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OTC short report bud. If youre not using it for OTC stocks youre not a micro-cap investor worth your salt. Google OTC short history, then type in TLTFF .... it's pretty easy and very important when playing at the casino
HEAVY shorting here in the US. Can anyone explain why there is so much shorting of this on the TLTFF trade?
Watched the videos from Belgium. So excellent, so good and according to global key opinion leaders we probably don't really need any randomized control trials to prove just how good these beads really are! This is so exciting and a great bonus for all CTSO holders. Hardly any money needed, just more sales and more positive videos and stories from the docs! Kevin was wrong, CTSO could thrive and change medicine without any scientific RCT backing...so cool ! So 2019! Yes lost quite a bit on TTOO but now will roll back into CTSO and ride the wave that changes critical care medicine forever!!!!!!!!!!!!!
Dreams of $80 to $100 seem to be fading fast. Be careful with the "approvals all over the world" comment, remember that CE approval is primarily safety based. When you are always used as an adjunctive therapy the real efficacy remains buried. In order to get a true picture of the power of the beads, we'll need some RCT data with a control arm to truly gauge the effectiveness. I will formulate a RCT strategy with my Nephrologist friend and send the details to the company for their reflection. I for one would look to get back in this gem once I see a double blinded RCT with 28 day mortality as a primary endpoint. Not to be rude, many of you don't seem to understand the RCT process at all...I too was naive until our family nephrologist friend Kevin educated me on the entire FDA process...quite enlightening indeed!
Share price not the fault of the leader. In medicine, nothing becomes mainstream or SOC ( standard of care ) until considerable work is done in the area of randomized control trials. The only RCT for this company that addressed the holy grail ( sepsis ) was the German trial and from what I've read it failed miserably. Please provide proof if I am incorrect. My understanding is that far more people died in the Cytosorb group, but there was a claim that we treated the sicker population. Not sure how they happened given it was a RCT ??
So many off label uses...but virtually no randomized control trial ( RCT ) proof of any "on label" efficacy....important not to get too far out over your skis...too much traversing here and not nearly enough hard-packed snow proof of efficacy.
Usually trials are required for standard of care, of course American Standard is always on the table...I'd be flush with that.
Great post and thanks for the vine. Why not develop an assay to measure cytokine levels and other important toxins that the beads are known to remove or reduce. We would call this an accompanying diagnostic and the addition of the measuring stick would turn the filter into a theragnostic therapy. Much easier to measure efficacy and know when to initiate, when to continue and when to terminate treatment. This form of personalized medicine is really becoming more the norm in critical care medicine every day. This from my nephrologist friend.
FMC sales effort. Was wondering what data point or efficacy from a true randomized control trial that Fresenius has at their disposal to sell the filter system? FMC is a lot more astute at the medical device game than say Waljeans.
Sincerely,
E Holmes
Interim efficacy and safety report. The primary endpoint is AKI or acute kidney disease, this is far from black and white. I don't think we see much on efficacy for quite some time. The timelines announced and promoted here are ridiculous and verging on laughable. Just like the fact Hemodefend was said to be approved for 2019. Get a grip peeps!
Direct sales? Thought Fresenius was a partner? Why isn't Fresenius selling the beads? My guess is that they need more RCTs or hard data to back efficacy, FMC won't swish, swill and swallow the AndayCap case study circuit. Nuff said
Hemodefend is proven - 20 years old. I'll bet it is being used all over the world except for right here in the good ole USA. I'm waiting for it's approval and then I'll ante up again after EDTXF get their approval for Toraymixin!
Hemodefend is supposed to be approved this year, not enrolling this year. I think Hemodefend has a 20 year history so approval likely a snap. More competitor advancement after hours with TTOO and another FDA break through release! First, AEMD, then EDTXF with registered FDA phase IV and now TTOO, looks like we're next, heres hoping anyway!
CTSO is 40 cents, they just consolidated it. Do you understand a share price consolidation? It allows for a much wider audience. Some speculate Spectrel prefer not to have an audience. Can you think of why that might be?
Loving the move today! Don't know if it is related to ebola, bilirubin, cancer, norwalk, sepsis, Hemodefend, drugsorb, Sorb XL or the fancy tie that Dr. Chan is wearing today. All I know is that this is like owning a grand buffet of medical device stocks all in one tidy package!!!! Long the CTSO story!!!!!!!! Wowzers!
