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Sole69
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....Präsentation vom CEO und der Kurs taucht 10%, sind nicht gerade good news:-) ?

Sole69
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Also wenn die Zahlen gut sind, wäre das eine RIESEN ÜBERRASCHUNG!!!!

Wieder einmal von 11.60 runter auf 10.11 in 5 Tagen, unglaublich.....

Hans
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Nene, vor den letzten Q-Zahlen lag der Kurs bei $7, die Longs sind seither die Gewinner, die Shorties die Verlierer .. und am Dienstag kommen wieder Zahlen .....

Gute Zahlen, keine Frage denn schliesslich wirbelt seit 3 Monaten ein Verkaufsmannschaft!

Gruss Hans

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Bei guten Zahlen würde der Kurs anderst reagieren? bist du zufrieden mit den Zahlen?


Gruss


Sole

Hans
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Die präsentierten Zahlen sind erwartet worden,  dh dies wurde bereits vom CEO in Aussicht gestellt, kommt Cartiform und Prochymal in die Gänge dann geht die Post ab ... Jedenfalls bleibe ich dabei, falls Aktie noch unter $9 gedumpt wird kann man noch günstigst aufstocken ...

Was etwas erstaunt ist dass Prochymal brach liegt, keine Umsätze bisher, sind die zu blöd das zu vermarkten?

Gruss Hans

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We have made Prochymal by far the most widely used stem cell drug in the world Lol

Zulassung seit 1 Jahr in Kanada und Neuseeland = 0 Einnahmen. Respekt, wie ist das mit der obgenannten Aussage des CEO vereinbar? Da ist doch was faul! Der überbewertete Kurs kommt noch glimpflich davon. Die Investoren haben sicher Verständnis :new_russian:

Sole69
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Das verstehe ich auch nicht, wie das mit 0 Einnahmen geht obwohl sie eine Zulassung haben.

Langsam aber sicher werde ich diese Aktie verkaufen......

Sole69
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und nach den zahlen erhöt ein broker von 11.50 auf 14.00

 

verstehe ich auch nicht....

 

http://finance.yahoo.com/news/osiris-therapeutics-price-target-raised-18...

Hans
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$14 als Kursziel auf 12 Monate ist viel zu tief, da werden sich noch welche wundern...

Gruss Hans

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Partner für Prochymal wird gemäss CC  von heute gesucht, das dauert noch Wochen oder auch Monate, dann geht die Reise los...

Zudem: Osiris erhielt 2008-2010 total $138 Mio für Prochymal, für deren Entwicklung und diverse Kontrakte mit div. Firmen, das ist Geschichte.

1 Dose Prochymal soll wie heute im CC erwähnt ca. $20K kosten...

Gruss Hans

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gollum hat am 07.05.2013 - 20:51 folgendes geschrieben:

We have made Prochymal by far the most widely used stem cell drug in the world

Zulassung seit 1 Jahr in Kanada und Neuseeland = 0 Einnahmen. Respekt, wie ist das mit der obgenannten Aussage des CEO vereinbar? Da ist doch was faul! Der überbewertete Kurs kommt noch glimpflich davon. Die Investoren haben sicher Verständnis 

An der Börse wird die Zukunft gehandelt! ...wart's ab ... Aber Zocker wollen ja bekanntlich nicht warten, hehe

Gruss Hans

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Hans, selbst mit Zukunftsphantasien ist OSIR doch fundamental krass übebewertet?! Wenn das Zeugs schon einzigartig ist, wieso kann man denn nix davon an die Frau/denn Mann bringen.... Zocker sind wir doch alle, nur der Horizont ist unterschiedlich Wink

Hans
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Blockbuster ... aufgepasst, Osiris wird schon erwähnt .. noch nicht im WSJ ... das kommt noch

http://www.fool.com/investing/general/2013/05/08/is-the-golden-age-of-blockbusters-over.aspx

Gruss Hans

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Aufgepasst auf was, auf den üblichen sturzflug unter die USD 10.00???? das ist ja mega langweilig.....

Hans
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Investition in die Zukunft der regenerativen Medizin

Interessanter, brandaktueller Artikel zum obigen Thema, u.a. zu Osiris "on the leading edge"....

http://resilience-economics.com/2013/05/21/investing-in-the-future-of-re...

Gruss Hans

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gollum hat am 08.05.2013 - 14:30 folgendes geschrieben:

Hans, selbst mit Zukunftsphantasien ist OSIR doch fundamental krass übebewertet?! Wenn das Zeugs schon einzigartig ist, wieso kann man denn nix davon an die Frau/denn Mann bringen....

Ich denke nicht dass Osiris krass überbewertet ist, studiert man den ersten Beitrag in diesem Thread, so sieht man das Potenzial, zudem ist dort nicht mal alles aufgeführt ... Und einige Produkte generieren schon schöne Umsätze, kommt dazu dass bei diesem Wert nicht wie bei anderen Firmen Aktien en masse auf den Markt geworfen werden ... Und, und, und ... Füsse still halten!

Gruss Hans

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Dies sind die zukünftigen Erwartungen

http://finance.yahoo.com/q/ae?s=OSIR+Analyst+Estimates

 

Gruss Hans

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News, heute

Osiris Therapeutics, Inc. (OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that C. Randal Mills, Ph.D., President and Chief Executive Officer, is scheduled to present at the Jefferies 2013 Global Healthcare Conference on Monday, June 3, 2013 at 4:00 p.m. ET in New York City. 

Gruss Hans

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Das sieht nicht nach guten news aus!? 4% minus

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Hallo Hans, weiss man etwas von dieser Presentation? Die war doch gestern?

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Sole69 hat am 04.06.2013 - 20:32 folgendes geschrieben:

Hallo Hans, weiss man etwas von dieser Presentation? Die war doch gestern?

