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Renu Virmani also did animal clinical testing on the Bio-matrix, vs the Taxus and Cypher.
The results shows the bio-matrix to have good endothelialised function and minimal inflamation, just like the Xience, Endeavor.
THe difference is even more striking when there is stent overlap, in the overlapped areas, where there is a lot of metal struts exposure in the Taxus, cypher stents.
Bottom line - most of the new stents have better endothelialised functions, less inflammation, BUT only one (ie the Bio-matrix, Nobori, XTENT) reverts to a bare metal stent in 6-9 mths.
A doctor ( I believe it is Dr. William Wijins from OLV Hospital) says and I quote him '? I have seen the results at six months of the cases done at our hospital—you simply do not recognize the vessel.".
He wass talking about overlapping stents.
I wonder what kind of impact this will have on new medical device companies including Biosensors as they try to enter the American market.
Moody's: Enhanced FDA Scrutiny Could Pressure Device MakersLast update: 7/10/2008 1:37:11 PM
By Jon Kamp
Of DOW JONES NEWSWIRES
Heightened Food and Drug Administration surveillance for problems with products already on the market could pressure medical-device makers by boosting research-and-development costs and the risk of negative news, according to Moody's Investors Service. Manufacturers of high-tech devices such as drug-coated stents - which are made by Boston Scientific Corp. (BSX), Johnson & Johnson (JNJ), Medtronic Inc. (MDT) and Abbott Laboratories (ABT) - appear to be most vulnerable to the increased scrutiny, Moody's said in a report issued Thursday. The credit ratings firm examined the impact of an FDA plan announced in May, called "Sentinel", that aims to comb health databases from a variety of sources to identify product issues more quickly. "The increased scrutiny could lead to greater volatility in sales and profitability, or even a prolonged downturn in credit fundamentals, for some medical device companies," Moody's said. The FDA's focus on so-called post-market studies, or often lengthy and costly studies that companies must perform once a new product is approved, will push up R&D costs for device makers over time, Moody's said. While the FDA's increased scrutiny also affects drug makers, Moody's that that clinical trials for new drugs before and after approval already represent a large portion of development expenses. In the device sector, Moody's noted that the FDA has required long post-market studies of recently approved drug-coated stent heart devices, which prop open clogged arteries, from Medtronic and Abbott. Those devices entered a market that was rocked in 2006 by safety concerns regarding older devices. Meantime, pharmaceutical companies have the same exposure as device makers to fallout from bad product news when it erupts, Moody's said. The ratings firm believes that over the long haul, the FDA's efforts could create greater consumer confidence that could help sales if medical devices prove safe and effective. "That said, more negative reports on medical devices could emerge, making the government's postmarket monitoring efforts more of a risk than a benefit for the sector over the next several years," Moody's said. The firm said that key issues will include how companies deal with higher R&D costs, how data on products are analyzed and reported, and the extent to which such information is used to guide FDA actions.
Animal studies, while interesting, often don't predict what will happen
in humans. However, Dr. Virmani's early animal studies on both the
Cypher and Taxus polymers did show concern that they caused
inflammation and fibrin deposition long term. Years later, human
pathological samples from Cypher and Taxus implantations started
showing up in Dr. Virmani's lab showing the exact inflammation and
fibrin deposition as the animal models predicted. The animal data on
endothelialisation is also interesting but again, it is uncertain if it
is predictive of human results. What Medtronic did not show on it's
slide is that Dr. Virmani did these studies on 4 stents. The Xience
stent was also included and showed the best results by far. Perhaps not
all permanent polymers are bad. If I was you, I would choose Xience over the other 3. I would love to see more scientific data on Bio-matrix.
investor ( Date: 10-Jul-2008 21:40) Posted:
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There is no science behind this 'new' school of thought. It is simply
Medtronic marketing trying to justify the use of a poorly performing
DES. Late loss is often misunderstood. A late loss of 0.62 does not
mean that every stented lesion will reduce in size by that amount
becuase if it did, there would be no TLR. The late loss number is a
bell curve average; some patients will experience less and some more.
It is the patients that experience more that drive the TLR rates. The patients in these device company studies are carefully selected and
represent the 'simplest' of coronary artery disease. The lesions are
discreet and there is not much disease in the rest of the coronary
arteries. These patients represent a tiny fraction of the total number
of patients that would show up in a cardiologist office daily. The
early Endeavor trials that extend out to 4 years are made up of exactly these type of patients and
they are not as susceptible to higher late loss numbers. That is why
you don't see large changes in the clinical measurements of MACE, TVF
etc. It is in the majority 'real world' patients, with smaller, more
diseased vessels that the higer late loss becomes much more
problematic. There is however, no evidence that the Endeavor permanent
polymer is a problematic. It seems more biocompatible than the Cypher
or Taxus polymer.
investor ( Date: 10-Jul-2008 14:23) Posted:
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as compared with GenItl, this one is considered cheap alrdy. The main reason is GenItl will only see lights in 2010, whereas BIG will show its strength by end 2008 till Mar 2009, if world don't cough out dissaster within these periods.
