Latest Forum Topics / Biosensors | Post Reply |
Is Biosensors a good buy?
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bengster68
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04-Nov-2007 23:42
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CE do not need massive clinical trial enrollment like 2000 patients to grant you CE approval. Normally about 200 patients trial should be sufficient. But FDA requires massive clinical trial enrollment of about 1500 patients and require RCT to proof non-inferiority against an existing FDA approved DES. That is why most DES makers go for CE first, then followed by FDA and they will adjust the trial end-point measurements to fit in the non-inferiority criteria that FDA requires. Its like in pharma industry drug approval, phase 2B is a smaller scale trial, if ok, then proceed to phase 3 (larger trial) and adjust for certain mistakes made in phase 2B. | ||
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agathos
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04-Nov-2007 20:49
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Your are right Huatah, I am in the pharmaceutical industry. Any trials usually will have quite a large number of patients. The reason is we don't want to pick up VERY COSTLY post marketing side effects which can be potentially very embarassing, cause a DENT on resources, profit and create a messy PR scenario. On and off, u will notice COSTLY recalls and lines of pharmaceuticals and medicine being STOPPED abruptly. Vioxx (very strong pain killer), Hormone Replacement Therapy (HRT) pill by Wyeth and another recent recall is Prexige if I am correct. One day, doctors are happily prescribing it, next morning, a world wide recall. A TOTAL chaotic situation no listed company with a vested interest in consumer health would envy themselves to be in! That's the BIG challenge for BIG, and for that matter, any company that desires to market technology.It's the hiccup phase right now. To all fans out there, including myself, hopefully the BIG wait will be over soon! Agathos. WA (Perth). |
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huatah
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04-Nov-2007 20:35
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Hi Bengster, Tks for the feedback. I cant deny that BIG has de best product so far, but the managment team that consistently changing could be double-side sword. That's my very concern only since Aug 2005 I followed this counter. Hi Agathos, Patient......by this month, should be over.. haha.. but still.. cross finger lah.. Big Heart.. Definitely Yes.. cos if BIG get its CE Mark, you will see this counter going at a rate that never look back... Must have a BIG HEART to take it rite.. |
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clauswu
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04-Nov-2007 19:51
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BIG's mistake with CE application was that it has no trial with large patient numbers (> 2,000 - 3,000) that shows significant better results than other stents. That's what Health Authorities are looking for, not many small studies where it is much easier to show a benefit. Having Temasek or GIC as partner would probably not help in Europe, we shouldn't always ask for Government help. Nasdaq listing is a double-sided sword. BIG may get wider exposure to US investors but it requires a lot of resources (people and money) to maintain listing. Remember that Creative Technologies de-listed not too long ago because it was too costly to keep Nasdaq listing. |
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agathos
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04-Nov-2007 17:04
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Dear fellow Share junctionites & Bengster, Thanks for your postings. I too, am excited with bengster's knowledge and willingness to share his knowledge with us here in this forum. I do know that the CE mark was one of the key deciding factor in the upward share movement price of BIG. In fact, an experience share analyst told me to buy BIG if I have a big heart. That was last year in October 2006. I ignored it and the price went from 60 plus cents to 90 plus cents. Then, now it is going up again. I guess the share analyst was correct - this is ONE share where we got to be patient. I guess it is not for the faint hearted. Neither is it for punters. By the way, I am bleeding with that silly Chip Eng Seng, the only penny stock that i lose money in this volatile market. Other shares like Noble Group, I have gained kopi money within days or weeks (Although I have not sold them yet). With Bengster's detailed knowledge and our patience, let's wait for a while. If this share has good potential, a great management team with fore sights and solid business model, it will turn around. Someone may even want to swallow it up, which BIG is not keen since it sense it can stand on its own 2 legs! vested in BIG, Western Australia (Southern capital of the Wait A while land). |
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Maxximo
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04-Nov-2007 14:26
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I was just wondering since there is so much of biasim and political in this medical arena .... why not BIG seek our local big guns like Temasek and GIC as VC partner and lend a helping hand in getting the CE certification ...... Furthermore, Singapore is also promoting itself as a bio-medical hub ... so it does make sense ..... ( Or are they already vested in BIG liao ??? hahaha ) Look at Hyflux, F&N .... they just went in and everything moves .... of cos except CAO .... but now also not too bad wat ... Just my personal 2 cents view ..... Cheers to all BIG supporters .... CE will be the best X'mas present for us all ..... let's keep our finger cross .... hold ... hold ...hold .... |
