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Why do they call it Ovaltine?
The mug is round.
The jar is round.
They should call it Roundtine.
That's gold, Jerry! Gold!
I never said it would be done on the “up and up.”
Like most of my posts, I simply made an observation based on what can be quantified.
UHP had 12 months to submit the trial results to clinical trials.
They waited until the last Days of 12th month to do so.
How is that the FDAs fault? I’m not even saying it UHPs fault, it just is what it is.
I disagree and don’t mind the discussion. Keep it coming RD. Education and facts always win.
As long as you realize this is one big happily dysfunctional Family.
Complete with grumpy dads, whiny Entitled kids, rich uncles, crazy cousins and squabbling siblings. Possibly a couple peace makers. Like most Apple pie All American Families we hang in there. Keep showing up for birthday parties and reunions. Hoping if we hang stick around long enough without disowning the whole lot, one day we’ll get a piece of GRANDPA’S MONEY!
Also Band aid, the 10Q filed Nov 13 stated:
“As of the filing date of this Form 10-Q, the FDA review process, which was temporarily held up by the Covid-19 pandemic, is ongoing.“
So chances of the PMA being posted this morning were Slim to none. (Not 0 though)
That’s right, but on the positive side UHP could be signing Conditions of Approval today. Then their PMA # is issued and done deal... if you believe Hemostyp has reached that stage in the process.
I wish. But I’m on record many times stating that I believe UHP was actually awaiting application acceptance first. No sense bailing on my theory now.
I feel clearing National Library of Medicine Quality Control Oct 22 sets up for approval WITHIN 180 days from then (WITHIN 160 days now)
On the positive side I would hope for a 2020 PMA.
As always, I hope to be proven 100% wrong (reverse Hubris) on this.
I check every Monday morning hoping to see the Approval.
Thanks, similar to 10K April 2019 and earlier PR. Minus the “drive revenue and profits organically.”
“On October 25, 2018, the Company announced that, in connection with the FDA PMA Class III approval process for HemoStyp, UHP has been contacted by several medical technology companies that are active in the surgical equipment and hemostatic products sectors, and who had expressed an interest in the Company's products and business strategy. In response to these inbound contacts, and to maximize shareholder value, the Company's board of directors has determined to conduct a review of strategic alternatives, which include a potential sale of the Company, joint venture or other commercial partnership, or a standalone growth plan. To assist in this review, the Company has retained Société Générale to serve as financial advisor to the Company and it has retained the law firm of Ruskin Moscou Faltischek PC to assist in the strategic review. There can be no assurances that any specific transaction will occur as a result of the retention of these firms.”
Ha. Good one. Finally the pretend respect I’ve been striving for.
Thanks band aid. This is why they put “Expect“ approval not “will ” within 30 days.
When you spoke, did he mention me?
Oops. There’s my Hubris acting up again.
Weekends not included?
Every FDA PMA comes with conditions of approval. This is a fact. It doesn’t mean there are outstanding issues preventing approval. It is an agreement on the conditions of approval
IE. where an item may be sold etc.
Band Aid ask if UHP would know of approval before a Public Posting. I replied Yes and explained why.
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.