Ja, hat stattgefunden .... dort wurde Altbekanntes* vorgetragen, natürlich wie immer im besten Licht ... Prochymal Deal lässt auf sich warten ... scheint so wie wenn dies in den Hintergrund tritt und andere Produkte wie Cartiform vorerst in die Bresche springen werden ... mal 2 Quartale abwarten was die Verkaufscrew reissen kann mit Grafix und Ovation (Wundheilung - in 1 Quartal $4 Mio, Gewinn 2,9 Mio) da werden sie der Konkurrenz einheizen 

*) Randy liess sich nicht in die Karten schauen, denn es geht um sehr viel Kohle 

Kursziel, vielleicht $14 auf 12 Monate

Gruss Hans

Hans
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Heute ging ein Block von 177K über den "Ladentisch"

Dirol

Gruss Hans

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also weit und breit keine Aenderung und wie gesagt bin seit 7 jahren dabei.

Und mit deiner Aussage mit einem Kursziel von USD 14.00, zeigt mir, dass du auch nicht mehr so positiv bist.

Hans
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...ist man zu optimistisch zieht es nur zu viele Fliegen an Wink

Damalige Einschätzung, oben:

Prochymal for Graft vs Host Disease (GvHD)........$200 Mio

Dies ist zu revidieren da eine Behandlung nicht 10K sondern 20K kostet gemäss Aussage von Randy im Jan 2013 ... gesamthaft ist das Marktpotential weltweit gegen 1 Mrd USD .... nur für dieses Produkt!

Also jetzt warten wir mal auf weitere Zulassungen

PS: 1 Mrd Sales mit 70% Marge ergibt ~12$ Gewinn pro Aktie x PE 17 = 204$/Aktie ... wenn Osiris das ohne Big Pharma Partner stemmt, sonst halbiert sich das Kursziel

 

