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It seems that everyone has an idea about what the buyout number will be. Anywhere from $5+ to $12+ seems like. $12 would put the market cap just shy of 2 billion from my back of the napkin math.
Question is specifically for raynbrooklyn but anyone's price target and reasoning would be appreciated. I am curious how you arriving at these price points.
Thank you.
We need more rayinbrooklyns and less rodmans. Great post.
UEEC has a clear pattern. There is a steep run-up caused by people speculating on the timetable of approval. Those individuals so far have been incorrect in their timetables and the stock slowly trends back down and or sideways as those investors get impatient and chase other opportunities.
There is no grand conspiracy to clip shares at a marginal discount. Put your tinfoil hat away. There will be red days and there will be green days but at the end of the day, I am confident UEEC will get where it is going. And it is going through the roof. Good day.
It seems that the FDA may not be doing site inspections during covid. Several large-cap biotechs are unable to get site inspections done. This could explain the delays we are experiencing.
I don't have a crystal ball but I suspect the delays we are seeing may continue for some time. That said I could be wrong and approval could come any week now. I won't be selling any shares still have a strong belief in the product but the timetable is something I have no idea when it will happen.
As much as people hate on management there's nothing else that can be done from their end approval-wise. A substantive update would be nice tho. FDA needs to pull its head out of its arse.
https://www.biocon.com/biocon-biologics-statement-on-the-status-of-bevacizumab-fda-action-date-in-dec-2020/
https://www.benzinga.com/pressreleases/20/11/b18529848/fda-defers-approval-of-daxibotulinumtoxina-for-injection-in-glabellar-lines-due-to-covid-19-relate
https://www.businesswire.com/news/home/20201026005289/en/
Something interesting I found. The link below provides information on other drugs/devices seeking FDA approval. Timetables are only for NASDAQ large cap companies so nothing on there about UEEC.
However, what I found interesting was that all non COVID applications have been delayed. Many have been delayed since October 2020. Expected ruling dates delayed by over 4 months now in many cases.
I don’t know what to feel about it honestly. I take it as good news because it gives a good reason for the delay and management missing prediction timelines. Could also be potentially seen as a negative due to the fact that many others are in line for review as well.
https://www.biopharmcatalyst.com/calendars/fda-calendar
It’s official. When there are no posts during the day the stonk shoots up. When there are posts it trades sideways/down.
I propose we all shut up. Foolproof plan.
And we’re back in the green ;)
It is interesting to me that for all the talk of management not being active enough in releasing PR and keeping shareholders updated, the stock trades downward on positive news. Isn’t the news we are looking for but still news.
Maybe this isn’t the best way to think about it. I’m not as disappointed with management as many on the board but still certainly isn’t something I’m overly confident in due to all the reasons posted on here constantly. Maybe it’s overblown maybe it’s fair critique.
But at the end of the day to me it doesn’t even matter. I believe that the product speaks for itself. Not just in it’s current gauze form but in its powder and gel forms as well. The fast acting nature as well as it’s ability to absorb completely in the body and other unique properties far outperform anything that I have been able to find on the market today. And will certainly be far superior to any gauze/hemostatic products that have obtained FDA approval.
Simply put, I believe in the product. Everything else to me is just noise.
It’s unproductive
Exactly! What wave said. More on the process here
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process
Also, To help you sleep at night we made it past step one and the FDA accepted our submission. I’ve posted this before but 98% of Class III application submissions that make it to the review process ultimately gain approval.
https://www.drugwatch.com/fda/premarket-approval/
“But as rigorous as the process is considered, manufacturers virtually always get the green light if they get over the first hurdle of persuading the FDA to accept and file their applications. According to one analysis, nearly every premarket approval application accepted by the agency in 2015 was granted — a 98 percent rate. As of March 2017, the rate was 100 percent, according to FDA data“
Trust the process, there is nothing more the company can do at this point it’s just a waiting game. Getting impatient and selling pre approval would be a huge mistake. IMO
Get ready for the ride. We about to rip. Biden dollars go brrrrrrrr
The period of time we are currently experiencing is the kalm before the stonks.
Something of note with the FDA and the clinical trial. The only comments left by the Quality Control Review panel reads:
"Quality Control Review Comment provided by the National Library of Medicine:
The description of the scale or categories does not include sufficient information to understand the results reported."
The only point of clarification still needed by the FDA was the way UHP represented the rate of bleeding at the target areas. Frankly doing a web search the "Lewis Bleeding Scale" brings back 0 results other than PR released by UHP which is odd. However, it was the third party that conducted trials that used this scale. Should be an easy fix via conversion to a more universally accepted measure of internal bleeding such as the Bleeding Assessment Tool (BAT).
The results were submitted to clinicaltrials.gov on September 2, 2020.
The press release states they expect the trials to become viewable to the public "these results are expected to be made available to the public within 7-14 days". Press release dated September 10, 2020.
We should expect the trials to be posted before the end of the week.
A few things I have been thinking about.
1. Study to be posted claims to demonstrate "statistically superior" results compared to J&J's ETHICON (Surgical) product.
