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Is Biosensors a good buy?
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bengster68
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20-Sep-2008 14:16
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***Interfair: WHO INITIATE THE BIOMATRIX AND CYPHER TESTS? STILL VESTED. 
***Bengster: Biosensors of course. Only Biosensors dare to challenge Cypher after EndeavorIII failure against Cypher. All of Endeavor's end-point measurements are much weaker than Cypher's. Only Biomatrix has shown superiority against Cypher in all areas of end-point measurements although not wide enough to show statistical P-value superiority. Xience got no balls to challenge Cypher after seeing Endeavor's failure. All of Xience's RCTs are against Taxus. Biomatrix slam dunked Taxus Express and even the top-of-the-range Taxus Liberte. Who dare to do an "all comers" real world trial with no restrictions to treat the most challenging type of patient group? Who dare to do the OCT scan for endothelial recovery? Only the Best Of The Best dare to do it. Hope after UBS Life Science Conference got foreign institutional funds specialising in life science / biomed investments come in and mop up BIG shares big time. Tama'de this type of low share price is a hinderance to takeover negotiations man. Might as well privatise this company first then solicit for takeover bids. ***Interfair: YOU ARE RIGHT MAN! BUT WHY SHOULD J&J OBLIGE TO TAKE UP THE TESTS?
***Victory89: It's not up to JNJ to oblige to the test. The company that wants to do the test (in this case, biosensors) just chooses its competition and goes about doing the trial. This LEADERS RCT has its advantage and disadvantage. If you compare with Cypher, your margin of win will not be too big. Opponents of Bio might say that the stent is not too great. Just meets non-inferiority criteria. If you do a RCT with Taxus, opponents might still say that you have not compared with the best (Cypher). The later approach, however would have been a better approach because you can boast that you slam dunked Taxus. This is what Xience did... and its enjoying from this large margin of superiority. The best case RCT would have been a three way comparison (BIO vs. Cypher vs. Taxus) but this would have been too costly. I just hope either BIG or Terumo starts a large scale trial to compare Biomatrix against Xience. This will settle the debate once and for all. ***Bengster: I share the same sentiments as Victory89. When LEADERS trial was at initial planning stage a few years ago, they can only compare against the only 2 commercially available DESs namely Cypher and Taxus. Later on Endeavor and Xience got their CE (and now FDA), they are still the new comer. From what i see in this industry, Taxus and Cypher is obviously struggling and losing so much market share to newer entrants like Endeavor and Xience. These 2 new entrants will occupy the global top 2 best selling DESs next year. It will make sense to challenge these 2 top sellers if BIG wants to conduct another RCT and take over the global market leadership position. But BIG where got so much cash to burn? If JNJ buys over BIG, JNJ can immediately settle the FDA IDE lobbying problems, start FDA clinical trial immediately (restart STEALTH 2 RCT whereby Biomatrix VS Taxus). At the same time, start another massive scale "real world" 3,000 patient at 1:1:1 ratio RCT comparing all the newer limus drug DES (Biomatrix VS Endeavor VS Xience). It will be the biggest fight who is the real top class DES. Endeavor don't stand a chance against Biomatrix. Xience is using BIG's older generation Everolimus technology that BIG discarded to Guidant and durable polymer. Im confident Biomatrix will emerge the champion in this 3 way fight. By the time Biomatrix FDA approval is obtained, Biomatrix will be propelled into the global top selling DES, overtaking Xience's leading position within 6 months. This is what is happening now, Xience is becoming the global top selling DES within 6 months after their FDA approval. Mother's son.......... this company really need the backing of a powerful MNC to take its current products and next generation products to greater heights on global platform. Best Of The Best DES's CE got delayed for so freaking long, now FDA IDE still stuck.......... very costly to conduct massive scale RCTs. |
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bengster68
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19-Sep-2008 23:58