Gruss Hans

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Q2 2013 Earnings Call

August 05, 2013 9:00 am ET

Executives Charles Randal Mills - Chief Executive Officer, President and Director Philip R. Jacoby - Chief Financial Officer, Treasurer and Corporate Secretary Analysts Edward A. Tenthoff - Piper Jaffray Companies, Research Division Eun K. Yang - Jefferies LLC, Research Division Presentation Operator Good morning, everyone. Welcome to the Osiris Therapeutics Second Quarter 2013 Earnings Conference Call. Before we begin, I would like to remind everyone that this conference may include forward-looking statements that involve uncertainties and risks. Actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled Risk Factors in our filings with the Securities and Exchange Commission. As a reminder, today's call is being recorded. I would now like to turn the conference over to Dr. C. Randal Mills, President and CEO of Osiris Therapeutics. Please go ahead, sir. Charles Randal Mills Good morning, and welcome to our Second Quarter 2013 Earnings Call. Before we get started, I would like to remind everyone that if I do make forward-looking statements today, there are obviously risks associated with those forward-looking statements and to consult with the Risk Factors section with our filings with the Securities and Exchange Commission. Just to start off briefly. Osiris' has created a company that is the clear leader in cellular medicine, and we've done this through tremendous amount of hard work. For 20 years, we've been working within this space, learning about stem cells, how they interact and how they can help people going forward. We currently have 4 commercial products. We have 51 issued patents in the United States, and we have their foreign counterparts. We have 1,500 patients treated in clinical trials with over 2,000 years of patient follow-up, and we have treated over 100,000 patients commercially. And from a financial side, we're very proud that not only have we commercialized cell therapy products, but we've done it in a profitable way where we have set a gross margin of 72%. One of the things that we're working on at Osiris now that we've become a commercial company and have products out into the market is balancing our commercial and our R&D activities together. And I think the work and the progress we've made this quarter really highlight that. So from a financial standpoint, we're just thrilled that product revenue is up 231% this quarter, and that gross profit is up 245% this quarter as compared to the second quarter of 2012. Similarly, we're also very pleased that our diabetic foot ulcer trial, randomized, blind and controlled diabetic foot ulcer trial, is nearing completion of patient enrollment. We've also further expanded our commercial infrastructure, adding new salespeople to both our Grafix sales force and our Cartiform sales force. Recently, we've reported a 71% closure rate in difficult-to-treat venous leg ulcers. I'm going to be talking more about that coming up at the trial. And then lastly, in an effort to make sure that our pipeline is continually growing, we are preparing for the launch of Ovation OS, which is our advanced bone regeneration matrix specifically tailored for osteogenesis in difficult-to-fuse bone. Let's take a look really quick on the financial standpoint. We are very pleased to report that we've seen very strong sales growth. Sales this quarter came in at $5.3 million, up over 200% from the second quarter and up 30% from the first quarter of 2013. So we've continued excellent -- we have an excellent sales trajectory that we have continued through this quarter and we're very pleased with that. When we look a little bit deeper into our financial performance, you can see that progress is not just at the revenue line, but in gross profit continues to expand, $3.8 million compared to $1.1 million in the second quarter of 2012. And gross margin for the first quarter -- for the second quarter remained at 72% as compared to the first quarter, but is up 600 basis points from the second quarter of 2012. So in general, we're very pleased with the progress that we're making from a financial standpoint. We've made significant investments in our commercial infrastructure and that's been really paying off. Now I'm going to turn the call over to Phil, who is going to talk a little bit more about our financial performance for the quarter. Phil? Philip R. Jacoby Thanks, Randy. We did issue a press release earlier this morning that had our complete financial statements in them. As Randy mentioned, our revenue of product distribution in the second quarter of this year was about $5.3 million, which is 30% higher than the first quarter of this year and over 230% higher than it was in the second quarter of last year. We did experience revenue growth in all 3 of our Biosurgery products, which is nice. It was steady growth in the Grafix and Ovation products. Cartiform sales also increased, although they remained minimal in the second quarter of this year. Our direct sales force for Grafix is starting to gain traction. We're seeing steady growth in the opening of new accounts by -- for direct sales to end users, which is an excellent sign. Once you start selling to an end user, we've experienced very positive results and continued sales growth. As Randy mentioned, our gross margin remained at 72% throughout the first half of fiscal 2013. That was up almost 10% improvement in gross margin percentage over what we experienced in the second quarter of last year. We continue to operate our facilities using only a single shift. We have plenty of room for growth without making any substantial capital investments in our facilities. We're investing in our infrastructure to support the continued product and revenue growth, primarily in our IT systems and our customer support and billing personnel. Our balance sheet stays very strong. We haven't had any debt whatsoever since 2008. Our cash burn for the first half of fiscal 2013 was a little over $7 million, $3.8 million of which was invested in our Biosurgery receivables and inventory. Our receivables and inventory at the end of the second quarter was $8.1 million and that compares to $4.3 million at the end of fiscal 2012. Our bad debts remain negligible. The aging has been generally in pretty good shape, although we are focusing on trying to reduce the number of days sales outstanding. When we open new accounts, they tend to be slower payers initially, but they usually get on track within just a few months. On our R&D spending, there's $3.3 million in the second quarter this year compared to $4.1 million in the prior year. The Biosurgery R&D in the second quarter was about $900,000 and that compares to $1.2 million in the prior quarter -- on the second quarter of the prior year. The majority of the R&D in Biosurgery is dedicated to our diabetic foot ulcer trial, although we are continuing to invest in new product development. The Prochymal R&D was $2.4 million in the second quarter of this year and that compares to $2.9 million in the prior quarter -- or the prior year. Our SG&A spending was up overall, although our traditional G&A costs were slightly lower in the second quarter of this year when you compare it to the first quarter of this year, as well as the second quarter of last year. That's really the result of our continued focus on both cost containment and reduction. We are experiencing some intentional and very substantial increases in our selling and marketing costs related to our commercialization efforts. Our second quarter SG&A was $4.4 million in total compared to $1.4 million in the second quarter of fiscal 2012. The Biosurgery SG&A was about $3.5 million this year and that compares to about $400,000 in the second quarter of 2012. The increases in the sales and marketing costs for end-user sales and the development of our direct sales force should result in increased revenues in subsequent quarters. We ended up reporting a net loss of about $3.8 million in the second quarter of this year, and that compares to a net loss of $4.3 million in the second quarter of fiscal 2012. That equates to $0.11 per share during this quarter compared to $0.13 per share in the second quarter of the prior year. Randy, do you want to take it over? Charles Randal Mills Thank you. So as I mentioned on previous calls since we've gone over to this format of doing a presentation, that I promise that I would not go through an entire company presentation on every quarterly call because it's quite time consuming and you're busy people and have better things to do than listen to me rehash the entire company. And so I'm going to keep that promise today and go primarily -- I'm going to talk about 2 aspects of Grafix in the remaining moments. Before I do that, I do want to run around our current commercialized products and give you a brief update on each of these and what's going on. So with Prochymal, our