Response to CTSO poster
It's Toray of Japan that will be devastated Professor. The brilliant Sorb XL product will be Spectral's best friend. You see Toray manufactures the PMX column and has only given the rights to Spectral in exchange for the FDA stamp of approval. Spectral is in prime position to pounce and make a whack of bread off the sure to be blockbuster Sorb XL. Spectral already has the EAA, an FDA approved diagnostic to measure endotoxin and the state of the art and FDA approved CRRT machine to deliver the magical beads at bed side. Spectral's ingenuity will allow the XL filter to dominate the globe and instantly give it "theranostic" powers that will catapult the XL to the top of the sales charts. As you can see, I'm wildly excited about the Sorb XL and am anxiously awaiting it's first human usage so that Spectral can partner up with CTSO and make Endotoxemic Septic Shock a thing of the past. I just feel sorry for Toray and their 50,000 employees, sure they will continue on, but PMX might be absorbed by the spongy success of the Sorb XL. Fortunately Toray owns about 46 MILLION shares of Spectral, so they will at least benefit from the sales of the EAA and the CRRT machine that will help make the Sorb XL great and EDTXF shareholders a heck of a whack of money! Great post Professor, I like your advanced thinking! Remember too that there is talk of the Hemodefend being FDA'd in like 20 patients, wouldn't surprise me of the Sorb XL only required a similar amount! Dare to dream, look what jack grew from his magical beads!
It's Toray of Japan that will be devastated Professor. The brilliant Sorb XL product will be Spectral's best friend. You see Toray manufactures the PMX column and has only given the rights to Spectral in exchange for the FDA stamp of approval. Spectral is in prime position to pounce and make a whack of bread off the sure to be blockbuster Sorb XL. Spectral already has the EAA, an FDA approved diagnostic to measure endotoxin and the state of the art and FDA approved CRRT machine to deliver the magical beads at bed side. Spectral's ingenuity will allow the XL filter to dominate the globe and instantly give it "theranostic" powers that will catapult the XL to the top of the sales charts. As you can see, I'm wildly excited about the Sorb XL and am anxiously awaiting it's first human usage so that Spectral can partner up with CTSO and make Endotoxemic Septic Shock a thing of the past. I just feel sorry for Toray and their 50,000 employees, sure they will continue on, but PMX might be absorbed by the spongy success of the Sorb XL. Fortunately Toray owns about 46 MILLION shares of Spectral, so they will at least benefit from the sales of the EAA and the CRRT machine that will help make the Sorb XL great and EDTXF shareholders a heck of a whack of money! Great post Professor, I like your advanced thinking! Remember too that there is talk of the Hemdofend being FDA'd in like 20 patients, wouldn't surprise me of the Sorb XL only required a similar amount! Dare to dream, look what jack grew from his magical beads!
Super news! three IR contacts! This could touch $8 today. Making money on my average down tranche. Looks strong to very strong!
Excellent marketing piece Bertha48. Seems like most every health related crisis that makes global news is treatable with the beads! That is why I own the beads, it is the most versatile, useful therapeutic device on planet earth! It is no wonder that posters here speak of $80 and $100 in the future. For me, and the nephrologist, we would like more scientific backing in the form of RCTs as we believe this would advance our cause far more rapidly.
The Ebola bump was on AEMD. AEMD is the leader in this space. AEMD now has FDA FASTRACK. I like AEMD as my second favorite filtration play. I place CTSO first, AEMD second and give the bronze to EDTXF. Anyone else own the trio?
Was that last post 5 years old?
Thanks Berta. The filtration space is getting hot and CTSO is the clear leader with over 20 MILLION in rev. AEMD has an FDA fastrack and Spectrel Medical is waiting on a final response from the FDA. They submitted their final docs on January 16th and are waiting for i dotting and t crossing. I like EDTXF because it is laughably cheap! Paremeters for their phase IV add-on trial should drive a couple pennies of value over the short term.
FDA and "rest of world" very different animals fellas. The rest of world or CE mark is safety based. The FDA will want their device cake and the ability to consume it's efficacy as well. I know we apparently treated the more difficult group during our German Sepsis Trial, however our results on the efficacy side were alarmingly low. I have read that because we treated many that were on dialysis, we achieved a negative 17% efficacy over the standard of care. Please correct me if I'm wrong.
Why does cardiac sound like an afterthought? I listen to our CEO and each and every opportunity. He always mentions Sepsis first when discussing market opportunities for our Brita Filter for blood product. At the very end of his listing he always says, "and in high risk cardiac surgery". In my opinion as an observant shareholder, I think we should have high risk cardiac surgery as our lead story. Given REFRESH and now REFRESH 2 are the most important and only real FDA RCTs we've run, cardiac must be listed first. Just a thought from a valued holder of CTSO. More needs to be added here, so NOT nuff said at this point.