2. ETHICON (Surgicel) is the market leader in a rapidly growing industry worth billions anually.
____________________________________________________________________
1.
"The results of this study demonstrate a statistically superior performance of HemoStyp over J&J’s Ethicon’s SURGICEL Original product. UHP will be submitting final documents requested by the FDA in conjunction with its PMA (Class III) application to use HemoStyp in internal surgeries. The company expects the FDA to seek additional information or approve the file within 30 days following the submission of the final documents."
____________________________________________________________________
2.
https://www.prnewswire.com/news-releases/jj-hill-rom-and-four-other-companies-dominate-wound-care-report-300404950.html
"It is anticipated that Ethicon will remain the leader in the market but it must continue to offer new innovations that capture the essence of the market either by developing them in house or acquiring technology from one of the many smaller niche companies operating in this market."
____________________________________________________________________
Seems to reaffirm the company's strategy and the need for continued innovation not just for J&J but all the other large caps competing for market share. I will be eagerly awaiting reading the published study as well as any further updates from the FDA.
____________________________________________________________________
Current Market Cap: ~170MM
Specific Addressable Markets:
Hemostats:
https://www.databridgemarketresearch.com/reports/global-hemostats-market#:~:text=Global%20Hemostats%20Market%20is%20expected,rising%20number%20of%20surgical%20procedures.
Hydrocolloids:
https://www.grandviewresearch.com/industry-analysis/hydrocolloids-market
I find it funny that the bid-ask spread is .78 and $2
Stock craters for months. Pops 50% in the two weeks leading up to good news mentioning positive trial results being posted and communications with the FDA. I think some big fish might know something the rest of us don't.
The only part I don't get is that UEEC is down today?
Question for some of those who have been hanging around here for a long while...
What was the specific reason the stock shot up to over $2? Looking back at the company press releases I can't really pin down a reason for such a jump.
Many that are active in the chat and definitely the market, in general, getting impatient as to why the FDA approval is taking "so long"... It's just not, here why.
"According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months."
PMA submission was completed in November of 2019. As of today, we are just now approaching 8 months since submission. We are right on schedule... Add into that possible/probable COVID delays I'd guess that may push approval a month or two back. We are getting very close. If you can't stomach some turbulence you shouldn't have bought a penny stock in the first place.
P.S. From the same article (posted in 2019) "Currently, 92% of PMA applications are approved by the agency." I like those odds.
https://www.qualio.com/blog/fda-medical-device-approval-process#:~:text=process%20to%20take.-,How%20Long%20Does%20the%20FDA%20Medical%20Device%20Approval%20Process%20Take,is%20not%20a%20fast%20process.
I've made this point before, but I can not explain the downward/sideways trading that has occurred over the past 6 months specifically since October when the PMA submission occurred. PMA approval rates range from 85%-98% based on the year. Since the time of PMA submission in October, the stock has been cut nearly in half.
IF APPROVED, a market-leading product in a rapidly growing multibillion-dollar space. Can't figure out what's been driving the last 16-month roller coaster we've been on. We should be close barring any massive COVID related delays.
Also F&*K COVID.
https://www.massdevice.com/fda-pma-time-to-approval-at-record-levels/#:~:text=The%20FDA%20reported%20a%20significant,for%20the%20federal%20safety%20watchdog.
"The FDA said its percentage of PMAs approved dipped to 91% in the 1st 3 months of 2016, a 7% fall from its record high 98% approval rate in 2015. The numbers are still 5% higher than they were in 2014 at 86%."
On the contrary. This is an excellent analysis for the company and its objectives. Let me explain why.
The clinical trial that is the basis of our FDA class 3 approval can be found here:
https://www.clinicaltrials.gov/ct2/show/NCT03654560?term=hemostyp&rank=1
In this report, the study found that "For the primary analysis comparing HemoStyp versus Surgicel for hemostasis in 10 minutes, both non-inferiority and superiority were satisfied in both ITT population and PP population. For the secondary analysis, HemoStyp was significantly better than Surgicel with respect to the percentage achieving hemostasis at 2 minutes, 5 minutes, and 10 minutes."
Surgicel is the market-leading product in the space owned by J&J. The trails (performed by a third party) if confirmed by the FDA give this company an undeniable edge over a market-leading product in a growing industry that will be in the BILLIONS of dollars annually within 5 years.
If that is not an extremely attractive acquisition opportunity for these large medical companies than I don't know what is.
Do you have contact information trust? If so please send my way.
Not saying you/he are wrong but there have been approvals as recently as yesterday per FDA website.
Not sure what to make of that but its one of the reasons I suspect the FDA may still be doing reviews and approvals.
https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals
The assertion you made that because there is a task force looking into COVID treatments, therefore, delays is silly.
For one the FDA has 15000+ employees they can afford to put together a task force and still do their jobs and secondly, the Center for Devices and Radiological Health (medical device office at FDA) would have absolutely nothing to do with that task force specifically or really anything COVID. They are completely separate...