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Medical Device Makers Throwing Money Down the Tube By Brian Orelli September 18, 2008 Medical device companies may be the newest victim of Congress' power. And contrary to what you might think, that's probably a good thing. I've written before that advertisements for medical devices such as Johnson & Johnson's (NYSE: JNJ) drug-eluting stent, Cypher, don't make a whole lot of sense. And nothing I've seen since has made me change my mind. The Senate Aging Committee is currently investigating medical device companies' direct-to-consumer advertising campaigns. Unlike the ads from their pharmaceutical brethren, these ads don't have to equally weigh the benefits with the risks. Probably just as well. It'd be a real downer if they did because death is a potential risk of almost any surgery. Even if the worst happens from the viewpoint of the companies -- a complete ban on advertisements -- I still don't think it would really have that big of an effect on medical device makers like Medtronic (NYSE: MDT), Boston Scientific (NYSE: BSX), or Abbott Labs (NYSE: ABT). In contrast, pharmaceutical companies should be very worried about increased clamoring to protect patients from the "vicious" heath-care companies. Pfizer (NYSE: PFE), Eli Lilly (NYSE: LLY), Merck (NYSE: MRK), and the rest need the advertisements to get patients to talk to their doctors about their high cholesterol or erectile dysfunction. While they certainly boost sales, they also get patients talking to their doctors. And that's good. However, medical device makers are in a business where the doctors are most likely to make the decision to use a particular device. I mean if you need a knee replaced or a stent put in, you're probably already talking to your doctor about various options. Are patients really going to convince their doctors to cut them open just because they heard about a procedure on television? And even then, is the doctor more likely to use the device that patient heard about on television or the one the doctor is more comfortable using? The doctors are the ones who the medical device companies should focus their promotion dollars on, not the patients. Smart investors should keep an eye out for advertisements and invest in companies that aren't throwing profits down the tube. *** To counter loss of market share esp in USA, JNJ should have better DES weapon rather than throwing money on TV adverts which is not cheap. Should consider licensing Biomatrix for USA market. Probably a US$100m upfront licensing fee, another US$100m to burn for clinical trial to obtain FDA approval, some licensing milestone payments along the way and a give a royalty of sales to Biosensors. This is a more solid step to regaining their lost market share. Banging all their hopes on NEVO DES which uses a stent platform that has a consistent track record of clinical trial failures is not a good business strategy. With such a bad track record history, how to market this type of DES? Of course they have the option to buy over the most promising stent developer and develop the market themself. BIG's top class DES technology is already proven |
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A02041315
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19-Sep-2008 15:43
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BIG is oversold liao. good time to buy.
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XiaoMaGe888
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19-Sep-2008 15:19
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XiaoMaGe888
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19-Sep-2008 14:45
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BIG!!!!!!!!!!!Cheong!!!!!!!!!!!!!!!!!!!!!!LIAO!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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bengster68
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19-Sep-2008 14:02
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SJM just "clone" other people's products and can only sell in India. Cannot sell overseas. Kena patent issues. We have to see which stent has the best performance. Do you know what kind of Biodegradable polymer and limus drug SJM is using? My guess is Sirolimus. They will use the same biodegradable polymer they used for their Paclitaxel drug stent. So everything the same, just change the drug from Paclitaxel to Sirolimus. Any RCT clinical data on SJM's limus biodegradable stents? |
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PensionAlterEgo
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19-Sep-2008 13:40
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India market is about US120mill but i think this is going to be a difficult place to sell. The Sahajanand stents, which are a rip-off of most state-of the art stents looks likely to be the option there. This company even has a biodegradeable polymer limus based stent (A second generation stent), which is CE approved. Not sure what is JNJ's market share in India..
