Biosensors   

Is Biosensors a good buy?

Medtronic's Endeavor failed to achieve comparable results to Taxus in terms of vessel renarrowing- a potentially dangerous complication. like that also can get FDA? based on what?

 

Not so fast: Medtronic Stent Receives FDA Panel's OK

http://sg.us.biz.yahoo.com/ap/071010/medtronic_stent_fda.html?.v=3

 

Ooi $3 where got so fast? Will slowly step up to $3. Should be something like that: 

21/10  = TCT2007 results = $0.75 to $0.78 (market still don't appreciate trial results)

30/10 = CE approval = $1.10

30/11 = NASDAQ listing plans = $1.50

31/12 = FDA IDE approved = $1.80

Takeover = $3

In between these check-points this stock will continue to have roller-coaster ride. For those investors already dizzy and vomitting, can consider getting off this wild ride at the above mentioned roller-coaster stops. I am set to ride on this stock to the grand finale ending...... $3

 

 

 

wake up lah, bu yaozai zhuo bai ri meng le.....

 

$3.00 "Fa Meng"

 

Oct 20 is saturday, market closed, ha ha ha..

Oct 18    0.63     <------ I buy 30 lots.

Oct 19 trading halt

Oct 22    3.00

LOL....

 

4th Oct: $0.72

5th Oct: $0.715

8th Oct: $0.705

9th Oct: $0.695

10th Oct: $0.69

......

20th Oct: $3.00

 

Joseph Hall
health reporter


A large, new Ontario study should calm widespread fears that drug-coated heart stents greatly increase a patient's risk of developing lethal blood clots, the paper's lead author says.

The so-called "drug-eluting" stents are actually safer when used properly than the more traditional types of medical tubes, says Dr. Jack Tu, a cardiologist at Toronto's Sunnybrook Health Sciences Centre.

"We looked very hard for evidence of harm because of the recent safety concerns ... and actually we found the death rate was slightly lower in the drug-eluting stent patients," says Tu, also a senior scientist at the Institute for Clinical Evaluative Sciences. The research was published today in the New England Journal of Medicine.

A Cleveland Clinic Foundation study released last December found patients with the drug-coated stents were up to five times more likely to develop blood clots than those with the older, bare metal versions.

But the Ontario study, which looked at 3,700 patients with similar cardiac profiles, found no such danger.

Half the subjects had received the drug-eluting stent and the other half the bare metal variety. After three years, the mortality rate for drug-stent patients was 5.5 per cent, compared with 7.8 per cent for the others.

While the rate of subsequent heart attacks was slightly higher among patients with the drug stents ? 5.7 versus 5.2 per cent ? there was a 30 per cent reduction in second angioplasty treatments.

Drug-coated stents were touted as a breakthrough in cardiac medicine when they were introduced about four years ago.

They were a refinement of the stainless steel mesh tubes used millions of times over the past 14 years to prop open arteries, typically after angioplasty balloons have cleared plaque blockages.

The drug-coated devices seep anti-cancer medications into arterial walls to inhibit the forming of scar tissue that can close the vessel. But in the absence of scar tissue, the metal on a drug-coated stent remains exposed for months, presenting a target for blood clots to form that can dislodge to cause heart attacks or strokes.

Tu says the Ontario findings likely differed from Cleveland's for two reasons. First, the drug-eluting stents were more likely to have been given to diabetics and people with thin arteries, who are at higher risk of renarrowing, or restenosis.

Everyone else ? about two thirds of people who need stents ? would be better off with the bare metal variety, Tu says.

Second, Ontario patients routinely receive anti-clotting drugs like aspirin and Plavix for at least a year after the stents have been inserted, because OHIP covers the full cost for that long. In the U.S., patients more typically spent only three to six months on anti-clotting drugs.

Dr. Peter Liu of the Canadian Institutes of Health Research says the recent concerns about drug stents have left patients scared and doctors unsure what to do. "I think the study is very reassuring."

 

Note: CREATE is the largest clinical trial conducted in China.  This trial conducted by JW Medical Systems Ltd, which is now 50%-owned by Biosensors, has reported very positive clinical results at other conferences held in China

JW will eventually corner China DES market, and other 3rd world countries like Africa, Latin America, Parkistan, Bangladesh, etc. Biomatrix will be in charge of penetrating into more developed countries.

After analysing the current situation, allow me to revise the chance of CE approval later this month to 95%. The other 5% chance of CE delay cannot be ruled out if there is outright corruption of CE despite all the extremely positive clinical trials evidence. The stock price is still behaving like BIG is a hopeless company. Not trying to induce you guys to buy, but if you are vested, i suggest you buckle your seat belt tight and get ready to experience the most aggressive chiong of BIG's history.