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bengster68
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04-Nov-2007 12:07
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This is a MNC question. I only retail investor lah. But R&D at the highest level normally is in USA where there is a ready pool of consultants, experts and other resources. There has to be a critical mass of support function available to make it a R&D centre. Singapore is perhaps and out-post for these R&D activities? China better don't do any serious R&D there. The Chinaman will photostat your whole production manual, kelong the clinical trials to get approval, and set up a factory opposite your one and approach all your customers. A lot of MNCs discover they cannot do high level of R&D in China because their employees and the whole country do not respect IP rights. I don't think the location of R&D centre will affect NASDAQ listing. The key thing is finding issue manager and under-writer and the valuation during the NASDAQ IPO. When the 3 venture funds invested UD$45m convertible loan stock, one of the conditions is if BIG is listed in US, these loan stock will be converted into the US shares. BIG's rumour on NASDAQ listing plan has been around for more than one year already. The CEO is very unhappy that his share price is unappreciated in SGX and he said before if share price is still so cheap that after CE approval, he will do a dual listing in NASDAQ. He said his life asset is in this company and he wants to bring up the valuation of BIG and make long term shareholders benefit as well. I noticed they have been changing CFO (i think twice) until they got this ex-NYSE CFO guy. Not many CFO in Singapore is well-versed in NASDAQ listing procedures and reporting. I think only less than 3 such CFO is available in Singapore. So i feel BIG may be quite set on NASDAQ based on my assumption on what the CEO said previously and BIG's hiring of ex-NYSE CFO as their new CFO. But then again, coporate plans may change from time to time. |
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huatah
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04-Nov-2007 09:18
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Hi Bengster, Like eastwind and many others, deeply appreciate your indepth knowledge and unselfishness contribution to this forum on BIG. A die-hard believer of Bio's potential myself, would like to seek your feedback on the following based on your contacts and awareness. Do you think that it make sense for BIG to shutdown its USA R&D and shift it elsewhere (could be Spore/could be China)? If this is the case, listing in Nasdaq (as per your indication which should be sometimes 1st quarter next year) any issue? |
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EastWind
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04-Nov-2007 00:35
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all said and done, real world that we live in, BIG needs CE approval - and fast. Lets hope that it will arrive real soon. | ||
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bengster68
Master |
04-Nov-2007 00:25
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Confirm dirty tricks in medical industry also. Medtronic recently settled a multi-million civil suit. Apparently, FDA caught Medtronic giving kickbacks to doctors that uses their products. I heard it is quite an industry norm to give the doctor a kickback sum of 10% of the selling price. Say if A certain DES was sold for $5,000, the doctor will receive $500 directly from the DES seller. The hospital normally mark up another 25% and bill the patient $6,250 just for the DES alone. The patient paid the highly marked-up DES price (including doctor's kickback plus hospital mark-up) plus pay the doctor consultation and angioplasty ops fees and end up with the worst DES in his heart and die with blood clots. I have met some specialist doctors insisting on using a certain brand of medical products only. Later i found out that brand that the doctor wanted to use is one of the worst performing product and this is happening in Singapore also. KNN these doctors must be hanged also. Freaking murders!!! | ||
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bengster68
Master |
04-Nov-2007 00:08
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Oi Mr Investor! We were all waiting for your highly respected views and unbiased opinions. Regarding the NOBORI CORE trial, I heard it also on the symposium on TCT2007. I thought it was LEADERS trial: Biomatrix Vs Cypher. I think you are right. The MACE rate figures are 1.9% (NOBORI) VS 4.1% (Cypher), which was correct but i think i got the RCT trial name wrong. The Ang Mohs were talking non-stop for 2 hours and i listen until quite blur but im sure i got the MACE rates figures correct as i jotted it down and post it on this forum on 22/10/07. Walau Biomatrix submitted for CE on Apr 2005. Super long delay already...... Anyway NOBORI will be the number one best selling DES in Japan for sure. Japanese will buy Japanese brand only. More royalties will come in very soon. Plus, Xtent and Devax will be just behind BIG and Terumo's CE. What a new emerging dominant force in the DES landscape! I also want to correct an error on my earlier post today. Global DES market share are as follows: Boston Scientific (BSX) 46%, Cordis (JNJ) 39%, Medtronic (MDT) 8%, Abbott (ABT) 5%, others 2% But these figures will change very soon. Note: MDT and ABT figures are excluding US market but i expect both of them to be approved at end 2007. BSX has the worst stent performance but they are the market leader. What the bird!!! Taxus is very expensive and performs the worst and the drug they used is toxic in nature. Even we as layman also can conclude Taxus is the most lousy DES but cardiologists are still using them in largest quantities and recommending their patients to use Taxus. Confirm something is not quite right here. FDA should investigate kickbacks to doctors for using a certain DES brand. Medical industry is also a very dirty industry. Good to have so many DESs trials against Taxus and now the whole world knows Taxus is the worst DES and i expect BSX's sales will drop very drastically in 2008 and esp 2009 when Biomatrix penetrate into the US market. |