If Zotarolimus is good, Abbott would have commercialised this drug in their own DES long ago. Zotarolimus is Abbott's own in-house drug. See the code name for Zotarolimus is ABT-578??? ABT = ABBOTT. A few years ago, Abbott spent a few hundred million on a DES program called Zomax but Zotarolimus just cannot make it lah. So they discard the whole DES program and spend US$4.1B to buy over Xience DES program (Everolimus IP licensed from BIG). BIG (in a longer way) discarded Everolimus to ABT, ABT discarded Zotarolimus to MDT. How good can zotarolimus be? No need to think too deep we also can know the answer already and MDT is still promoting their DES like saviour for the world. They are using rival's discarded drug technology because MDT don't have any other drug IPs. Zotarolimus even beat Paclitaxel drug, even worse when compared against Everolimus and Sirolimus, how to even touch BiolimusA9? It is very stunning for a small company like BIG to come out with a proprietary drug like BiolimusA9. Fat seeking properties derived from rapamycin, the most potent known anti-restentosis drug. Plus, BiolimusA9 targets exactly at where the drug need to work on (fatty plaque) and does not have a "systematic" anti-proliferative/ immuno-suppressant drug effect on the whole body (which is generally bad for the body's system as explained by P-A-E in one of his earlier posts). Freaking genius and revolutionary innovation!!!
From the p.d.f file that i posted just now, binary restenosis rate for in-stent is 13.3% for Endeavor VS 6.7% for Taxus. Thats freaking double! In-segment restenosis rate is 15.3% (Endeavor) VS 10.4% (Taxus). A DES expert once told me Endeavor's performance is like BIG's S-Stent BMS's performance. I read somewhere that BIG's S-Stent's restenosis rate is around 16% at 9 months, one of the lowest for BMS in the market. BMS normally has restenosis rate of 20 to 30%.
I'm sure Biosensors is a good company for the long run. However, as a TA person, I don't have a favorite stock so I am neutral to any counter.
This counter's short term TA charts point to a downtrend. Right now, the price is hugging the lower bollinger band. Also its Acc/Dist and Chaikin charts are still heading south. It has been like this since mid-May. Very bearish signs.
Be cautious with this one.
Have to agree with PAE and Bengster - The Endeavor IV results looks terrible.
My understanding is that physicians will probably consider the Endeavor for larger size vessels, ie those in the region of 3mm or bigger.
But, If I have to choose between Endeavor or Cypher or Taxus, and I have no other choice, It will be the Endeavor for me.
Let me explain why - If you look at all the animal data that Renu Virmani did on the 3 stents, you can actually see that at 28 days or so, the Cypher and Taxus stents still shows uncovered metal struts, and a high degree of inflammation, and Renu Virmani has shown that there is a linear relationship between the no. of uncovered struts vs stent thrombosis.
There is a very strong emphasis on endothelialisation and inflammation in the stent world today, and the cypher and Taxus is a no-no, in this regards.
However, as we know - there is the Nobori stent, bio-matrix stent and possibly the Xtent stent (This is the one for me, if I ever need a stent), and why in the world would we want to put in stents that has a permanent polymer in it ?
Above is a personal opinion, and not a qualified medical opinion. If you do need a stent, consult a doctor !
Duh. Just realised today Biosensors did test 46c and rebound a bit. Was using Chartnexus to plot, haven't update the closing price today.
Anyway, I dun really see much light for this stock at the moment, it did a runaway gap down today.
Terrible results from Endeavor man. Just look at the conclusion. It says it all.. Not even a sentence that says better or superior to Taxus. The best they can say is "Similar". Jia lat lah this stent..
The high TLR also consistent with Endeavor 3 trial. Bengster, they did highlight the late Thrombosis in one of the slides. It is 0.4% compared to 0% in Taxus .... higher than Taxus (which is a second grade stent compared to Cypher)
I think they better seriously look at buying BIG man :-) How they going to survive like that. Given a choice between Cypher and Endeavor, I would go for Cypher.
bengster68 ( Date: 10-Jul-2008 17:12) Posted:
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Actually there's a way to estimate: Fibonacci extension. But note that technique can only give an ESTIMATE. Doesn't necessarily mean once it hits that level a rebound is guaranteed.
Based on 123.6% extension, nearest THEORETICAL, POSSIBLE, PROBABLE support is 46c; Take the peak of 1.12 (0%) extend to 58.5c low (100%).
If that fails, 31.5c, 25.4c likely next supports.
elfinchilde ( Date: 10-Jul-2008 16:07) Posted:
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To each its own. At the end of the day, each person is responsible for their own portfolio.
I do not mean to contradict anyone. I basically, point out facts that are relevant. Yes, its true, most traders will have a stop loss, whether you long or short - so in practice, the loss should not be limitless, whether you long or short.