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allright
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19-Sep-2008 13:21
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ANNOUNCEMENT BIOSENSORS INTERNATIONAL GROUP, LTD. (Incorporated in Bermuda) (Company Registration Number: EC 24983) Biosensors to Participate in UBS 2008 Global Life Sciences Conference Biosensors International Group Ltd (“Biosensors”, “Company”) is pleased to announce that it will be participating in the UBS 2008 Global Life Sciences Conference which is being held from 22 – 25 September in New York. Mr Kevin Sayer, Chief Financial Officer, will make a presentation on 25 September 2008 at 1:30 pm EDT. A live Webcast of the presentation, hosted by UBS, will be available at the UBS website at www.ibb.ubs.com. To access this Webcast, go to www.ibb.ubs.com, click on the “Conferences” box, find the Global Life Sciences Conference heading, click on the “Webcast” icon. An archived replay will be available approximately three hours after the live Webcast and until October 25, 2008. By Order of the Board Kevin R Sayer Company Secretary 19 September 2008 | |||||||||||||||||||||||||||||||||||||||||||||
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bengster68
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19-Sep-2008 11:27
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INTERVIEW-Biosensors sees product revenues doubling in ''08/09 (2008/09/18 16:16PM) -------------------------------------------------------------------------------- SINGAPORE, Sept 18 (Reuters) - Medical technology firm Biosensors International expects product revenue to more than double in this fiscal year ending March 2009, from sales of its new heart stent. The Singapore-based firm expects product revenue to grow from $38.7 million in the past fiscal year to $65 to $75 million this year. Product revenue made up most of the firm''s $44 million total revenue last year, with the rest coming from licensing that is hard to predict. This excludes sales in China, where Biosensors is currently holding a 50% stake in JW Medical Sysytem said President R. Michael Kleine. "My focus is very much on top line growth," Klein told Reuters in an interview on Thursday. The firm, which develops and markets cardiology and critical care devices, received approval for its heart stent in India earlier this month, he said. (Reporting by Brenda Goh; Editing by NeilChatterjee) ((Brenda.Goh@thomsonreuters.com; +65 5403 5657)) ***Got UBS Biomed Conference later today and BIG is one of the participants. See if there are any updates. Biomatrix's China approval should be later this year. |
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XiaoMaGe888
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19-Sep-2008 09:33
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bengster68
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19-Sep-2008 00:06
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Its just some analyst talk about the DES industry. Whether its 28% or almost 50% (including BSX's private label Promus), it shows that newer and better DES like Xience (which uses BIG's older generation Everolimus DES technology) is clearly becoming the market leader. I personally feel that only Biomatrix has the edge over Xience DES. Biolimus drug, ablumenal coating technology, biodegradable polymer, etc. If a strong American MNC takes over Biosensors, im confident this MNC can bring up the status of Biomatrix and dethrone the market leadership position of Xience in 3 years time. Biodegrable polymer (Biomatrix) and totally polymerless DES (Biomatrix Freedom) is an excellent marketing platform and sales pitch for the MNC buyer to take over a lot of market share from existing players. BIG does have the clinical data to back up the marketing and sales pitch that BiolumsA9 drug has the best DES efficacy and biodegradable polymer / totally polymerless is holy grail DES is looking for with regards to thrombosis problems. | |||||||||||||||||||||||||||||||||||||||||||||
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dontalkrubbish
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18-Sep-2008 17:38
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Why is this article positive for BIG.. someone pls enlighten..
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XiaoMaGe888
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18-Sep-2008 16:00
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 So is best time liao,no need to wait!!!!!!!!!!!CHEONG!!!!!!!!
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PensionAlterEgo
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18-Sep-2008 14:26
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Based on some earlier data.. shown in http://www.theheart.org/article/898237.do Very rough estimates for Aug 2008 was Xience - 28% ; Endeavor 17% ; Taxus - 27% ; Cypher - 29% Now this JP Morgan guys says Xience is 50%. Assuming Endeavor stays at 17%, then Taxus & Cypher should me at most 16% & 17%, respectively. That's a very fast death..! Oh boy, at the rate it's going, I think Xience might just take 75% US share by year end. Then I wonder what's the rest going to do?