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EastWind
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04-Nov-2007 00:01
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Terumo Corporation ("Terumo"), is one of the licensees of Biosensors? drug-eluting stent technology. The Nobori drug-eluting stent utilizes Biosensors? technology that includes the S-Stent as a platform, a biodegradable polymer, and the anti-restenotic drug, Biolimus A9. Therefore, I dont think that Terumo will get it ahead of BIG. Unlikely that the licensee can get CE ahead of the licensor. But I do agree that there could be a certain bias against a small singapore company like BIG. Do you think that if it was J&J or Abbott that had BIG's technology, the CE would have been delayed so long? This may be a device used to save lives but make no mistake about it - it is still a cut throat, dog-eat-dog business like any other business. A friend of mine who used to sell such stents to local heart surgeons here told me she had an enormous entertainment budget. I recall that her company (one of the big ones aleady mentioned in this forum) even sent the doctors who buy their stents for overseas medical conferences - but in reality it was really a paid holiday to thank the doctors for buying their stents. So, ultimately even if BIG has the best stent, it must play ball - and be prepared to have a huge enertainmen budget to wine and dine the surgeons.. To get market share, you must do what everyone else is doing. This is the real world man. This is gonna involve dirty politics and big money and that is why I think the best way forward for BIG is NOT to do this alone. They have got to sell out or enter into an alliance with the big boys to create more economies of scale. But think about it - some of the biggest and most prominent global players in the world are using BIG's technology and paying it royalties! How come we are not proud of this? How come no one realises this? Its like Microsoft paying royalties to a small singapore company to use their software! It can only mean that the industry players know that BIG has the best stent. So, do yourselves a favour, fellas. I have been following Mr Beng's analysis for a very long time and I can tell you, this guy knows his stuff. If you think you have got a gem and at such a cheap price, do yourselves a favour - freaking HOLD! The problem with most punters is that they punt for a few cents profit. For what? My 2 cents worth - but I hope that BIG will be worth that fortune to all of us one day. |
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investor
Senior |
03-Nov-2007 22:49
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After looking at Nobori's excellent results, as well as the fact that they have released ther phase 2 clinical results, I am thinking that there is a possibility that Terumo may get the CE mark ahead of Biosensors. My reasons are : 1) Terumo has aready submitted thier CE mark application (mentioned in their corporatye ann), and my best guess is that it is probably after TCT2006 (End 2006), that means a 1 yr time frame, as at now. 2) Nobori's phase 2 results are very good - this will not give the CE authority a chance to reject the approval without appearing to be bias. 3) Terumo also conducted a registry (Nobori against the Cypher stent) - probably abt 100 patients, using the mace rate as the primary endpoint, and the results were briefly mentioned by Eberhad Grube - I think the mace rate was 1.something against 4.something (Nobori vs Cypher). This registry is call ' Nobori Core' and was presented also in TCT2007, but no details were given, except for the brief mention by Grube. 4) Terumo is a giant medical company in its own right and quite successful in Europe and are higly experience in the area of getting approvals for their products. Just some food for thought - NOT an inducement to trade. Also, take note that XTent's share price has been maintaining their recent 'highs', despite the recent turbulence in the US mkt - again, the clinical results are probably having an influence on the price. |
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bengster68
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03-Nov-2007 22:09
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Don't read too much into this quarterly financial report conference. Everything they say will be expected. They have been doing that every quarter. They most important event now is to wait for the trading halt. As for the placebo effect, Biomatrix CE was submitted Apr 2005. Thats 2.5years already. I recall Costar (the failed DES from Conor) was submitted for CE on Feb 2005 and they were approved in Feb 2006, exactly one year later. So, technically CE has been delaying the best DES for 1.5years and preventing needy patients from having access to the best clinically proven DES in the world. The worst DES they approve it so fast, the best DES they delay infinitely. What is CE trying to do here? Prejudice against Singapore company? Confirm got kelong inside. | ||
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A02041315
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03-Nov-2007 16:56
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Mark Ge from CNA posted: BIOSENSORS TO HOST GLOBAL INVESTOR CONFERENCE CALL TO DISCUSS FISCAL YEAR 2008 SECOND QUARTER AND FIRST HALF FINANCIAL RESULTS on12/11/2007. You think if BIG prospects not bright ,BIG will hold investor conference,THINK!THINK!THINK!!! So vest early dont miss making$$$$$$$ Good luck BIG supporters!!CHEERS |
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Manikamaniko.