world's -- the world's first approved stem cell drug that we're very proud of, we're making good progress on additional approvals for graft-versus-host disease. Notably, we are going through the approval and registration process in Switzerland, and we continue to make good progress on that in addition to other areas. We are also working to complete enrollment on the Crohn's trial, which continues. And while slower than expected, we are working diligently on that and making progress there as well. But our main focus with Prochymal really is to make sure we find the right partner for Prochymal. As you'll recall last year, we were able to regain full rights to Prochymal. And now that we have the asset back whole, we want to make sure we make the correct partnering decision and so we are making good progress there and that is our main focus with regards to Prochymal right now. But with regards to Grafix, this is our cellular membrane for the treatment of acute and chronic wounds, we continue to be very impressed with the clinical performance of this product. From a P&L standpoint, we have obviously made very significant efforts or investments in the commercial infrastructure here, and we're very pleased with the revenue growth we're seeing from those investments. I'm going to be talking more about Grafix on the remainder of the presentation, so I'm not going to dive too much into it now. Ovation is actually a very flexible product we have. We like it and the surgeons like it because it gives them a lot of options, to combine it with other products and use it on different wounds that need to be treated. We have an excellent sales team. We're using a distributor model with Ovation and we're very happy with that model, an excellent group of professionals that have been able to go out throughout the country and drive sales of Ovation. We're also -- and we'll talk -- I'm going to talk a little bit more about it at the end of the slide, preparing to launch Ovation OS, and Ovation OS is our product -- our version of Ovation that is specifically designed for the regeneration of bone tissue. Okay. And then lastly, Cartiform. This is our viable cartilage mesh that we use for acute articular cartilage injury. There's over 500,000 cartilage injuries each year in the United States that require surgery, and the vast majority of those surgeries fail. And so that's the specific need that we're trying to fill with Cartiform. What we're basically doing is creating a viable cartilage scaffold that's able to capture the patient's own mesenchymal stem cells and use them to ingraft the cartilage mesh from Cartiform. We now have patients that are approaching 1 year out in this unique surgery, this first-of-kind surgery, and all patients are doing exceptionally well. And so we're very pleased with the performance of Cartiform. We're very pleased with its applicability and its adoption that we're seeing. And because of that, we are investing also in developing commercial infrastructure and sales team here. So we look forward to good things to come with regards to Cartiform. Now let me turn to Grafix and spend a little bit time with Grafix because we alluded to some things in the press release and I want to take some time to go through 2 specific aspects. One of them is data that we have just released regarding Grafix, a smaller trial that we've done. And then the second one I want to go over is I want to give a very good and clear outline of the randomized, controlled trial that is currently underway and nearing completion with regards to Grafix. So first, let me start with an evaluation -- going over the data of an evaluation of Grafix that we did in the treatment of chronic wounds. So in this study, this was an open label, single center study where we were looking at Grafix to induce wound closure by 12 and 26 weeks as confirmed by image analysis. So in this study, we had 66 patients enrolled with a total of 67 wounds, 27 of those wounds were diabetic foot ulcers. But the interesting thing for us in this study was 34% of them were venous leg ulcers and I'm going talk more about why, but venous leg ulcers represent a very serious medical problem and a very large market opportunity for us in Grafix. So we're excited to evaluate Grafix against diabetic foot ulcers to see whether or not we can have a significant impact with this more difficult-to-treat wound type and potentially have access to a larger market. We also had 8 other wounds with generally things like surgical dehiscence and pressure ulcers. These were definitively refractory wounds, so 75% had failed advanced treatments prior to the application of Grafix. And the mean wound age, meaning these patients that had these wounds, for an average of 38 weeks. So these were very serious problems. Just give me an example of a venous leg ulcer and what a venous leg ulcer typically looks like and how difficult they can be to treat. Tech InvestorSeeking AlphaHere was a 69-year-old patient who had diabetes, obviously chronic venous insufficiency, was on dialysis and presented with a pretty large 43 square centimeter chronic VLU that was recalcitrant to a number of treatments. This is an example of that wound being treated with Grafix. You can see it was 10 weeks to closure, required 7 applications of Grafix. And so as I talk about the VLU arm in this trial to sort of keep -- this the patient demographic that we have to keep in mind. So how do we do with these results? So I'm showing the venous leg ulcer and the overall patients here. So at 12 weeks, we had about a 68% closure rate in VLU and a 76% closure rate overall. 68% closure rate in VLU is fantastic by 12 weeks. By 26, it went up to almost 71% compared to 81% in the overall. The great thing here that was the median time to closure was only 5.3 weeks in the VLU. So if these patients were going to close, they closed quickly and that we think represents a very real value proposition for the health care provider and the patient as well. Just looking at some capital and minor analysis of these closures, looking at the probability of wound closure. You can see again this is all patients in the trial with recalcitrant wounds. Again, that had been around for a median of 38 weeks before coming into this trial. We had an 80% closure -- probability of closure at 12 weeks through all 67 patients. When we look at how that worked on the venous leg ulcer, we can see actually a very similar curve and that's very encouraging, greater than 71% of probability of closure in these patients. So turning now to -- how the product was tolerated, the safety and durability because this is quite important here, too. So one, there were no adverse events that were attributed to Grafix during this evaluation. Two, there were no wound-related amputation. So these patients didn't need to go on and have any amputation as a result of their wounds not healing. And then the third bullet point is one that really gives us, particularly in the VLU setting, gives us great reason for optimism and that is, in this very difficult-to-treat wound population, we had no recurrence of these wounds through a 1-year follow-up. We're able to follow up 47 of these patients through at least 1 year with no recurrence of the index wound. So we're very, very pleased with that. Why? Well, the reason we're so pleased with this is because venous leg ulcer, VLUs, are a very significant unmet medical need in this country and throughout the world. From a pathology standpoint, if you're not familiar with VLUs, they result -- they arise as a result of congestion from the venous system. So basically, vascular insufficiency pulling your blood back to your heart away from, typically, obviously, your legs in VLU. That creates a vascular permeability. So in essence, these vascular beds in these patients start to leak. When that happens, that causes fiber and deposition, which results in hypoxia to these cells and these limbs don't get enough oxygen. And there's also a subsequent release of proteolytic enzymes and these enzymes that actually have the ability to break down the tissues in that area and lead to not only the underlying ulceration, but continue and prevent the healing of the ulcer ones it's formed. And so it's a very complex medical problem that requires a pretty sophisticated approach. And that sophistication of approach goes beyond just putting on a covering or a skin substitute because you, obviously, you have to deal with the angiogenesis here as well or the ability to create new blood vessels in this area. And that's one of the unique things we think that Grafix offers, is its angiogenic potential. The incidence, so there's over 70% to 90% of all wounds on the lower leg are that of VLU. In the United States, there's over 2.3 million people with venous leg ulcer, so this is a very significant potential market for us. 15% of those patients never heal and so it's a very significant issue for them as well. From a cost standpoint, this is one