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bengster68
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18-Sep-2008 14:02
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Not quite sure about it. I also heard the tenders is normally around end of year. Some hospital groups have one "nominated vendor status" if they feel your stent is the best overall performance and allow you to stock up in their hospitals. Not sure when the sale is considered made under the second method. MNCs' branding marketing gimmicks are very strong. Medtronic's Endeavor is lousy but they can make doctors believe it is very good and safe. To me, Endeavor is just a good BMS. Some doctors even said Endeavor must be used if patient must be off Plavix blood thinnner drug because using Endeavor will lead to low blood clots. Might as well use a BMS instead? Haven't they seen Endeavor IV results where thrombosis rates are much higher than Taxus? This is one of the most stupid suggestions from doctors i have ever heard about using Endeavor. |
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PensionAlterEgo
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18-Sep-2008 13:41
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Bengster, do u know if the hospitals in Europe have a fixed tender period to procure stents? I remembered that BIG's CEO mentioned something like that during one of the quaterly results.... maybe towards the end of the year. I wonder what is the process in these tenders? Do they narrow down to say two stents and then get the companies to submit their tenders? I don't think hospitals will just narrow down to one .. , which defeats the purpose of a tender. Xience's marketing looks strong. Wonder what is Bio's chances in these tenders. It will have to use its biodegradable "unique selling point" to sell its stent! |
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PensionAlterEgo
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18-Sep-2008 13:21
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New SCAAR scare? Restenosis rates double in diabetics with Endeavor stent - September 2, 2008 Munich, Germany - Nearly two years after Swedish investigators shocked the cardiology community with registry data hinting that drug-eluting stents (DES) might increase death rates by 30% after six months, the Swedes are back with new data showing that the Endeavor stent is associated with more than twice the risk of restenosis in diabetics than the Cypher or Taxus stents. The new data were presented here at the European Society of Cardiology Congress 2008. According to Dr Bo Lagerqvist (Akademiska University Hospital, Uppsala, Sweden) the SCAAR registry data support calls for larger comparative DES trials, particularly in diabetic patients. "In this large real-world registry, there were large differences in restenosis rates between different types of DES with and without diabetes," he said. "This reinforces the need for larger, randomized prospective trials with head-to-head comparisons between the different stent types, both in diabetics and nondiabetics." Due to the nature of the nationwide registry, Lagerqvist et al's study looked specifically at restenosis on a per-stent (not per-patient) basis, making it impossible to compare the results with rates of other events like death or MI for the entire data set. But in a separate analysis that considered patients who had just one stent each, the risk of death and the risk of MI were no different between the different stent types, both for the entire SCAAR population and in separate analyses of diabetic and nondiabetic patients, Lagerqvist stated. SCAAR can still scare This latest analysis looked only at stent brands that have been implanted at least 500 times since December 31, 2007, thus including the Cypher, the Taxus Express, the Taxus Liberté, and the Endeavor (the Xience did not meet the 500-stent cutoff). During this time period, 35 478 stents were used, of which 23.2% were used in diabetics. The Cypher was the most commonly used stent in diabetic patients, at 2616, followed by the Taxus Liberté (2553), the Taxus Express (2182), and the Endeavor (881). Out to three years of follow-up, there were no significant differences in restenosis rates between the two Taxus stents and the Cypher in diabetic patients, even after adjustment for confounding factors. But when the Endeavor stents were added to the analysis, the relative risk of restenosis for diabetics was twice as high in the Endeavor as it was with the other stents. A similar analysis conducted in nondiabetic patients also pointed to higher rates of restenosis for the Endeavor, but not to the same degree. Relative risk of restenosis for Endeavor
*Not presented