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03-Nov-2007 16:37
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Will there be any "Placebo Effect" of this on LMA? |
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bengster68
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03-Nov-2007 15:48
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Investor's Business Daily The race is on among medical device makers to grab bigger pieces of a shrinking market for cardiovascular stents.
The latest entrant is Medtronic (NYSE:MDT - News), with Abbott Labs (NYSE:ABT - News) coming up fast on incumbents Boston Scientific (NYSE:BSX - News) and the Cordis unit of Johnson & Johnson (NYSE:JNJ - News).
The agency had said it was "aware of recent data suggesting a small but significant increase in the rate of death and myocardial infarction (heart attack) possibly due to stent thrombosis (a blood clot in the stent) in patients." After the hearings, the FDA's experts called on manufacturers to give doctors and patients stronger risk warnings. The panel also recommended that the FDA tell doctors to keep stent patients on aspirin and Plavix for a full year after implantation of a drug-eluting stent. Plavix is an anti-clotting drug jointly marketed by Bristol-Myers Squibb (NYSE:BMY - News) and Sanofi-Aventis (NYSE:SNY - News). Slumping Sales Since the alarm bells sounded, sales of drug-eluting stents have fallen. They had been $6 billion worldwide. The market now is $4 billion to $5 billion worldwide, says John Capek, Abbott's executive vice president of medical devices. Abbott seeks FDA approval for its Xience V drug-eluting stent. It's playing catch-up with the Cypher stent from Cordis and the Taxus Express2 from Boston Scientific. Those products got FDA approval in 2003 and 2004, respectively. Abbott will be fourth to market in the U.S. behind new entrant Medtronic . On Oct. 10, an FDA committee unanimously recommended approval for Medtronic's Endeavor stent. Twelve days later the European Union approved Medtronic's Endeavor Resolute stent, a variation of the U.S. model. Medtronic will start selling the EU-approved stent in 50 countries by the end of the year. It expects FDA approval for the U.S. stent by year-end, says Scott Ward, president of Medtronic's cardiovascular unit. He predicts a "blockbuster launch." "We're prepared to flow 100,000 units onto the U.S. market within 30 days of approval," Ward said. Ward concedes the market is far from certain. Drug-eluting stents once were used in 90% of angioplasty operations. Now they're used in 60% to 65% of those procedures, Ward says. Some doctors have turned to bare-metal stents. Still, Ward figures Medtronic can overcome the challenges of selling into a suddenly shaky market. He says the Endeavor stent has shown a lower rate of heart attack and stent thrombosis than competitors. My Stats Can Beat Your Stats This is where the industry's stent wars become statistics wars. Makers of drug-eluting stents have been running tests to compare their own stents with those of their competitors. The result: a deluge of data that confuses and often conflicts. Last November, Boston Scientific released a study done in the Netherlands that showed its Taxus drug-eluting stent had a lower rate of re-intervention and equal or lower instances of death or heart attack than the Cypher from J&J's Cordis unit. In June, Cordis responded with data of its own from a Danish study. It found that patients on Cordis' Cypher stent were less likely to need another operation at that same site than patients who got a Taxus stent. Three weeks ago Abbott said its developmental Xience stent showed a 43% reduction in "major adverse cardiac events" after one year compared with Boston Scientific's Taxus. Another study, completed in April 2006 and funded by Cordis, found that inaccurate placement or deployment of stents by surgeons, in the words of the FDA's Web site, "was strongly correlated with the development of restenosis (re-blockage)." The study found that drug-eluting stents were poorly installed in two-thirds of cases. In those instances, 5% of patients needed another surgery compared with 2.5% for those with well-placed stents. Two studies released at a European conference in September compounded the confusion. One, funded by Sanofi-Aventis and conducted by a consultant for Bristol-Myers Squibb, showed that heart attack victims who got drug-eluting stents in emergency surgery were five times likelier to die after two years than those who got bare-metal stents and Paxil on the side. The other showed no major difference between patients who got drug-eluting