Any time we see a PR that states "in the coming weeks . . . " It takes this company 2 - 3 months to actually formulate a plan, respond, get another PR.

With any luck, the FDA 180 clock will start ticking again in September. 2025 Here we come - and that assumes this company does keeping screwing up.

Spot on Wave! I'm sure by this point there have been many communications between FDA and UEEC. What baffles me is the lack of communication, since as you say, no rules issues. Maybe lack of PR / Communications experience by the team has them erroring on the cautious side of any potential SEC hand slap???

Sorry Wave - was trying to lecture. From your posts, you clearly understand where this is in the process.

Now that we know UEEC is in the FDA process, my point - there won't be much to update on for weeks to come. There are some folks here (again not you, or what appears to be the small minority in this group anymore) that seem to expect daily journal entries with updates.

Agree - Now that we know it's in the hands of the FDA, we are waiting on them (well mostly).

As I've stated before. UEEC has zero reason to update shareholders or issue a PR until there is something to actually write about. They are not going to spend money having a PR written that states "Still waiting on the FDA." We must be patient. Patient that the process is executing as it should. That UEEC is providing answers to any questions the FDA may have. That the FDA is following their process, doing site visits as needed, etc.

There is zero benefit for Brian or anyone else at this company to hide information, or slow play this. It's very clear, the eggs are all in one basket . . . getting FDA approval.

Let's all have a bit more patience, and fingers crossed for some good news as soon as the news is actually news and not just rumors or speculation.

Thanks for the clarification. My apologies. I wasn't trying to misinform. I just wanted to help those poster that ask every other day if this is the day :D Just simply showing that 90 days is a realistic best case scenario. To your point, much longer typically.

Given UEEC track record, I'm leaning on the longer end of the stick.

To your point - this may be closer to a Halloween treat than an independence day victory.

Anything sooner and we will all be very pleasantly surprised.

For those that are wondering what the process is like for FDA approval for the product, here is a high-level process description with timeline. As you can see, it can take up to 90 days for news.

https://www.hardianhealth.com/insights/how-long-does-an-fda-510k-actually-take

Based on this timing, It may be a great Independence Day celebration for those of us in the US

The banter is quite entertaining. One the one side there is speculation that this is going to be a big week. On the other side, it's going to be a complete failure and all of us longs are going to lose $$$ bigtime.

Here's the reality. It's in the FDA hands. They have up to 180 days to respond. They can respond as slow or as fast as they like. Until we get official word, we won't know what reality is. Based on this, we will know sometime this year.

Until there is news, we can't expect this stock to do anything other than hover around $0.20

What's not said in the PR is as telling as what was said. No mention of ramping up production in anticipation of approval, to me, indicates they are working a deal to sell rather than focus on production-based growth. eStar should cut 45 days right off the front-end of the FDA approval process (traditionally up to 180 days). With any luck we see an FDA approval before end of June. From there, I would anticipate lots of interest in an acquisition.

assuming your opinions become a reality - and I believe very possible - my vote will be going to selling. A bird in hand is better than two in the bush as they say. I've waited long enough for a return. I don't want to wait another 5 years as they try to raise capital, ramp up production, and go it alone. First buyer that shows up with the money you imply - they get my vote

I'll jump on the bandwagon as well. I've been investing since 2018 and my cost basis is around 0.45

It's becoming more and more clear that Doug was the brains behind the product and getting it across the finish line. Brian was brought in to market the company (for sale or mass production investment dollars). Doug clearly thought this was much closer than it was, and left too soon. As a result, the company is left with someone who knows nothing about getting FDA approval. 8 weeks to review sterilization data and submit is plenty long enough to have given a further update. This tells me that either they submitted and have big news coming, but are fearful of leaks so don't want another PR, or they are clueless on what to do next and are fumbling around looking for a Doug-like expert to bail them out.

Enough is enough Brian - Finish the Deal!

One would hope they are running multiple paths in parallel. Getting this submitted and talking next steps - scale or sale - as I like to call it.

Of course, a PR with updates will end much of the shenanigans being posted on this site daily.

My two cents - we see FDA communication and go right to merger / buyer communications. If their goal was production and sales, we would be seeing indications of that scaling up already. All indications point to a faster finish line to the reward $$$

Was there a PR stating they finally submitted? I'm not finding anything that is able to verify. This would align with the expected timeframe to review sterilization test data and submit.

I would love to see the factual evidence stating it was submitted so a few of the posters on here can finally shut up and start their sad walk away, tails between their legs.

They have. The military has used this product as well. What you are forgetting is that scaled production of the product was shut down when they started the move of production operations to the US in 2020. At that time, focus shifted from production to getting this to FDA for review.

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

The bull is in the chute! The latest PR has officially started the clock on i dotting and t crossing before submission. If this takes any longer than a few weeks . . . max . . . investors are going to start questioning leadership as to why they are sitting on their hands. Be on the look out for another PR or an entry in the PMA database. Then, the chute opens!

Speculation creates two types of people . . . geniuses and idiots. The vast majority of posts seem to be negative speculation. This is not helpful to anyone who is new to this company and may want to invest (either bull or bear investors). So back to the facts.

14 weeks ago a PR was released stating all testing was complete EXCEPT sterilization testing. The company has restarted discussions with the FDA in anticipation of receiving test results and subsequent submittal to the FDA. Rewind the clock a few years, and the entire manufacturing process was moved to the US. The last step in this multi-year journey is the sterilization testing.

This is all we can know factually at this time, because this is all the company has released.

Now let the speculators have their fun. They will tell you I'm wrong, I'm crazy, etc. All I have done is summarized the FACTS.

If you want to speculate - and use logic while doing so - the team would not have have publicly stated they have re-engaged with the FDA if they felt that the sterilization testing was going to take long, or would fail. Publicly providing misinformation to shareholders is fraud - illegal. Just ask Elizabeth Holmes. Speculating - they must believe they are close to the milestone of being able to submit to the FDA.

Will this lead to FDA approval? Who knows. Will this lead to $1, $5, more? Who knows. All we can do is use the information that has been provided us, and speculate that the company is as close as they have ever been. Only time will tell.

Maybe 2024 is our year! Maybe 2024 is just like the past several years - time will tell.

Not sure if it's comical or disappointing to see the amount of disinformation being spread simply because people are not willing to spend a bit of time doing research. Yes, they made bandages. They were available at Walmart in 2019 (If you don't want to believe this link, you can also check their FB post form 2019 announcing back in stock. It didn't require attending a private shareholder meeting, or friends in high places to find this. Just a few minutes of research. https://www.walmart.com/ip/BooBoo-Strips-Hemostatic-Bandages/350184890?fbclid=IwAR2fDlQuqH8qmGHgAdy0iD5DZZ9tIE63YodtLu3Qba1YHkGCbBQBOUovTjA

That being said, it's still no excuse for the current situation. What anyone outside of the company or test facility knows is that the wait continues for tests to be completed, data to be documented, and hopefully a submission to the FDA for review.

11 weeks is MORE THAN ENOUGH TIME to complete those tests. From the companies I've run, and my experience, If I was Thom, I would be sleeping at the test facility, right next to the testing team and the owners working daily to get this done well, ASAP.

I get "wait and see for shareholders." The wait and see by Thom while the test facility F#*^S around is INEXCUSABLE. Take some ownership and walk the test facility across the finish line.