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No, Endeavor uses durable polymer. BIG's patent covers any limus drug on biodegredable polymer. But the whole industry knows Endeavor is over-hyped and has below average performance. This stent will be a write-off if blood-clot problem ever happen to Endeavor. I believe their drug is no good but their durable polymer is better than other durable polymers used by other durable polymer DESs. I heard they are offering buy 2 get 1 free to the doctors here. One DES is selling around US$2,000. The doctors making easy money man.
FDA has issued draft guidelines to aid the development, testing and manufacture of DES (draft):
http://www.fda.gov/cdrh/ode/guidance/6255.html
hi bengster, is medtronic's zotarolimus-eluting stent infringing into big's patent?
| bengster68 Senior |
Posted: 27-Mar-2008 14:36 |
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A few months ago, i made a US$25m profit forecast for FY2008 and at least US$100m for FY2009. Looks like my forecast for FY2008 will not be met but this amount will rolled over to FY2009. I will revise and increase my net profit for FY2009 to be at least US$150m. That means BIG will have forward PE of below 4 for FY2009 at current share prices. |
Why do you say that this forecast cannot be met? are you aware of some event that has not taken place..? care to share.. and if there's delay, will this forecasted profit be reflected in the 1st Qtr of FY2009?
Recently I sold my shares at a small loss, and will not be invested until there some winds on any takeovers because really cannot stand the slowness. Will wait till June 2008 before buying as this will be a more appropriate time to start collecting. Now is unlcear and have to wait longer. I've moved on to other stocks that have better ranges and also stocks on NASDAQ & NYSE. Stocks like Google, Abbot, Dry Ship are my favorites.
A few months ago, i made a US$25m profit forecast for FY2008 and at least US$100m for FY2009. Looks like my forecast for FY2008 will not be met but this amount will rolled over to FY2009. I will revise and increase my net profit for FY2009 to be at least US$150m. That means BIG will have forward PE of below 4 for FY2009 at current share prices.
So many good news,BIG!!!!!!!!!!!!!AR!!!!!!!!!!!!!!!!!should CHIONG!!!!!!!!!!!!!!!!LIAO!!!!!!!!!!!!!!!
"TAK BOLEH TAHAN LIAO"
FDA Proposes Stent Guidelines
March 27, 2008
The Food and Drug Administration proposed tougher clinical-trial guidelines for drug-coated stents in response to concerns about blood clotting in the artery-opening devices long after implantation.
The move is the first concrete change since the FDA held a two-day meeting in December 2006 about whether such stents increase the risk of clots compared with bare-metal stents years after the procedure. Coated stents don't appear to increase deaths or blood clots overall; whether they increase late clots years after implantation is still debated.
Instead of assessing patients' progress and health in trials nine months after a stent is implanted, the agency will now require companies to submit trial data on patients' health one and two years after the procedure, before stents can be approved. The new draft guidelines appear to codify standards that the FDA used to assess trials for new stents from Medtronic Inc. and Abbott Laboratories.
The FDA's proposals are "relatively broad in nature and conform to the way the industry has already been thinking about product design," said Phil Nalbone, an analyst at RBC Capital Markets in San Francisco.
About a million people each year in the U.S. undergo procedures to treat heart-artery blockages. Stents prop open clogged arteries. Models coated with drugs to reduce reclogging, from Boston Scientific Corp., of Natick, Mass., and Johnson & Johnson, of New Brunswick, N.J., account for most of the U.S. market.
The guidelines aren't expected to affect coated stents already on the market, or cause further delays at Boston Scientific, which is still under a new-product probation from the FDA that has held up introduction of its next-generation heart stent in the U.S., said Mr. Nalbone.
The guidelines could affect up-and-comers such as medical-device company Xtent Inc., a Menlo Park, Calif., development-stage firm that is working to commercialize its stent. Gregory Casciaro, Xtent's chief executive, said the company had been planning for the new standards. "We've accounted for everything that we have seen" in the proposed guidelines, he said. Xtent's shares fell 5.2%, or 27 cents, to $4.90 in 4 p.m. composite trading on the Nasdaq Stock Market.
The FDA said that after a stent is approved, companies should continue monitoring, preferably for five years after implantation, for blood clots, heart attack or other complications. The guidelines are an effort to "minimize risks while preserving for patients the benefits of drug-eluting stents," the agency's device chief, Daniel Schultz, said in a statement. The FDA guidelines aren't legally binding, but most companies follow them to ensure approval of devices.
*** Why don't the FDA consider banning some of the existing DESs in USA market since they are the real culprits causing blood clots? This new guideline will make newer generation DESs from BIG, Devax, Xtent, etc taking a longer time to be available in US market and consumers there have no other choices but to continue using DESs with track record of causing blood clots. Another scheme by the Medical Device Mafia Inc just after approval of Endeavor and Xience.
Wednesday March 26, 3:32 pm ET
The stent is a tiny wire mesh tube used to prop open a clogged artery, while the drug coating on the device helps reduce the chance the artery will not clog again. The Food and Drug Administration approved Endeavor in February. It was the first drug-coated stent to reach the U.S. market since safety concerns sent sales plummeting two years ago. Several studies showed that the drug coatings had the potential to increase the risk of blood clots. A panel of federal advisers followed the studies up by saying the majority of patients with drug-coated stents have a higher risk of heart attack and death.
The decline in stent sales played a key role in Johnson & Johnson and Boston Scientific Corp.'s decision to cut jobs over the last several months.
Also on Wednesday, the FDA updated its guidelines for testing drug-coated stents, recommending large, analytic studies of the product both before and after they are submitted to the agency. Companies should be prepared to track patients for up to five years to monitor for blood clots and other potentially fatal issues, according to the new guideline.
"Xiao " BIG
still sleeping . CHIONG!!!!!!!!!!!!!!!!!!AR!!!!!!!!!!!!!!!
Siao BIG!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!CHIONG!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!AR!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
ST over 3000pts.U must do something lah
SHASHA!!!!!!!!!!!!!!!!!
100% agree with you man....!!!
INVEST WITH OUR OWN RISK ...!!!
AK_Francis ( Date: 22-Mar-2008 14:59) Posted:
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Agree with you.
Don't argue lah... the stock market is so volatile nowadays. You can be right one day and wrong another day. It is like a coin toss these days. 50-50 change.
ghlau935 ( Date: 21-Mar-2008 21:38) Posted:
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