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Yes there is…I’m not gonna help you one bit POS. You keep believing that…you’ll never make any money because you’re stupid.
Lying POS. There is a clinical trial and it was a direct comparison with SurgiCel and they were far superior you numbskull. Why don’t you go suck some car exhaust. Lousy POS!
I second that and will be adding to my position.
I’d pay money to see that…lol.
You don’t have a leg to stand on………scum!
I’m hanging in. I’m focusing on the clinical trial and the peer review. There’s nothing and I mean nothing that the doomsday posters can say to discount or discredit that fact. I’m waiting this out…plain and simple.
They are incapable.
Presser update. Delays with the packaging vendor but no bad news. Long and strong!
https://finance.yahoo.com/news/united-health-products-reports-product-122900842.html
There was you dumb shit. Go look it up, troll!
Right you are ,Trust! Most of my work life was PHARMA. I will also reiterate that if you have a positive, we’ll controlled, multi-center trial that gets a stellar review from the “most respected Wound Care company in the world”….that’s the equivalent of the “HOLY GRAIL” in terms of weight towards FDA approval.
That’s why I’m hanging on to every share of my stock!
I identified that early on and reported it but, as usual, it fell on deaf ears.
Absolutely, I was looking at the L2 quotes from CDEL and they had the ask at $1.25 for a lot of the day. This will continue until we get some positive news.
Yeah Jimmy, the market makers having a field day with the stock price. Can wait for the next presser to force them to move the ask higher.
With you and Trust. This will finally happen. June 7 presser reiterated end of June target for completion of items related to submission. Seems like we’re almost there.
I saw it on Yahoo finance. It’s there.
Absolutely, it shows that Thom is sticking to previous guidance and that the re-testing on product was successful. I think it’s positive news.
Right you are lonetree!
Hang in bro.
Chris, we don’t know what we don’t know. I mean there are many moving parts and we’re not privy to these. What I do to keep focused is to believe in what we have(and I do) and leave the rest up to Thom and the team. When approved this product will grab the lion’s share of the hemostat market. Competition knows that and we will all benefit…….except the shorts who will get squashed. We’ve come this far….we can go a little further. Keep the faith!
There seemed to be questions regarding whether the company has undergone additional testing to prove out product. Here is a press release dated 3/29/23 that will answer any questions:
“In light of these anomalies a second round of testing for manufacturing consistency is underway. The company has produced new batch lots which have been delivered directly to the lab where samples will be taken in a more controlled environment. These samples will then undergo the required tests to confirm the uniformity and consistency of the company’s manufacturing process. In parallel with this effort, preparation for packaged product testing by the company’s packaging partner will continue, providing necessary confirmation of packaging integrity, effective sterilization and other criteria.”
Since you don’t know if the product they are re-testing has met expectations necessary for us to move forward with a submission, you or anyone cannot make an arbitrary decision on what will or will not be accepted.
If RCA and the company deems the product is “nearly identical” and submits the application then your concerns are moot.
What is the success rate of FDA PMA?
“In the five years preceding the changes, FDA approved 70% of PMAs that were sent for review by a panel of experts. After the changes, the approval rate shot up to 92%. The analysis showed that devices are typically approved if the panel votes in favor of their safety and benefit-to-risk ratio.Jul 12, 2019”
Discussion:
As quoted from a search, approvals for PMA CLASS 3 medical devices have gone up to 92% in recent years.
The approval criteria, for the large part, centers on “safety and benefit-to-risk ratio”.
HemoStyp is “all natural” and safe with no side effects and interactions as stated by the company so, it would seem that based on these criterion HemoStyp would have an excellent chance for approval, IMO
Correct Rodman, he has a lot to lose and 30 million reasons to hope for a good outcome. It’s been stated here before that well over 90% of med-surg products are approved “if” the FDA accepts the final submission for PMA approval. If we can get to that point the odds are in our favor.
Agreed band aid. They are on the hot seat to perform. They have till EOM to get the submission done.
Ok, let me elaborate. I didn’t mean 7-8 years for approval. I meant that from the start of the process going all the way back to the beginning, even before they started the clinical study.
You might consider that, generally speaking, it takes an average of 7 to 8 years to get a drug through the FDA. That’s speaking from experience.
That’s right Rodman, baseless opinions that are worthless!
Chris, his number is bs.
Chris, we do have any idea what the final result will be but I feel very sure it will not be $2.
You got that right! Yeah, I’ve been in this stock since ‘16 for $2/share. How ridiculous is that?
Congrats!
Don’t know if you’ve sold yet but I would give the company till the end of June to make good on their last presser. You have to remember that we have a positive, peer reviewed clinical study on HemoStyp. That’s worth money to somebody.
Solid team. I don’t think we’ve come this far to not receive approval. IMO, the company would have known long ago if the FDA would reject the product.
Hi Band Aid, my opinion is we stay positive. Don’t let the negative stuff phase you. We will hear something from the company very soon IMO. Remember, the current price has nothing to do with the final outcome we’re all looking for. Keep the faith.
Thank you for exposing the bogus post.
Read the filings closer…..that was in December. The other filing showed he just bought 225k shares on the open market on 1/17/23. That’s very encouraging!
Hey band aid, I’m just an observer these days. I keep out of the “…” show. I’m still sitting on a big position. We just gotta wait this out. It will happen but your guess is as good as anyone when. I keep focused on the what the data showed and someone is gonna pay for what we have.
DR5