts around the world you too would spell it self defence.

Right now UHP is sitting around a Zoom meeting saying “ man we fooled them all except that Waverunners guy again. He’s just not biting. Call in the asset it’s time to end this”

Let’s just say I’ll be locking my doors tonight and honing my self defence skills.

Now don’t go guessing I’m guessing.
That’s double guessing and according to rule 610 the OTC must now shut down.

I wish I was wrong as well. But I’m not.
I suggest you grab a beverage this evening and read through ALL of my posts.
However, the excitement may keep you up all night.

But if you’re not up for that here’s a July post.

Waverunners Tuesday, 07/21/20 10:18:13 AM
Re: Waverunners post# 4991 0
Post # of 5249
Read below from FDA. No need for confusion.
Also in this May 2020 FDA published Update there is no mention of a backlog of applications to to a Covid related hold - so no delays in approval are expected and the 180 review process stands.

“ The filing of an application means that FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. The date of filing is the date that a PMA accepted for filing was received by the agency. The 180-day period for review of a PMA starts on the date of filing.“

Are you ready for a reality check now?
Open your eyes and mind.
This PR clearly states what I have been saying all along.
In 30 days UHP will know if the Application has been accepted(or not)
If the the answer is Yes then and only then will we know we are within 180 days of a final PMA approval.

So Band Aid I won’t be eating my words. And DR5 will be wrong again mid October. Like he was last Oct/Jan/March.....etc.

I want this Approval as bad as anyone here. But as I have repeated proven. The FDA process will be followed and I can’t/won’t be fooled by the wording of PRs.

Strettttchchching reality as per usual.

Nothing. But that’s to be expected as it doesn’t report on ongoing approvals etc.
UHP is free to provide updates though.

This disease is relentless. I can’t believe the toll it has taken on this man and his family. Though my initial interest was due to the RLF connection it is now purely a human interest. This is the closest I’ve been to a Covid patient and it has been incredibly eye opening. I will be praying for Tommy and his family.

Some day you will wake up to a pr stating that our PMA application has been accepted (not approved)
And on that glorious day you will know that within 180 more days you will have your answer.

Below is an Example of another PMA approved within 180 days of application acceptance.
Covid has no effect on this timeline despite March 2020 application date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200015

Applicant
Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614

PMA Number P200015
Date Received 03/09/2020
Decision Date 08/31/2020
Product

This latest submission indicates that the data is now being audited to see if it meets the criteria for further review and start moving through the stages.
Essentially we are still in application stage as I’ve been saying for months.
Re Stages I have outlined the process many times on this board. Check my old posts. No fluff or made up info.

Considering that everything you said in that post is inaccurate I will just end this debate now as it is pointless.

band aid Monday, 03/26/18 12:12:17 PM
Re: rodman post# 1065 0
Post # of 5200
Just bought another 20,000 shares today at.98 FDA approval is soon IMO...

That’s the exact same guess you made 2.5 years ago.
My estimate is based on knowledge of the approval process and where we are within it at this time. Not a popular position to be in with this board but
I can not see any logic behind you guys repeatedly say “approval is close” over and over again without a shred of evidence to back that up.

As I’ve stated before. Hemostyp is still very early in the approval process.
This is a fact. Minimum 180 days away unfortunately. Hopefully, UHP has the financial backing to see this through.

That’s a nice $5Billion Market increase and extra $5Billion valuation based on that $5Billion Increase. All based on a couple possible new launches.
Good logic.

A year ago you claimed this was a 5 billion dollar industry and will sell for 5 billion.
What changed??? Not smart logic or math.
Makes as much sense as the guy that thought human trials would take two weeks tops.

No one ever truly leaves the UEEC board. We’re all trapped in this strange vortex of Potential PRs and FDA approvals.

As long as a therapy drug like RLF-100 works as studies claim, it will remain in demand long after a vaccine is available world wide. This will be standard inventory at all hospitals and medical clinics.
Covid doesn’t disappear with a vaccine, unfortunately it will continue to rear its ugly head for years to come.

That’s a great article by a self described investor(Long) Who’s done his homework.

If you’re waiting for FDA approval that is Feb 2021 at the earliest.
However, maybe we’ll get another run to $2.50 like Aug 2019.
Question is what price are you willing to sell off some shares at?
I’m sure many are wishing they capitalized last year.
Personally I held too long and sold 40% on it’s way down in 1.60s.
My greed cost me about 38,000 on the sale.
All good though as I’ve bought them all back at a nice price and kept the remaining profits in safer investments.
So, what’s your sell price??

Careful lads. You’re cruising for a tongue lashing. According to our resident Matt Foley, shareholders should not expect or request updates. That would be selfish.