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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.“
That’s Good news.
Interesting though and related to my previous posts. UHP is not shy about announcing positive events.
So, yes this is a positive PR. My question remains valid -“Why haven’t they released Updates on which stage of the PMA process we are in?”
They were quick to announce when the PMA was put on hold due to COVID (reasons to be disclosed) but aren’t updating our movement through the stages.
I’m waiting for a PR that states:
FDA has approved UHP PMA application And will now move on for further review. A final decision is expected within 180 days.
Until I see that PR we are 180 +++days from approval.
I’ve posted the link to FDA timelines previously.
First, Thanks for keeping your replies civil this time.
Let’s use the FDA official timeline. Which is 180 days from when application is accepted for further review.
So if this was a lock for review - the End of Nov 2019 would have started our Official review.
Dec 2019 - May 2020 is 6 months.
Factor in COVID delays of 1 month. Takes us through June.
Factor in 1 month for the “move” from China. Takes us through July.
So August is a reasonable expectation. I completely agree and hope this is the case.
However, this company has a history of announcIng any/all info that may inject some life into the stock:
Article for Peer review submission
Consulting groups Studies
Additions to Board
Defamation lawsuit
Many Human trial updates - when positive.
So why wouldn’t they announce updates on the Approval process if the news is positive.
Because there may not be any.
I’ve owned this stock over 5 years. Back then investors were desperately awaiting news of a major Military contract that would be worth a minimum 400 million a year.
Every now and then a little news would trickle out about potential military applications.
Then we moved to international potential of Hemostyp and put the military on the back burner.
For past two years we are FDA or bust.
So not my first time around this type of UHP Waiting game.
I just like to keep this board level headed. Let’s face it, there hasn’t been a correct timeline guess on here
In almost 5000 posts! That includes me.
92 percent of ACCEPTED applications are approved. Not of all applications.
At this point we don’t know if the Application was accepted or moved onto stages 2-4.
Because this company is always quick to announce any good news and is Typically misleading with the bad news, my guess is that the hemostyp PMA remains stuck in the application phase and is yet to be accepted for further review.
They pretty much have said this (in typical vague UHP fashion) in their latest reports and updates.
Very Educated guess = Minimum 180 days from FDA approval!
This isn’t whining btw. I’m just realistic and looking to a good 2021.
These are the facts as presented.
Dodo, your post sums up the last 30 months of posts perfectly.
Read my posts.
They are crap free. Sorry if I have to repeated expose the companies misleading PRs.
Or debate posters predictions.
Again, read my posts. No fluff.
I know I’d have more pats on the back with “$24 +++“
And “approval is right around the corner”
Or the famous “ human trials will take two weeks tops” line.
I choose to be realistic about the timelines and future PPS.
Not sure what buttons I’m pushing, but You might want to read some of your own comments ....
Like From last week to a respectful / frustrated poster:
“Don't let the door hit you in the ass on the way out good luck “
6 months from announcing Hemostyp PMA Application is accepted is my timeline for approval.
You are correct. Pilot program ended way back in 2018.
UHP never mentioned this in any Follow up PRs so some trusted posters here were still counting on it as a “Fast Track” program up until 2020.
Unfortunately we are left to do this research as shareholders instead of UHP updating previous PRs with completed info.
Until UHP announces that our PMA application has been accepted for further review I believe we are six months from approval.
Save your whining trust - I still believe we’ll get the approval. So I won’t be selling all my shares and going away.
What products were approved faster?
From May 22 8K-A
... It is not clear what the potential effects any such alterations or modifications may have on our business, including the effects on our prospects, although we do anticipate it to negatively impact our financial results and the length of time needed to obtain FDA approval of our hemostyp product for internal surgical purposes during fiscal year 2020.
Try that sentence again.
Or Professor Plum in the Library with the Candlestick.
or More likely one of Rodman‘s burner accounts.
I would say that post was written by a ueec shareholder.
And if forced to guess I would say
Makeihappen7 is also JCmarkets on seeking alpha.
It was a blog post, not an article written or approved by seeking alpha.
“ Please Note: Blog posts are not selected, edited or screened by Seeking Alpha editors.“
Well written though and a good summary of UHP s press releases. With a few good stock references mixed in.
Every bit of good publicity is valuable at this point.
Yes a detailed update is needed.
As It is not a SEC or FDA violation to keep Investors completely up to date with the current status of an application or communications with the FDA.
It is actually encouraged by the SEC so that investors can make informed investment decisions.
What stage of the 4 step approval process was Hemostyp at before going on Hold?
Last weeks PMA devices and supplements Approvals are posted.
Here’s one submitted same time frame as UEEC application was submitted.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190026
Same number of approvals as same week of 2019.
Ok. This really is my last reply.
That was just more of the same babble about a buyer anxiously waiting to sign the papers.
I really hope that’s the case but there info evidence of that.
Never has been.
I would love to see the email response you are talking about.
What email address did you use for “the investment guy”
Ok. My final attempt at logic.
Do you honestly believe acquiring a company is a quick revenue stream??
Should I even have to explain how flawed that statement is?
Closing The acquisition will take 3-12 months.
No current sales means training a sales team on a new product and then actually getting sales.
Delivering on those sales.
Getting paid for those sales.
That’s your “quick revenue stream” ??
Oh ya . One other thing. We don’t have FDA approval yet !
ummm. What? Ok, I’m literally speechless. I give up.
Please refer to PMA database for current PMA approval information.
Here’s an example of a PMA application that was submitted at a similar time as Hemostyp was supposed to be
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190027
And another
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=BP190403
New PMA device approvals are typically uploaded on Monday from the previous week.
Please post a link clarifying when PMA Approvals are being put on hold. Thanks.
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