Having said all that - there is no dispute, that the chart looks bearish, and no one knows where the bottom is.
FOr info and discussion only.
Agree with Elfin on the float thing. That director already kena "FxxK" by everyone and he will not be elected again. I heard that angmoh got some "marital problems" to solve which resulted in his selling.
M&A or not all depend on LEADERS results. This is the most crucial event for this company. This event imo is even more crucial than CE. MNCs have their way to get regulatory approvals and capture market. But they need product superiority in the first place. BIG may be very small but BIG with M&A's MNC full backing will be a very potent force and will eventually become DES market leader for a long time.
I have attached EndeavorIV results. They don't look impressive at all. Also, MDT didn't highlight the late-thrombosis cases because they are even more than Taxus. I have already highlighed EndeavorIV's RCT late-thrombosis data in one of my earlier post.
www.medpagetoday.com/upload/
investor. there's a basic principle of money management in TA known as a stop loss. No technical person would ever accept a 'limitless' loss, or even a loss to zero. That's irrational logic. I believe most of the senior forumers who are techies here use stop losses of 5-10%.
Also, how high a stock can go to can be reasonably calculated by past precedence.
And for the record, i don't do shorting. Can understand the sentiments of the people vested in this counter tho. And between me being right and a lot of small fries dying; i'd rather i'm wrong and they have their chance to run.
in the end, no point talking so much. let the counter prove itself. Short term dead cat's bounce capped to 59c, longterm down is the tech call.. (any other TA person can weigh in?) let's see how high it can go to. hehe.
louis_leecs, lets see your bb prove themselves. :P (and also for the record: there are no foreign BBs in this counter.)
as an additional aside: go check out for yourselves the share float of biosensors, and calculate exactly how much profit is necessary to justify its current px. Its float is too big to be a cornered stock. It simply means it's good for manipulation.
Same sentiment... I only see short term in this one... never long term... not even mid...
redash ( Date: 08-Jul-2008 16:41) Posted:
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My apologies, 2m shares out of 1 billion share is about 0.2 % dilution.
The 2m share option probably has a higher ex price than current prices. So no danger of its potential dilution at the present moment, although I don't think a 2 % dilution will impact the share price very much.
In TA, when you short a stock, they say that the loss is potentially 'limitless', as you don't know how high it will go, but when you long a stock, the loss is limited in the sense that it can only drop to zero.
Therefore, for those who long now, maximun potential loss is 0.48 cents, if you short, your loss depends on how high the stock can go to.
donttalkrubbish:
how did i conclude that 49c was too high to buy: because the only support for biosensors in the past year was 67c. The earlier supports go back to May 2005 and Jun 2006: px of ~ 57c.
once these break, the fall is potentially limitless: No TA can show you what the lowest bottom is likely to be. Going by longterm techs at time of my post then though, it's not halfway through its fall yet.
It needs to find its natural support at whatever price that may be. The conceivable lowest support can be derived via FA calculations.
There may be a brief rebound sometime soon tho. Too oversold; though i would cap that rebound at 59c max, if even that. If louis_leecs' "angmoh remiser bb from gg" would like to prove me wrong, go ahead and ramp up this counter. All the small fries in here would be very happy to bail at a profit. haha.
But back to topic. FA facts:
options of 2,000 shares were granted to employees. this means share overhang and reduction of value to existing share holders.
if you read their AR, they are in fact a loss making company (nevermind whatever 'future prospects' they have in store: Jade, Dayen all had "future prospects" too.). We'lll simply speak on concrete facts rather than hope: EPS is negative. NAV is USD 9.48c. Means full valued 1.5x book to price is 19.3c in S$ for this baby. Even at 46c, means you're paying 3.6x book to price for this coy. (yes, i know bengster will say few people understand the biopharm industry etcetc, and i have full respect for him for the amount of info he has given. but then, my focus is not industry: i'm talking financials: who cares what industry a stock is in: when it comes down to accounting, they are all the same. Dollars and cents. Profit, or loss only.)
one of their substantial shareholders had sold stake in this coy on Jun 10.
When a coy buys up another, it goes into negative equity for the short term as you have to pay for the company you're buying.
Takeover/buyouts occur usually at 25% premium of the last 5 transacted days.
as an additional aside: go check out for yourselves the share float of biosensors, and calculate exactly how much profit is necessary to justify its current px. Its float is too big to be a cornered stock. It simply means it's good for manipulation.
Why dun they release some "smoke" of them going to license the newer technology. This will be make the potential buyer more kancheong.
bengster68 ( Date: 10-Jul-2008 15:06) Posted:
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It is not Endeavor 4, but the 4-yr results, probably for endeavor 2.
The essence of the 'new school of thought' is that a high late loss DOES NOT TRANSLATE into adverse clinical events.
Having said that, there is no comparison between Endeavor and say Nobori phase 1 and 2 (Biosensor's Licensee Terumo), where both late loss, clinical events are extremely low.