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The data I just posted is from the FDA.GOV website. You are a jerk as usual. Go back to bed and come back in 6 months when all will be approved and deals in the making. From here on out, you’re ignored and blocked.
Right you are trust. A quick search of 510k medical device approval time gave this explanation:
“How long does it take for the FDA to approve a medical device?
According to the FDA, the typical timeframe for FDA 510(k) approval is 90 days. Applicants can expect an acceptance review decision within 15 days and a substantive review decision in about 60 days. A final decision usually comes within 90 days. If there are review issues, the applicant is notified within 100 days.Oct 19, 2022”
Thanks Jimmy.
Yes, that’s true but it doesn’t take into consideration the new eStar submission platform. So, I did some investigating of eStar and my impression is that eStar is a comprehensive submission platform that doesn’t allow the submitting company to be less than complete with everything that is needed in order to fulfill the requirements for approval.
After going through a dozen presentations of eStar, I feel that the submission will get a quick turnaround on the necessary info needed to green light the full review. My expectation of approval, if it’s coming …and, I personally think so, is mid to late May …or sooner. I really don’t think the decision from the FDA will go beyond 3 months from 3/21. That’s my educated guess.GLTA!
Hey MORON, we have a full clinical submission on 3/20/24. You post nothing but BullShit!
You ass! That statement is what EVERY company has to put in their pressers when going for an approval. Just standard legal jargon! God you’re an idiot!
Means NOTHING…. We have a FULL FDA SUBMISSION!
Go ahead, try and pick that apart, douchie!
1. Brian Thom is a M&A executive who was with Societe’ General.
2. He maintains his broker license but is not an active broker.
3. He is fulfilling all contractual agreements as CEO of UHP.
You twist the truth to your narratives which shows what a dirtbag you are.
You are a liar and a FRAUD!
Idiot!
There are NO outstanding suits against the company! Period!
I’m no con man, you are doing what you always do which is PROJECTION! I’m an informed investor. You see dirtbag, I was in the business for 36 years and retired in an executive position from a 17 billion dollar pharmaceutical company. I know what it takes, by just reading a clinical study, to know if it has any potential for FDA approval and, this product will get approved! It was “my business” to know this! I do not work for the company, categorically, and I never have.
You on the other hand, try to create confusion with posts that are clearly old news or by using misleading content to “twist” the narrative to create unfounded fear in the legitimacy of this story. You try to get investors to sell so that you, the SHORT SELLER” can make money.
The very fact that you can try and disenfranchise investors with a positive like the full FDA submission is telling in and of itself. You are not legitimate and what you do-is an abject lie, a failure and totally fraudulent!
The people that remain on this board are longs that have been here from the beginning and you will never have any effect on them you’re totally misleading to regular investors in this stock.
You are the worst that humanity has to offer when it comes to honesty, integrity and character!
Sounds great! Molto bene!
Hey Band Aid, can I carry your bags in Italy?
Man, you crack me up! Do you get paid by the post or by the word. What a miserable life you’ve picked for yourself. While you’re spewing your lies I’m buying!
Hand over fist!
OLD NEWS, DUMMY! That’s been settled back in ‘22. Clean slate now!!!! What an absolute idiot you are!
Hey Chris, lately I’ve been fed up with the lies from “shoonshortseller”. I’ve been dumping on him and am gonna just ignore…for now. BTW, I’ve been adding to my position and accumulating even more shares and enjoying every buy!
Old news douchebag. 2019!!!!!!!!!!
Don’t even bother with that POS!
You’re a despicable piece of garbage!
Old news…..douche bag! Nice try, back to your basement.
Well, the wind is blowing his way so, either way he needs a change of clothing…lol. You can always tell when they’re paid hacks.
I see you’re still pissing in the wind. I’ve wondered how much you’re making as a “paid hack” for the market makers. It shows your character is an abomination!
You’re done here, asshole!
Good compilation of the product, Rodman. I went back and read the peer review from the Journal of Wound Care and their conclusion is definitive. Shareholders should be encouraged by this which I copied and am posting here:
“Conclusion
Taken together, the findings of this study showed that the NORC was more effective in controlling low to moderate bleeding that occurs during abdominal, thoracic, and vascular surgeries. The NORC was able to control bleeding within two minutes of application in all cases. Given the other characteristics of the NORC, such as a neutral pH, bacteriostatic and bioabsorbable properties, it should be considered for use as an adjuvant to control bleeding during open surgeries.”
I’ve been around since your time frame as well. I’m a retired PHARMA executive of 36 years and after all I’ve seen and experienced, I would stick around a little longer. They’re about to submit any day now. We have the goods, a completed prospective trial and a stellar peer review from the world’s most prestigious wound care journal.
Management has made mistakes and COVID slowed everything down but I’m feeling more positive about our prospects than ever before. Sit tight, don’t listen to the paid bashers and watch everything unfold. We are close.
DR5
Thanks trust for relaying what we all feel about these hacks. They know squat and it shows.
Yes sir!
The hell with the market not giving you the appropriate response. Just wait and see. Everything you need to know was in the presser.
Confirmation of submission should come next week.
Same to you, brother!
I wouldn’t be surprised if the company filed a defamation suit against him.
Chris, I don’t see a specific time frame from the last presser. It said that they are awaiting final reports on sterilization and bio-burden testing. Again, it seems like we are waiting for a third party to complete their work. I’m hoping we hear something in the next couple of weeks.
Spot on Dark2.
Hey Dark2, I’m not subscribed to the pm’s anymore. I’m looking for 10+.
Right you are, Roddy. It also shows the character of these dolts and that speaks volumes.
I’m not wasting my time with those 2 ignorant posters anymore. I just wanted to share correct information so that the people who follow my posts are not distracted by the idiocy of their posts.
I want to relay to all of my “long” friends that I’m still buying and expect that we will get the gratifying press release that everything has been submitted.
I really don’t think that the FDA would have picked our company out of all the other companies to pilot the first submission using eStar unless they planned to approve HemoStyp. I’m more encouraged now than ever before and wish the best to all long’s.
You dumb shit….what do you think was reviewed? THE CLINICAL TRIAL YOU MORON!
I’m not wasting anymore of my time interacting with an ignorant POS like you!