of our criteria and development for us to positively impact reimbursement, it's a $5 billion problem in the United States to take care of these VLUs and we're not even taking care of them very well for that much money. So when we look at this trial, what we're -- and the reason we're reporting this is because we see a very significant opportunity for Grafix to expand beyond the diabetic foot ulcer market into the venous leg ulcer market. And right now, what we're looking at is we're looking at conducting a trial similar to the one we have going on in the DFU space for -- so to support reimbursement in the venous leg ulcer setting. So look for more about that coming up. Now I'm going to talk as briefly as I can about Protocol 302. This is our ongoing trial that's evaluating the efficacy and safety of Grafix for the treatment of chronic diabetic foot ulcers. This is a multi-center controlled, randomized, single-blinded trial. It uses blinded imaging verification, so there's a core lab that evaluates the wound sizes and the closure rates. There's also an open label crossover arm, so patients that are randomized to control and those wounds don't heal, they're able to crossover and get Grafix and so we're able to see how many of those wounds we can bring back. The point of this is, this is a very high-quality trial in wound care that we think is really going to set the benchmark for the performance of an advanced would care product. And so I wanted to go over a little bit about this trial in more detail so you can have the specifics of it as we near patient -- the completion of patient enrollment in this trial. So let's just take a quick look at the objectives. When we set out to do this trial, what were we trying to sell? Well, the main goal is to support coverage by Medicare and private insurance. We wanted to demonstrate that Grafix offered a real serious value proposition. And when we say this, we mean basically 3 things: one, is that we can heal more patients with Grafix; two, that we can get these patients healed faster; and then lastly, because we can heal them faster, we would require fewer visits and fewer applications. Our overall goal here is to demonstrate that Grafix can actually reduce the overall health care cost to our system by providing our patients with better outcomes, and that's -- that is the main objective not only with Grafix, but with regards to this trial. Now when we look at the eligibility criteria, because this is a pretty big, serious trial, we look at our inclusion and exclusion criteria, go over just a couple of things to show you the types of patients we're bringing in. So these are patients between 18 and 80 years of age. They have to have confirmed diagnosis of either type 1 or type 2 diabetes since this is a diabetic foot ulcer trial. They have to have an ulcer defined as chronic. So the presence of the wound for more than 4 weeks, at least without healing, but not for more than 52 weeks. The ulcer, it has to be located in either the plantar or dorsal surface of the foot and will take sizes between 1 to 15 square centimeters. Patients are excluded, one, if they heal during the run-in period, and I'll talk about more -- I'll talk more about that in just a second; if the patient's blood glucose is beyond 450 milligrams per deciliter for noncompliance reasons; if the ulcer is of a nondiabetic pathophysiology. So for example, we are not evaluating diabetics to have them have a venous stasis ulcer in this trial; if gangrene is present at entrance to the trial; the patient is currently receiving dialysis; or if it's an uncontrolled diabetic with a hemoglobin A1c of greater than 12%. The way the trial is designed, it starts with the screening period. And so what we'll actually do is we provide these patients standard of care for 1 week, all patients prior to their randomization. And what we're looking for here is patients that are just going to respond with normal care. So if the patient has a reduction in wound size of 30% or more during the run-in period, then they're actually excluded from the trial because what we don't want is we don't want basically a lot of patients who, just with standard of care, are going to respond. We're looking at chronic wounds that don't respond to standard of care. If they passed that phase and their wounds are not significantly improving, then we randomize them into the blinded phase. Now here, patients are randomized 1:1. The patient is blinded here, so it's a single-blind trial. The patient is blinded. Obviously, the physician is not blinded because they had to apply the product or the control. So this patient either will receive Grafix or they'll receive the current standard of care, which is debridement of the wound, cleaning of the wound, wound dressings applied and offloading device applied. So it's an active control arm. The patients are followed up for 12 weeks in the treatment phase and so they'll come back to the center for up to 12 weeks, if they need additional applications of Grafix applied -- being applied once a week. If they heal, then they go into the follow-up phase. So all patients whose wounds close within the 12-week treatment phase move on to a follow-up phase. What we're looking for in the follow-up phase is for wound recurrence. So we'll follow these patients for an additional 3 months to see if these wounds open back up. The patients that don't heal during the treatment phase, if they're on the control arm, actually go into an open-label crossover. And so these patients are then provided Grafix for up to 12 weeks, 12 applications of Grafix once a week. And what we're looking for here is the ability to heal patients that were definitively refractory the initial 4 weeks, the 1-week run-in and then the 12 weeks of treatment, to see if we can heal those patients with Grafix after 12 applications. And so that's the basic design of the trial. The endpoints that we're looking for, primary endpoint is for a proportion of patients with complete wound closure of the index wound by 12 weeks, as defined by 100% re-epithelialization. Secondary endpoints center around time to initial wound closure. So not only can we close them by 12 weeks, but how faster we're closing them. The second one is really important from a pharmacoeconomic standpoint. We're looking at the number of applications of Grafix versus control dressings. And so if you have to use something else, how much of that other stuff you're using? And if you would've used Grafix, could we -- could it be significantly less? The proportion of patients who achieved 50% reduction or greater in wound size by 28 days, the velocity of wound closure is related to your ability to predict how -- what proportion of those patients ultimately go on and achieve complete closure. So that's where we're looking here in the third bullet point. The fourth bullet point, wound recurrence. We don't -- we wouldn't want to close a wound that would just immediately come back. So we're looking at the incidence of wound recurrence after the initial would healing. We want these patients' wounds to get fixed and we want them to go on and do well for a while. We think this is also a significant aspect from a pharmacoeconomic standpoint. If we can show payers that not only are these wounds healing, but they're staying healed and they're not going to continue to be a burden of the health care system, then we think that offers significant value. And then lastly, the wounds that we're able to heal that were randomized -- that were initially randomized to the control arm. So if we can show that patient's received standard of care can also be healed with applications of Grafix, we think that will really just show the power of the trial. Okay. A little bit about the statistics of Protocol 302. So the power was trialed -- the trial was powered to detect a 20% difference in healing rates, so our assumptions here were we would have a 50% healing rate with Grafix versus a 30% healing rate in controls. When you go back and you look at the serious randomized, controlled studies in this space, standard of care typically performs about 30% when you do a meta-analysis through those. And so that's why we picked 30% for the control arm because, again, the control is not a placebo. This is an active arm. These patients are actively being treated with standard of care. And we were perhaps concerned of giving some new data that came in with regards to Grafix. But ultimately, we'll see. What we're looking for here though mostly is at least a 20% absolute difference between the Grafix and the control groups. Now the protocol assumes a 30% dropout rate and so we thought we would have to go up initially to about 260 or so patients in this in order to get 186 of valuable patients. Today, I'm pleased to say though that the dropout rate is substantially less, down actually only around 15% in this trial. So it's much less than we thought. Patients are staying in the trial. They're being