In an intriguing, albeit unrelated, observation, restenosis rates were also 32% higher for the Taxus Express than for the Taxus Liberté and 24% higher for the Taxus Express vs the Cypher. "The influence of diabetes on restenosis risk differs with type of DES," Lagerqvist concluded. "In patients with diabetes, the risk of restenosis is doubled in lesions stented with Endeavor compared with lesions stented with Cypher or Taxus stents." What about hard events? To heartwire, Lagerqvist emphasized that the mortality analysis provides some comfort. "Of course, these data are meaningful for those patients who have to come back and have a second procedure, but the most important question is of course mortality, and we can't really see any differences in our registry." Dr Franz R Eberli (University Hospital Zurich, Switzerland), who chaired the session, told heartwire that he was "not at all surprised" by the SCAAR data, particularly since preapproval studies consistently pointed to higher late loss with this stent. "Even from clinical experience, you know that the Endeavor stents have more restenosis than Taxus or Cypher. Even the [ENDEAVOR III] trial of Cypher vs Endeavor in all-comers was negative; the Endeavor didn't meet the test for noninferiority, meaning that it was inferior." And there are "many reasons" why this difference would be more pronounced in diabetics, he added. "There may be a different pattern of using this," Eberli explained. "Endeavor is much easier to deliver, so inexperienced operators may be using it more often. This could be a confounder. And diabetic patients have smaller vessels, more calcifications, so it's harder to deliver the stent. Many people will say, okay, I have to get a stent down there; I don't care if the patient comes back a second time for another stent, it doesn't affect mortality." That said, Eberli is not completely reassured by the mortality analysis Lagerqvist presented. "There's a very nice study showing that in diabetic patients, patients who restenosis have a higher mortality, so higher restenosis rates with Endeavor could well effect mortality, especially if you look at multiple lesions and the more seriously diseased vessels. Some of these patients will have totally occluded vessels and will have to go to CABG surgery, so it could still have effects on mortality. But you would need 1000 patients or more to see a difference; this analysis included just 800 Endeavor stents." A Medtronic spokesperson responding to heartwire's coverage of the SCAAR data emphasized that company's clinical-trial and postmarket registry data demonstrate that the device has efficacy—target-lesion-revascularization (TLR) rates—comparable to Cypher and Taxus in all-comers, but with a safety profile more akin to a bare-metal stent. "If looking specifically at diabetic patients, in ENDEAVOR V, with 100% independent adjudication of all events in over 2500 diabetic patients, a low TLR rate of 5.3% was observed at 12 months, comparable to the overall rate of 4.5% TLR at 12 months," spokesperson Daniel Beach commented. Moreover, he emphasized, "one of the principal advantages of Endeavor is the healthy healing it promotes, which we believe contributes significantly to an unprecedented safety profile for a DES." While news of fresh SCAAR data will likely send shivers down the spines of interventionalists and market-watchers alike, many will remember that, at least in the case of the original SCAAR scare, time will tell. DES use had plunged from 60% to 15% in Sweden by the time late follow-up of the original DES-vs-bare-metal-stent data suggested that the mortality risk for DES was no different from that of bare-metal stents at four years. >> note the figures in red above. A factor of 2.18 times more restenosis for Endeavor compared to Taxus Liberte in diabetic patients. This is like BMS! BMS use to have too high restenosis compared to DES. In the long run, I believe rival companies will play up this point to hit Endeavor. I think when there is more of such results, Endeavor would probably not survive too long.. Note that the Cypher over Biomatrix relative risk ratio for (binary in-stent) restenosis is 1.58. This results is based on a patient mix having about 25% diabetic patients. |
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allright
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18-Sep-2008 13:11
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But the curb or control is USA not Singapore. Read in the papers that in Singapore there is no need to reveal short positions . But in HongKong they have to? | |||||||||||||||||||||||||||||||||||||||||||||
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bengster68
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18-Sep-2008 11:56
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Unless you participate in share lending scheme, your shares will not be loaned out. I think it is done thru the CDP. They pay you some interest but destory your share value. Shorting is realling quite a serious problem now but there are new curbs: 17/09/2008 - 15:49:17 US financial watchdogs today acted to stop aggressive forms of short-selling that were blamed in part for the demise of Lehman Brothers. Amid fears they could be used against other vulnerable companies in a turbulent market the Securities and Exchange Commission adopted rules it said would provide permanent protections against abusive “naked” short-selling. Unlike the SEC’s temporary emergency ban this summer covering naked short-selling in mortgage