I am not the smart one. It is my father in-laws nephrologist that has provided me the foundation to understand the hemoperfusion space better than any individual non-doc that I know. I understand RCTs and the power of precision medicine. At these levels CTSO starts to get attractive, but I will hold off on the purchase of further stock. I have been shopping the big pharmas as of late as I just got a raise of nearly $4,000 per year. I have also added to my EDTXF holdings as I maintain their science is second to none. Best to all the gang here!
I think Pearsy was the intentional moniker that was so obvious it made peoples believe it was so good he just had to bash or beat down the stock price. I would bet my boots that Pearsy never once commented on the lack of scientific backing. Constant management messages are along the same lines. We know management can be changed but not so much the product. Let us just get the 28 day mortality part of the equation sorted and we can move on towards the lofty shared stock price prognostications!
CURE for Sepsis? Strong statement for a company running a trial in hopes of gaining an FDA for a condition that has NOTHING to do with Sepsis. More importantly, the trial has NOTHING to do with 28 day mortality. Neither the primary or the secondary endpoints of the REFRESH Trial are targeting 28 day mortality. Critical care medicine is ALL about 28 day mortality. Suggesting they have a CURE for Sepsis is a real headscratcher given their approval process is all about AKI or acute kidney injury. Sepsis is mentioned nearly as often as Fresenius, although trial data and proof of Sepsis efficacy is very much lacking. Telling readers they have a CURE for Sepsis is a bit of a stretch.
Fresenius; what data backs their sales? What science do they promote? AndyCap's weekly case studies? In fairness to Frensy, they need RCT data and STAT, in order to move filters. FWIW
Amen to that Hadtosayit! Likely why we are off 5% on this exceptional news day! NUFF said!
EDTXF is partnered with Fresenius as well. But Shhhhhh! don't tell anybody, it raises the price of the raises. ALWAYS buy what you're NOT being sold...well almost always. GL and congrats to CTSO longs, a wonderful day in Joysy!
Why "and in cardiac surgery" as an after-thought if this is where our FDA trial is being run? I listen to Chan religiously and he always throws the cardiac part in at the end like it is "with fries" I don't get why our most important REFRESH trail is not front and center! Come on man, let's get excited about cardiac therapy as our primary thrust!
Thanks Had. I think it's just EDTXF or EDT on its main exchange in Toronto. It is amazing how much scientific data this company has accumulated. A very detailed double blinded phase 3 FDA trial with a sham filter too. It looks like they have a really good chance to achieve success. They bring a theragnostic approach by combining a diagnostic and a filter. They also have a state of the art plug and play pump to deliver their filtration system. I won't sell my last tranche of CTSO, but I do like the EDTXF opportunity. they have 3 parts to their puzzle with 2 pieces FDA approved and the third in the final stages with a compassionate care approval already achieved on the final piece...the PMX filter. I'm kind of surprised nobody here is aware of this company to any degree.
BYE BYE? Really? 150 patients to a Sepsis approval here in the US? Are you guys part of this game?
BIG news in filtration space this morning. EDTXF has received FDA clearance to finish their phase 3 FDA trial using existing patients and adding on 150 patients here in the US. 100 will get their PXM treatment and only 50 the standard of care or SOC. Using the favorable Bayesian stat platform, a treatment for Sepsis here in the US appears very close at hand! Great news for CTSO, AEMD and EDTXF as well. Good luck to all!
I find it strange that NOBODY knows anything about Hemo
How long has Hemodefend been in their stable? Given the confidence of a 2019 approval, has there been a lot of human trials on this unique, promising device?
Dr. Chan is great..NO doubt, BUT.......we don't change the process of blood transfusion here in the United States based on a 20 person study...not worthy of the word trial when talking about 20 people. Reality seems to have temporarily escaped the core group of supporters this morning.
REFRESH II has nothing to do with mortality, not even the secondary endpoint. The real important data is all about AKI. The effects on the kidneys will take much time and analysis. I believe the one year data on REFRESH II is the key data. With all the admin and back and forth, I believe meaningful data on REFRESH II starts trickling in around Q2 2020. This is just the nature of FDA trial work....you must remain committed and patient in order to realize full value. Best of luck to all!
They are efficient. Hemodefend revenue by end of this year with no trial commenced as of yet. This is impressive Biotech....VERY impressive!
How long has Hemodefend been in their stable? Why hasn't it been moved along sooner? Will it surpass Cytosorb revenue? If so, this stock is under priced in my opinion. Appreciate the timeline on Hemo!