compliant. That's giving us a better look. That's also meaning we're probably not going to have to take enrollment up to 260 in this trial to complete it. Now I will say there is an interim analysis in this trial, so it's a typical interim analysis using a 2-sided O'Brien-Fleming method. It's planned, and the protocol had approximately 100 evaluable patients. So this is an enrollment of these patients, but 100 of the 186 actually have to have completed the trial. Once those patients come out, then they're considered evaluable. In this interim analysis, we have 4 potential outcomes: one is to continue as planned; one is to repower the trials. So if it was closed, but we needed a few more patients, we would repower the trial and continue the trial with adding more patients. We can obviously also stop the trial for fertility or stop the trial for overwhelming efficacy. Okay. So that just gives you an idea of what's going on with regards to Grafix. We have spent considerable resources building up our commercial infrastructure in Grafix, and we're very pleased with that. We are also, as you can see, spending significant resources working on the development side of Grafix, not only to demonstrate its utility in diabetic foot ulcer, but we're also looking into expanding into the venous leg ulcer market, which we think can perhaps double the market potential for this very promising product. Just again looking at our development rationale. With regards to the concepts, we've talked about these before, but it has to be a very real value proposition. It has to be a practical development pathway. As I said a number of times, it's not just enough to be the first in cell therapy, you have to also these days find a way to use the power that cell therapy provides you to ultimately reduce health care costs. We're looking to go into meaningfully sized markets. Obviously, we're doing that with Grafix for sure, with Ovation and with Cartiform and so we're very pleased with that. And ultimately, good economics, and we think we're doing a good job there, too. With a 72% gross margin, we're getting the type of economics that we're looking to see. And we actually think with additional opportunity and absorption, we actually have the opportunity to take that up a little bit. Now let me talk about Ovation OS. I mentioned this at one of the investor conferences I was on. We are now in the preparation stages of getting ready to launch Ovation OS. Ovation OS is basically a continuation of our Ovation line, but specifically designed for the treatment of bone regeneration. When we designed Ovation initially, it was as a topical wound care and wound repair matrix. It has tremendous utility there. But what we found was there were a number of orthopedic surgeons that really liked the product for things like spinal fusion in nonunions and other typical difficult-to-treat orthopedic cases. And so what we wanted to do was take advantage of that demand for that specific type of product, optimize the product and get it out there that can take care of that market. The orthopedic market for cell therapy is a very significant market. It's a market that we created when we launched Osteocel back in 2005 and it's a market where we always want to have a significant hand in. And so with the launch of Ovation OS, we think we're really going to do that. It's a -- it really is a very, very sophisticated, we think, the most advanced cell therapy product on the market for osteogenesis. And the reason is that product is inductive, which means it'll cause your body to grow bone; it's conductive, bone can go through it; it's osteogenic, it will grow bone; but the last piece is very important for us, it's also angiogenic. And what we've come to learn is that if you can't grow blood vessels in difficult-to-treat orthopedic lesions, you can't grow bone. Bone needs blood vessels to nurture it and that's one of the things that's been overlooked in other cell therapy applications and it's one we're trying to correct and fix with Ovation OS. So look for Ovation OS coming out before the end of the year. We're getting excited about its launch. Okay. I'll end here. Just summing up, our near-term strategic goal, they really haven't changed. They're looking to grow revenue. We're very pleased with the revenue growth we're going, at the same time, control costs. Obviously, we have to be investing in our commercial infrastructure if we want the top line to grow and we're doing that. And so our sales and marketing costs are going up. But things like G&A and other costs in manufacturing, wherever we can control costs, we're being very diligent about doing. Very focused product development, so we're not developing anything for everything. Instead, we're developing a very specific line of products which meet the criteria that we've laid out. We are working to generate positive reimbursement data. We're very pleased about the data we reported today in the 67 patient study, and we look forward to the larger randomized, controlled trial we have coming out. And then lastly, manufacturing efficiencies. As our volume grows up -- goes up and we have greater absorption in the manufacturing facility, we think there's opportunity to improve on the gross margin line as well. So with that said, I'll stop talking and look forward to taking your questions here. Question-and-Answer Session Operator [Operator Instructions] Our first question is from Ted Tenthoff of Piper Jaffray. Edward A. Tenthoff - Piper Jaffray Companies, Research Division This is Ted. Wanted to get a sense just with respect to sort of the rollout of Cartiform. Any additional color you guys can give along those lines? Are there sort of target institutions that you guys are looking at and maybe you can tell us a little bit about how that's pricing? Charles Randal Mills Yes, sure. So the rollout of Cartiform, as we mentioned on our last call, I would describe it as controlled. And let me start with your last question first because I think a lot of people would want to know why we would be so strict. So Cartiform is a tremendous product and that's a lot of things. But one of the things it's not is cheap. Cartiform sells for around $9,000 an application. And so it is a premium priced product because we believe the market will bear it because what it's replacing are things like condyle transplants or total knees, which are significantly more expensive than $9,000. And so for a minimally invasive product, we think, doing our market analysis, we think that's a reasonable price for Cartiform in its current size and its current configuration. I will also tell you we're working on different sizes and different configurations of Cartiform, which will obviously have different price points. But because of how significant the product is, we have been very controlled. So we are going out through a list of very targeted accounts. There is no shortage of surgeons that are interested in using the product. In fact, we just came back from AOSSM, which is the large sports medicine society meeting, this year it was in Chicago. We had a big presence there and we had a great turnout. And there's more demand and interest in the product right now, frankly, than we have the ability to have a sales team go out and a medical science liaison team go out and train them. So we're going to have a very controlled launch as we build up our commercial infrastructure. As that commercial infrastructure comes up and we can be with a surgeon for the first 2 or 3 cases that they do, make sure that they feel comfortable with using the product and then obviously sales are going to take off, we think. But for now, it's a very controlled effort. Because if you're going to spend, obviously, $9,000 per product, we want to make sure your experience with that product is definitively a good one. Now the thing I'm very pleased with is, as I talked about today, we're now a year -- now we're approaching 1 year with patients who have had Cartiform implanted and all of the patients here who received Cartiform so far are doing excellent, and in fact, are exceeding the surgeons' expectations for what they thought Cartiform would do. So we're very pleased with the clinical performance of Cartiform, but we also want to make sure that we get it out of the marketplace correctly. And I have people use it incorrectly and end up with adverse events for it. Edward A. Tenthoff - Piper Jaffray Companies, Research Division That makes a lot of sense. And apologies if you addressed this. I'm bouncing around a little bit between calls today. But with respect to this good outcome from the diabetic foot ulcer study -- or I'm sorry, the venous leg ulcer study, how do you use that data? And how does the DFU readout kind of fit into the overall plan for Grafix in terms of getting data out there? Charles Randal Mills Perfect. Great question. Very glad you asked that, Ted. So in the VLU study that we released today, basically, the other major arm in that