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We were “within 30 days of approval” ???
We don’t even know if our paperwork was completed to FDA standard or accepted for further review.
As Last filing said- OUR PMA is on hold.
FDA is still approving non Covid related applications on weekly basis. At about 70 percent of last years week over week rate. But OURS is on hold. Likely because it wasn’t far enough along the approval stages to justify the resources.
When did your trade at 0.57 go through?
A proper pr wouldn’t involve this level of interpretation.
My worry being that it reads “UEEC iis working to advance” as opposed to:
FDA has reviewed our PMA application and has accepted it and advanced it to next stages of review.
Instead I feel there was an issue with the original application and we are at best 180 days from approval.
Which is ok, as there will hopefully be a surge in the market once we are clear of the Virus.
Looks like we were on the same page for once.
When will this board learn to Never Ever trust Rodman.
Rodman (or anyone) please provide a link to the press release stating FDA has suspended ALL reviews.
Thanks.
Moderator ChrisM. While you’ve got the delete button fired up - Any chance you could delete all messages typed in bold font?
Those are the most offensive of all, as poster clearly feels his/her posts are more important than anyone else’s.
I know this is a snarky post.. so I am giving myself a self imposed “quiet time”
SEC quiet time rule??? ... please explain this “quiet time rule” and how it applies to UEEC.
I believe you are referring to a Quiet Period.
Please explain how you are relating this to UEEC.
Thanks.
Go to FDA for FDA questions.
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process
Yes there are deadlines.
1 -45 days after PMA application is received by FDA the FDA must inform applicant if they are moving forward to the next stage.
2 -PMA will either be Approved or Not Approved within 180 days of filing.
Obviously 1 has passed by without an update to shareholders.
Deadline 2 is in May (if we were accepted at stage 1)
Gel/foam/spray is not part of this PMA.
I disagree Trust, that has not been my experience in the modern business environment.
My questions regarding PMA application Acceptance are completely reasonable. Also, pointing out to DR5 that the CtQ pilot program concluded would be helpful to the board. I just wish the company was communicating with shareholders.
I have much more information to share but I don’t since everything gets shouted down by the 3 posters that can’t have a rational discussion.
Disagree Trust, most CEOs and powerful people are NOT “complete low life’s”
You’ve watched too many movies.
Trust, are you suggesting that UHP isn’t updating shareholders on FDA application status because a few people were disappointed in his conference call? Do you think he would deliberately hold back information from the remaining 99% of his Shareholders out of spite towards a few IHUB posters. I certainly hope not.
Then post your opinion and don’t call people idiots, morons, fool, etc. for disagreeing with it.
I’ve never backed down from a bully and I definitely won’t let a keyboard bully spew insults at anyone with a different point of view.
As mentioned before - we need confirmation that the PMA application was accepted and filed by FDA.
Once accepted the chance of approval is virtually guaranteed.
A simple PR at time of acceptance (not approval)will see a nice pps increase. With Approval 2-5 months later.
No need for guessing if UHP communicates.
Don’t worry about Trust. Way back in Summer 2018 he thought Human trials would take a total of 1-2 weeks. Then berated anyone who thought differently.
Rodman’s post was deleted of course.
Dubt, your question is totally legit.
PMA was submitted in Oct but UHP is yet to follow up to say the application was accepted.
Acceptance should be completed within 45 days typically.
The application then moves to stage 2 which is the in-depth scientific review of all data etc.
If the application was accepted I’m surprised it wasn’t announced.
Doesn’t make any difference???
It was the basis of you reasoning for why this would be approved by Mid -January.
DR5, I’ve looked into the CTQ Pilot Program you refer to “Fast Track.”
That program ended Dec 2018. Results of it’s effectiveness can be found online.
It would appear UHP last meeting with CTQ advisors was Feb 2018. For these reasons UHP no longer mentions the CTQ program in updates since their 2018 recap.
Hopefully readers find this informative and if there is conflicting info please post.
Just trying to clear some of the fog and false statements made in posts.
.....
In February 2018, the Company completed and submitted to the U.S. Food and Drug Administration ("FDA") all materials relevant for the pre-market approval ("PMA") for HemoStyp under the FDA's new and innovative CtQ Pilot-Program as a Class III application for internal surgical procedures. The CtQ Pilot Program was created to identify products that have a chemical makeup of demonstrated safe interaction with the body - as evidenced by years of prior product usage and studies - to be approved for Class III internal surgical use. The FDA reviewed UHP's HemoStyp as one of the participants for the program.
.....
PMA CtQ Pilot
? Based on six sigma principle of ensuring awareness of critical features and controls.
? Build on lessons learned from implantable devices with batteries Pilot.
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationa ndGuidance/MedicalDeviceQualityandCompliance/UCM469128.pdf
? CtQ Pilot would allow enrollment of 9 PMAs that meet the enrollment criteria.
? This pilot program is scheduled to run from September 29, 2017, to December 31, 2018
How are you making the connection Hemostyp here?
Seems like a Logical Fallacy to me.
Well, you’ve never been wrong before. Oh wait....hahaha
But I hope you’re right this time.
Stumps question is perfectly valid. So I will answer.
I have sold enough shares to cover my investment and invest in some real estate.