stents and those who got bare metal stents. It found that patients with drug-eluting stents faced a 1% added risk of death. Meanwhile, Medtronic has begun an 8,800-patient trial pitting its Endeavor against J&J's Cypher. It will be the largest randomized stent trial, Ward says. "We think that Endeavor will increase utilization of drug-eluting stents, putting usage into the 70% range or higher once physicians have access to a safer stent," he said. Endeavor should be a successful niche product, says analyst Jason Wittes of Leerink Swann, which has done business in the past 12 months with Abbott, Medtronic and Boston Scientific. "We think it can get 15% of the market," he said. The future of stents seems to lie with Abbott, Wittes says. "People look to Abbott for the next generation." New Frontier Abbott is working on a drug-eluting stent that dissolves, unlike metal stents. Called Absorb, it's now in first trials in humans. Thirty patients signed up for the early trial, with one dropping out after developing a cardiac problem. That's a low side-effect rate, Capek says. The biosoluble stent could be on the market in Europe by 2011 and 2012 in the U.S., Capek says. "If it works as well as metal stents, it could be a replacement product for all the drug-eluting stents we have today," he said. *** Someone here asked about global DES market size so i got this article for your reference. I think currently Xience has about 9% of market share (before FDA approval). Endeavor has about 6% market share (before FDA approval). I think it should be reasonable for Biomatrix to have 10% market share by 2010 after FDA approval (which i expect in 2009). Before FDA approval, i expect Biomatrix to capture 5% of global market share. By 2010, market size should be US$5B a year. |
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bengster68
Master |
03-Nov-2007 15:36
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Biolimus is analog version of Sirolimus (a derivative of sirolimus). But Biolimus is fat-seeking so it works better than Sirolimus. MIVT's bio-ceramic DES technology is questionable. I have asked BIG's CEO on this before. MIVT presented at TCT2007 only has 15 patients for 4 months with high late-loss figures at 4 months. MITV's DES, if ever approved, will be about the same time as BIG's next generation DES Biomatrix-Freedom (totally polymerless). Previously BIG's CEO also said Conor's Costar is questionable and its design is flawed and Costar will suffer from performance problems later on. He said this while everyone else in the DES industry was saying Costar's revolutionary and novel design is the next big thing in DES industry. The CEO was spot-on in Costar and proven right in May 2007 and deserves my respect for him. I think he knows JNJ will come back to BIG again after buying Conor. He refuses to sell BIG cheap because he knows how how BIG is truly worth. BIG is still grossly undervalued even at today's share price. This guy is really a "professor" at DES and he knows the strength and weakness/flaws of each and every DESs available. There are many of such "revolutionary" new medical products with new and wild claims in future potential and the main aim is to want investor's money so treat it such claims with a pinch of salt. Until they can prove superiority in RTC against other DESs then the company is worth a second look. Most of them are kelong and will never be commercialised eventually. However, not only will BIG's product be able to commercialised very soon, BIG has a real potential to be a DES major globally. BIG has proven clinical trials that win leading DESs by very wide margins in all end-point measurements. This is a pre-earnings company and this is where we investors take comfort in. I said before if BIG's trial results are only so-so, i would not be bullish or be vested in BIG at all. I know BIG will be a global DES powerhouse eventually. |
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Younglady
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03-Nov-2007 12:11
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how how???? bengstar i think u mention alot short form and too profound??? can u explain in more simple and concise???? pls, thks. and all can give advise. I dun chek ark i lose alot hahha | ||
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cwwan1
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03-Nov-2007 12:09
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http://www.bloomberg.com/apps/news?pid=conews&tkr=MIVT:US What is the differnce between biolimus and sirolimus? |
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