The reason I question if there will be delays or not is simply that there is a relatively small panel that makes a decision on the PMA and its almost entirely data review and analysis. Things that can be done remotely. But at the end of the day its government so you never know and things are probably being done the most inefficient possible way.
I don't know and neither do you.
Also, I'm terribly sorry that your Amazon package took a whole three days to arrive during a pandemic and protests/riots in basically every metropolitan area in the country. Stay strong big guy you're going to make it
I don't know exactly how much COVID has impacted the FDA's day to day operations, but for what it's worth the PMA was filled 09/19/2019. That would be precisely 263 days ago. About two weeks from the average approval time for PMA approval for medical devices back in 2015. That's according to remarks made by Jeffrey Shuren, director of the Center for Devices and Radiological Health to Congress in 2017.
Note: CDRH is the office at the FDA that regulates medical devices.
It could be getting dangerously close to approval... or COVID could be slowing things down a bit. Honestly don't have a great read either way.
SOURCE:
https://www.drugwatch.com/fda/premarket-approval/
"In 2009, Shuren noted, it took an average of 427 days to for a decision on PMA. By 2015, that average was 276 days, a decrease of 35 percent in six years."
Where are you getting these timetables? Could you provide any links to where you are finding this information?
I could certainly be misinformed I am no expert in the FDA approval process. However, my understanding is that the FDA is under no time-sensitive guidelines to approve or deny any application of any kind. Much less approval of a Class III medical device - Being that the Class III classification is for riskiest devices and the hardest process to get approval by.
Anyone else have any insights or opinions on this issue?
"In 2009, Shuren noted, it took an average of 427 days to for a decision on PMA. By 2015, that average was 276 days, a decrease of 35 percent in six years.
In contrast, in 2015, it took an average of 133 days for the agency to reach a decision on 510(k) applications."
via
https://www.drugwatch.com/fda/premarket-approval/
JHOGG, please enlighten me as to what “FDA deadline” has passed. Please tell me
What is uncertain and no one can know is the timetable for approval. What is entirely certain is that the product will be approved. It is entirely possible between now and the announcement many longs will leave to chase other opportunities and we will see short term pressure in the stock price.They will regret that decision.
HODL
I don’t know if this applies and/or if we are already far along in this process. But give this a read and share your thoughts?
“We found, on average, nearly two years passed between completion and publication of clinical trials, across all trial funders. Moreover, given our study was necessarily limited to examining time to publication among completed trials that were eventually published, this estimate is conservative. First, we studied trials registered in and linked to ClinicalTrials.gov, a select group of studies. Because of policies in place as of 2005, many may have been registered to ensure compliance with International Committee of Medical Journal Editors requirements for publication7 and thus more likely to publish in a timely manner. Second, we only studied trials that were published (and indexed via MEDLINE and linked to ClinicalTrials.gov identifiers). Between 50% and 70% of studies registered in ClinicalTrials.gov are eventually published many years after trial completion;3,4 30% to 50% are never published.“
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3691813/
Serious question, with company execs slated to travel to China in the coming month, Does the caronavirus possibly derail/delay those plans?
In the grand scheme of things worrying about if it’s this month or 3 months from now, is not even relevant. Thanks a blink of an eye. Approval in the next month would be SWEET
UEEC TO THE MOOOOOON
As for the time-table, I fully expect that it will take several more months for the FDA approval process to be completed. The manufacturing is yet to be relocated to the US and is still based in China.
From UHPs year-end report, "In January 2020 the company expects to meet with the FDA as part of the normal PMA application process. In addition, in February 2020 management members will travel to China to complete the relocation of the manufacturing operation to Maryland. The entire relocation process, including the installation and testing of production equipment, is expected to take approximately two months."
AT LEAST two/three more months until the US manufacturing process is tested and online. It's just a waiting game at this point IMO
Spot on 59sc. That is the obvious conclusion if you actually READ the article. Rodman’s a jacka$$
Pull your head out of your !:$. Read the article dummy. The article is good news for this company. You are not an intelligent person. Have a nice life!
I’ll save you the click rod pod.
But as rigorous as the process is considered, manufacturers virtually always get the green light if they get over the first hurdle of persuading the FDA to accept and file their applications. According to one analysis, nearly every premarket approval application accepted by the agency in 2015 was granted — a 98 percent rate. As of March 2017, the rate was 100 percent, according to FDA data.
Your conspiracy short talk is laughable every time anything that’s not positive is shared. Retort with research and facts not rubbish. Also, if your barometer for having shares is whether or not you post on investorshub message boards I honestly feel bad for you
Hey Rodman. How bout you re read my post there little guy. Doctors orders.
Price action on this company ahead of FDA approval leaves me scratching my head.
FDA approval on Class III PMA track is upwards of 90% approval rate.
Could be months or even weeks. Patients.
https://www.drugwatch.com/fda/premarket-approval/
Does anyone have an exact date for FDA meeting or is it just undisclosed but in January?
My understanding on the bringing production to the US is because it is required for FDA approval. Product can't be made at a random site in China anymore. Production facility needs to be at FDA approved clean room in order to move forward in class 3 approval process. Can anyone confirm?