I still hold more than enough ueec for a great payday. Life is good.
I’m guessing most on here are doing similar moves but are part of the silent majority.
Remember when Rodman thought DrStonks was a real doctor.
Thursday, 11/14/19 04:42:08 PM
Re: DrStonks post# 4029 0
Post # of 4313
Lets hope that FDA will also comment about the hemostyp bone study you may recall the use of the gauze showed it did not elevate the PH level that often is attributed to infections. Not a technical type if I am incorrect advise me but this could bolster our acquisition price in a buyout scenario? Thanks Doc!
$10+
I do hope your timeline is accurate. The sooner the better.
But I’ve lost faith in the fast track process on this Submission.
Either way it should be nice ROI in 2020.
Unfortunately the reality is that the final FDA review usually takes 5 to 10 months.
So hopefully we’ll know by March.
At that time the stock should spike and you can sell at market value. Hopefully 3+.
Or gamble and hang on for an acquisition and whatever value you believe that will be at.
So potential Cash out timelines:
-March at post FDA announcement market value
-June at post FDA and potential Acquisition agreement value.
I know what I’m going to do.
I’ve been holding on since 2014. I’ve got a few more months in me.
Firstly, you put way too much trust in a group of keyboard strangers.
Secondly, impossible question to answer.
Kids?
Other Dependants?
Medical bills?
Medical insurance?
Real estate?
Monthly expenses?
Current debt?
Current standard of living?
Registered savings?
Life expectancy?
Charitable donations?
Did you invest heavily in BIEL :) or any other Rodman stocks.
Stonks, Ueec went public as United Eco Energy Corp.
They then bought into Epic Wound Care and over time rebranded as Hemostyp under under UHP.
And here we are today.
Before we go any further here....using YOUR incorrectly three times in one sentence has to be called out.
Here’s Trusts opinion that you’re looking for - from the
Last time you tried to sell QTMM on this board.
trusttheman Tuesday, 08/20/19 05:59:18 AM
Re: superclown post# 2878 0
Post # of 4025
Don't waste your money on that garbage. That's the kind of nonsense daytraders spew. They think there is always some penny stock out there to make a fortune on and tell people to buy them. This stock is a rare gem. These other stocks will just take your money and flush it down the toilet.
So you don’t actually have the authority to speak for the CEO then?
And you personally believe Seeking Alpha hijacked the call by not letting the moderator know how to mute callers? #6 seemed to be the magic formula.
Rodman. Did you just say that you “know Doug would apologize for the annoyance...”
How do you KNOW this. His final comment was “I’M very disappointed in these people.”
DR5 don’t tell shareholders how to think or act. There was one woman on there in the background who was so shocked and clearly saddened by the chaos that she almost hung up. You don’t know her situation. She may have her life savings invested in this company and be terrified that things aren’t going well. She is fully entitled to be frustrated and even concern for the status of her investment.
BTW. Rodman Trust has called you every name in the book on this thread. DR5 he insulted you every time he said most investors are Morons and Idiots who got in too late to realize the ROI the 0.10 crowd will enjoy.
Finally, being a LONG doesn’t mean you hold a stock for a really long time. It’s anyone who buys with intention to sell higher and profit. So who are you referring to as the real longs.
My brother bought at 0.98 and held for a year then sold at 1.04 as he needed tuition money. He just couldn’t wait any longer unfortunately. But he was still a Long.
I’m Shocked! When presented with a different opinion Trust threw another tantrum- took his ball and went home.
He is the exact person he negatively described in his final rant.
For Clarity.
The Stats presented were for the recent Hemostyp gel animal tests. The second speaker clearly stated that.
I have held this stock longer than you Trust and have no intention of selling tomorrow.
I do have the ability to have an open discussion though.
By far the least professional conference call I’ve ever been part of.
When Doug was yelling for everyone to shut up and then told the women who was trying to help him mute the callers that “she should also be quiet” I thought the whole thing had been hijacked by Stumps.
Hopefully that wasn’t the CEO and it was just coincidence his name was Doug.
He sounded like he had been on a Three day bender.
Nice to hear the positive stats though.
And If that woman reads this blog...congratulations you saved the call from complete amateur hour.
Once they finally took your advice and fixed the audio.
A lot more than that are reading it though.
They just don’t have accounts. Plus if anyone sets up a new account and doesn’t fall in line with the usual posters opinions, they get called out as a “short” or told to sell all their shares....like you did when I first joined.
We all would have seen it eventually.
Question is why post a negative article on this board.
Makes no sense. If you don’t believe it’s content don’t give it the opportunity to be seen by more eyes.
But why did you post the article?
Why are you cruising around seeking alpha -coincidentally- the same day the post this negative article?
Rodman, once again you are posting the negative articles from seeking alpha on this board.
Why are you on their site the same day they post the article and why post it here?
Did you make that up? Or actually read it somewhere?
Here’s the facts as presented in UHP pr:
Manufacturers in the EEA and abroad must meet CE marking requirements where applicable to market their products in Europe. A manufacturer who has gone through the conformity assessment process may affix the CE mark to its product. With the CE marking, the product may be marketed throughout the EEA, which comprises 33 countries with a population of exceeding 517 million and a GDP exceeding $17 trillion.