finance giants Fannie Mae and Freddie Mac and 17 large investment banks, the new rules apply to trading in the broader market. The new rules remove an exception for market makers in options on stocks from rules restricting naked short-selling and tighten anti-fraud regulations related to that activity. Short sellers bet that a company’s price will fall so that they can profit from it. They borrow shares of the company and sell them. If the price drops, they buy cheaper shares and use them to repay the borrowed ones, pocketing the difference. Naked short-selling occurs when sellers do not even borrow the shares before selling them, and then look to cover positions immediately after the sale. Another new rule will require short sellers and their brokers to deliver underlying shares in the transactions by three days after the date of the short sale, or face penalties. That rule takes effect tomorrow but was adopted on an interim basis and the SEC is seeking public comment on it for 30 days. “These several actions today make it crystal clear that the SEC has zero tolerance for abusive naked short- selling,” SEC Chairman Christopher Cox said in a statement. The agency’s divisions, including enforcement attorneys and market inspectors, “will now have these weapons in their arsenal in their continuing battle to stop unlawful manipulation,” he said. The new rules take effect at 12.01pm EDT (5.01pm Irish Time) tomorrow. Some investors contend that naked short-selling, if left unchecked, would have given hedge funds and other aggressive short sellers an unfair advantage to attack other victims after Lehman Brothers, which made the biggest bankruptcy filing in US history on Monday. Merrill Lynch – being bought by Bank of America Corp. in a $50bn deal – or giant insurer American International Group, rescued with an 85 billion dollar cash injection from the Federal Reserve, were said to be among the likely targets. By Reuters | 17 Sep 2008 | 10:40 AM ET New SEC Short-Selling Rules Vow 'Zero Tolerance' New rules aimed against abusive naked short selling of stock in all publicly traded companies were issued by the U.S. Securities and Exchange Commission Wednesday. The SEC's new rules, which include a requirement to deliver a security by the settlement date, are effective Thursday. "These several actions today make it crystal clear that the SEC has zero tolerance for abusive naked short selling," SEC Chairman Christopher Cox said in a statement. Short sellers and their broker dealers are now required to deliver securities by the close of business on the settlement date, which is three days after the sale, or they will face penalties. Broker-dealers failing to comply will be prohibited from further short sales in the same security unless the shares are pre-borrowed. That prohibition on the broker-dealer's activity will also apply to all short sales for any customer. The SEC also adopted a rule that deems it fraudulent for customers to deceive broker-dealers about the intention or ability to deliver securities in time for settlement. The third measure the SEC adopted requires option market makers to deliver securities by settlement date. A "naked" short sale occurs when an investor sells stock that has not yet been borrowed. Broker-dealers will sometimes accidentally fail to deliver stock to investors who have arranged to borrow it. If this is done intentionally, it is already illegal. *** The rest of the major global stock exchanges may follow soon. SEC May Require Hedge Funds to Reveal Short Positions Sept. 17 (Bloomberg) -- The U.S. Securities and Exchange Commission, responding to a market rout this week, may require hedge funds to disclose their short-sale positions and plans to subpoena the funds for their communication records. Hedge funds and other investors that manage more than $100 million in stocks would be ``required to promptly begin public reporting of their daily short positions,'' SEC Chairman Christopher Cox said in a statement today. The agency's enforcement division will obtain ``disclosure from significant hedge funds'' regarding their ``past trading positions in specific securities,'' Cox said. Lawmakers including U.S. Senate Banking Committee Chairman Christopher Dodd and regulators say short sellers may have contributed to the market crisis by spreading false information and using abusive tactics to attack companies. Hedge funds and other investors argue that poor business strategies are to blame, not short sellers. The SEC rule requiring hedge funds to disclose short positions must be approved by the full commission to become binding. Separately, the SEC earlier today adopted two regulations that may pressure traders and brokers to actually borrow shares used in all short sales, amid concern investors are driving down prices by flooding markets with sell orders. A third rule makes it a securities fraud when sellers deceive brokers about delivering borrowed shares to buyers. |
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XiaoMaGe888
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18-Sep-2008 11:46
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