trial was DFU. And so what we're looking to see there is how well the product is performing in venous leg ulcer against something else we know how it's performing, which is DFU. And so the first takeaway from that is, with regards to VLUs, which are generally regarded as much more difficult to treat, we are very pleased with the performance that we're seeing in that trial. And we're seeing DFU closure rates that are similar to what we've seen before. So we know we're looking at approximately the same patient population. The last piece to that puzzle we're looking for, and we'll get here hopefully by the end of the year, is the readout on the DFU randomized, controlled trial. And that will confirm for us the DFU closure rates that we'll actually see in the controlled trial. Once we have that information, then we think we'll have the pieces of the puzzle that we'll need to be able to design effectively and power a VLU trial that's similar in scope and quality to the current DFU trial that we're running. Our goal here is to be able to go into any wound care center of any meaningful size and be able to offer with objective, randomized, controlled, large scale, multi-center trials the clinician with data that can prove that Grafix cannot just fix their DFUs but really their entire spectrum of patients that they see. So our goal here is to put these pieces together and be able to use the information to design a high-quality VLU trial. Operator [Operator Instructions] Our next question is from Eun Yang of Jefferies. Eun K. Yang - Jefferies LLC, Research Division I just want to make sure that I understood the timing of Grafix. So Randy, you mentioned that there is an interim analysis for the ongoing Phase III studies. So when would that interim analysis be available? Charles Randal Mills Right. So the patients have to -- so it's approximately 100 patients and they'll have to complete the -- it's 100 patients between the evaluation period. We think, given where we are in enrollment, that will be in the third quarter. So this current quarter, as I mentioned also in the call, there's really 4 options there. One is that the interim analysis is planned. I mean, the trial just continues. We may have to -- we may come back and see that our powering assumptions were close, but not quite adequate and we might need to add some more patients to the trial that would obviously push it out a little bit in time. And then obviously, at both extreme ends, we could just discontinue the trial for overwhelming efficacy or for failure of utility. Eun K. Yang - Jefferies LLC, Research Division So previously, I think you guys mentioned that Phase III data would be potentially by year end. So if you would need to add more patient data, readout might be pushed out into next year, correct? Charles Randal Mills If we have to add more patients, then yes, I think it would take it out longer. That's correct. Eun K. Yang - Jefferies LLC, Research Division Okay, okay. But you would actually let us know what's the outcome of interim analysis? Charles Randal Mills If we -- if any -- if there's any materiality to the outcome, meaning if it's anything other than as we planned, we will obviously be making that announcement about it. Eun K. Yang - Jefferies LLC, Research Division Okay. And then you said the study is powered to show 20% absolute improvement compared to best of standard of care. How is the study powered? Is it 90% powered, 85% powered? What was the powering assumption there? Charles Randal Mills Yes, it's 80% powered and to detect a 20% difference. 20% is point, obviously. So 30% to 50%. Eun K. Yang - Jefferies LLC, Research Division Okay, right, right. Now obviously, this study is just for the reimbursement coverage and there are other cellular matrix products on the market. Can you talk about what would be advantages of Grafix compared to like Dermagraft or Apligraf? Charles Randal Mills Well -- so one, we're going to need, obviously, the randomized, controlled data to know for sure. When we look at the closure rates we're getting in the uncontrolled trials, they're significantly higher than what we've seen in the Dermagraft and Apligraf controlled trial. So Dermagraft was 18% in control versus 30%. The healing rate with Dermagraft, Apligraf was higher in both, so they had about a 38% closure rate in control versus 56% closure rate with Dermagraft. If we come in with a control that's below 30% and a closure rate that's higher than 50%, we think what we'll be offering is a significant improvement in close rate. The other thing we're looking at here, too, though, Eun, is the number of applications. And so in order to get the 30% closure rate, for example, with Dermagraft, they required 8 applications of the product. The median time to closure that we have been seeing in the open-label trials, and I fully understand all the limitations with the open-label trials, which is why we're doing the double-line control or single-blind control randomized trial here, is around 5 applications. And so the point, what we're trying to do here is create a product which not only heals the patient better, and it's better for the -- and better provides good outcome for the patient, but in doing so reduces health care costs. And if we can take the number of applications down and the number of failures down, because keep in mind, just take a look at the Dermagraft, the 70% that didn't heal after 8 applications of Dermagraft had to go on and get something else. And so that 70% of the patients that you paid for 8 applications of Dermagraft that got no benefit out of it. So we're looking to make a strong pharmacoeconomic argument, as well as a closure rate argument. Eun K. Yang - Jefferies LLC, Research Division Okay. And then also, you mentioned that this Phase III trial for Grafix is nearing completion of a patient enrollment. When do you think a patient enrollment to be completed in the third quarter? Charles Randal Mills Yes, I hate guessing exactly when, but maybe by the -- maybe some time -- keep in mind, it totally depends on whether or not we have to add more patients or not or whatever happens as a result of the interim analysis. But if we go to the 186, we're on track to get it all done this year. Operator And it looks like we have a follow-up from Ted Tenthoff of Piper Jaffray. Edward A. Tenthoff - Piper Jaffray Companies, Research Division I just had a follow-up with -- after all of Eun's questions on that. When it comes down to sort of plans larger for Prochymal at this point, looking forward, how does Prochymal fit into the overall strategy with respect to where you guys are planning on going? Charles Randal Mills Right. So this is something that I have talked about on some previous calls, but it's good to bring up. Prochymal is, obviously, our flagship product, first stem cell drug ever to be approved. When we had a partnership with Genzyme, we were actually very pleased with that partnership and liked the way that worked. When we -- when Sanofi came in and we were able to get the asset back in its entirety, we made a decision internally that the best thing for Osiris and the best thing for Prochymal would be for us to place Prochymal with a partner who would be able to develop the product the way Prochymal needs to be developed, and frankly, with the skill set that a drug company would have to develop the product further without us having to deviate from the significant success we're having with our Biosurgery products. So as we think about Prochymal going forward, we obviously want to be part of it. We want to benefit economically from it. But we are also going to need a partner really to lead that dance, both financially and from a development standpoint. Operator I'm not showing any further questions in the queue. I'd like to turn the call back over to Randy for any further remarks. Charles Randal Mills Great. Thank you very much, Ashley. I hope to see you guys. We have some upcoming events. We'll be adding to this as they come in. But we'll be at the Canaccord conference coming up, Medical Technology and Diagnostics forum, in New York in November. Piper Jaffray, obviously, Ted's conference, wouldn't miss. It's a very unique conference in a very unique setting. He sits down basically and grills me for 30 minutes. If you're a physician or health care provider, we would love to see you at any of these upcoming commercial activities, which we'll be presenting at or exhibiting at over the next coming weeks and months. With that said, thank you guys so much for listening. Thank you for staying with us and being part of our journey. We are very pleased with the third quarter -- or second quarter. And the way the second quarter came out, we hope to talk with you with more positive news as the third quarter concludes. Have a good day. Operator Ladies and gentlemen, thank you for participating in today's conference. This completes today's program. You may all disconnect. Everyone, have a great day. 

Gruss Hans

Hans
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Prochymal

Dieses Osiris-Medi ist nach wie vor bei Swissmedic in Prüfung und befindet sich auf dieser Liste

http://www.swissmedic.ch/daten/00081/index.html?lang=de&download=NHzLpZeg7t,lnp6I0NTU042l2Z6ln1acy4Zn4Z2qZpnO2Yuq2Z6gpJCDdH55f2ym162epYbg2c_JjKbNoKSn6A--&.xls

Anmeldung durch Voisin Consulting CH

Prochymal zählt zu den "Orphan-Drugs" ("Waisen-Erkrankungen", tritt per Definition bei höchstens 1 von 2'000 Personen auf) die gegen seltene Krankheiten eingesetzt werden, für die Pharmaindustrie ein vielversprechender Zukunftsmarkt (siehe Artikel in der NZZ vom 5. August 2013, im Internet nicht verfügbar).

Das Resultat der Prüfung bei Swissmedics sollte - falls sie sich innerhalb der angegebenen Prüfungsfrist von 330 Tagen bewegen - in den nächsten 3 Wochen bekannt gegeben werden.

Dies dürfte für die Osiris-Aktie richtungsweisend sein.

Hier ein Artikel zu Orphan Diseases:

http://www.nzz.ch/aktuell/schweiz/die-diagnose-war-schock-und-erleichterung-1.9582759

Gruss Hans

Samui
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Osiris News

 


Grafix® Demonstrates Overwhelming Efficacy in Landmark Stem Cell Study for the Treatment of Diabetic Foot Ulcers


Grafix closes three times as many wounds as standard of care - the largest relative improvement ever reported in a multi-center, randomized, controlled clinical trial for DFU


COLUMBIA, Md. - August 13,2013 - Osiris Therapeutics, Inc. (NASDAQ: OSIR), reported today that its multi-center, randomized, controlled clinical trial comparing the safety and effectiveness of Grafix® to standard of care in patients with chronic diabetic foot ulcers had met the pre-specified stopping rules for overwhelming efficacy as determined by the data monitoring committee during a planned interim analysis. For the primary endpoint, 62% of patients receiving Grafix had complete wound closure compared to only 21% (p<0.0001) of patients who received conventional treatment for their wounds - a relative improvement of 191% and the largest ever reported from such a study. A total of 131 patients were enrolled with the interim analysis being conducted on the first 97 to complete the trial.


 


 


FREUDE HERRSCHT - GEDULD BRINGT ROSEN - wenn da NEV nicht mit zieht verstehe ich die Börse nicht mehr.

Pegasus
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Osiris Th.

Oriris Heute im Moment 125.18 % UP, das warten hat sich sehr gelohnt;

http://www.osiris.com/pdf/2013-08-13%20Grafix%20DFU%20Trial%…

Hallo, hoffentlich seid Ihr ALLE  noch drin !!!

Eine Verdoppelung in einem Tag, das lässt man sich doch gefallen, verstehe nur nicht,
wieso in Deutschland z.B.  der Kurs nicht adäquat ansteigt, schlllllaaaaffffeeeen

die denn ALLE noch ?
 

Habe 4400 shares - mehrmals nachgekauft - gebunkert, Heute sind diese

CHF 52'500.00 im Wert gestiegen.

Ich möchte mich bei ALLEN, speziell aber bei HANS einmal bedanken für die immer

sachlich fundierten Beträge über Osiris Th.  

MERCI und weiter,

OSIRIS TH. GO, GO, GO


:):cool::rolleyes:;)

So wie einem das Licht nicht ohne die Dunkelheit bewusst würde, so gibt es keine Situation, in der nicht etwas POSITIVES zu entdecken wäre.

Frei nach I Ging

Samui
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Osiris / Grafix

laut Hans: erwarteter Markt ca.


Grafix for Burns ...................................................$150 bis 300 Mio
Grafix for Limb Salvage........................................$1 Mrd
Grafix for Diabetic Foot Ulcers (DFU)....................$2 Mrd


Osiris hat 33 Mio Aktien ausstehend, davon sind nur etwa 10 Mio freefloat. Short sind 2,3 Mio 23%! Da werden wohl einige margin calls bekommen und nachschütten müssen oder aber sich eindecken.


Träumen wir ein wenig:


Wenn man als Übernahme den Grafix Umsatz bezahlen müsste, dann sind das min. 3 Mia $ bei einem Aktientotal von 33 Mio -> also 3 000 Mio : 33 Mio = 90 Dollar.


siehe Zitat Hans:

$14 als Kursziel auf 12 Monate ist viel zu tief, da werden sich noch welche wundern...

 


 Und die Spekulation sieht etwa so aus:


Falls jetzt Osiris wirklich auf dem Radar einer grossen Pharmagesellschaft erscheint, dann beginnt dort das Rechnen, ein Übernahmecoup (unfriendly takeover) ist nicht möglich, da zu wenige Aktien im freefloat sind.


Mit den restlichen Medis in der Pipeline wären 100$ vermutlich ein Schnäppchen.


Nev besitzt 4.1 mio  Osiris  ca.-> 400 Mio CHF, wie viele Aktien hat NEV ausgegeben 5 Mio?


man darf ja träumen - ALLES OHNE GEWÄHR........


 

b00n
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Smile gratulation euch!

----gesperrt wegen gutmenschentum, wünsche an der stelle allen alles gute, wie immer. http://investorshub.advfn.com/boards/profilea.aspx?user=193864

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