 

For those who will be attending the TCT 2007 in person, BIG is pleased to also highlight some of the key programs in which BIG and its partners will be featured.   A summary of these highlights are listed below:

 The Drug-Eluting Stent Summit (Ballroom C, Level 3)

21 October 2007 (Sunday), US Eastern Time

2.44 pm	The Biosensors BioMatrix Biolimus-Eluting DES program: Technical Review and Clinical Trial Updates (STEALTH, BEACON and LEADERS) - by Stephan Windecker.
2.56 pm	The Terumo NOBORI Biolimus-Eluting DES program: NOBORI-I Phase I update and a Preview of Phase II trial ? by Bernard R. Chevalier.
3.06 pm	The Devax AXXES Biolimus-Eluting Self-Expanding Stent for Bifurcations (including Left Main Disease) ? by Stefan Verheye.
3.16 pm	The Xtent CUSTOM Biolimus-Eluting Modular Stent Program (Focus on Multi-vessel and Diffuse Disease) ? by Pieter R. Stella.
3.46 pm	The EXCEL Bioasborbable Polymer-Based Sirolimus-Eluting Stent: Results from the CREATE Registries ? by Han Yaling. Note: CREATE is the largest clinical trial conducted in China.  This trial conducted by JW Medical Systems Ltd, which is now 50%-owned by Biosensors, has reported very positive clinical results at other conferences held in China.
4.26 pm	The Biosensors AXXION Glycocalix ?Polymerless? Paclitaxel-Eluting Stent: Results from the ?Real World? EAGLE Registry ? by Thomas A. Ischinger.

 Innovative Devices and Futuristic Concepts (Room 152A)

 

4.53 pm

The BioFREEDOM Polymer-Free Biolimus A9-Eluting Stent: Design Features, Animal Studies, and Preliminary Clinical Experiences ? by Eberhard Grube.

 

Please feel free to contact BIG should you have any further queries regarding this year?s TCT.  If you plan on attending the evening symposium and have not yet registered, please do so by visiting www.biolimusa9.com. You may also access the TCT website at www.tct2007.com for additional information on the conference.

*** See this stock chiong on Monday 22/10 morning. BIG's low share price now will not last for long. If CE suddenly pop out later this month, the great BIG sale will be history.   

 

Losing patience? This stock is a VC stock and a real test patience. Here is some homework for you to read. If you don't understand, then you better dont invest in BIG. How about you sell your BIG shares now and miss the CE and TCT2007 good news?

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4322b1-02-FDA-Executive%20Summary.pdf

Anyway, I have already summarised the conclusion in my earlier posts. 

 

 

Good!Good!Good!

Wait!Wait! Wait

Price,Down!Down!Down!

Jump Sea Stock!!!!!!!!!!!!!!!!!!!



 

 

 

 

http://www.biosensors.com/media/invite_tct07.pdf

All the BIG related trial results presented at TCT2007 will be focking good. Put the other DESs to shame. This time round we have LEADERS, a very large trial in case people are not convinced of small scale trials like STEALTH1, BEACON, NOBORI 1 and 2. When all the small and large trial results have the same excellent results, there is only one conclusion: Biomatrix is indeed a top class DES. No hiding of ugly facts and no changing goal posts like Medtronic. Also, we should be very close to CE approval. Better stay vested and enjoy the 50% rocket chiong in one day.    

 

 

BIG announced they going for TCT 2007.

 

same sentiments 

 

humm...just a few more weeks...sure we can wait ....

 

It doesn't matter if layman like us believe in Biosensor and buy in their share cos we will never be able to jack up the share prices with that few lots we buy. Biosensor need big time investors to bring it value up!!! This will only happen if it gets the long over-due CE certification.

 

Everybody don't dare to buy. Scared because too volatile and no zhengkay support. Traders make 1 or 2 cts run away already. People say BIG is a concept stock but there are many other concept stocks chiong like mad also. People rush in when the stock is in play. Look at Jade and Yongnam. 2 or 3 cts nobody want to buy. 50 cts everybody want to buy. Siao. Nobody can know for sure the exact date when CE will come out. I give the percentage chance of 90% it will come out later this month. If by 10 Nov still no announcement, that means heaven is not on our side again due to corruption at CE and CE kena delayed again. But when CE comes out, i believe BIG will be the highest volume stock with 50% surge on the same day of announcement. Concept stock? JW is already on the way to become the biggest DES player in China and already making tons of money. Trial results already shows Biomatrix is the best performing DES so far. Wait until CE approved plus excellent TCT2007 results announcements and this stock will be upgraded to "takeover" stock.  

 

Let's really hope Biosensor do get it's CE approved.

Having said that, why is there no sudden in-take of Biosensor share during this period of time? The price has been hovering at $0.70 around for quite sometime. Are there no investor believing Biosensor can really get the CE approved this time round?

 

U r right Mr Investor. CE do not require large scale trials like FDA. That is why initially BIG's strategy is to secure CE first with small scale trials, then with money coming in from sales of DES in Europe, apply for FDA and conduct costly large scale trials like LEADERS and STEALTH2. BIG is a very small company compared to giants like JNJ, MDT, ABT and BSX and we cannot afford to burn tons of cash thru large scale trials although BIG would love to do so asap to showcase Biomatrix's performance to the world. Large scale trials involves over 1500 patients but i believe if BIG's many small scale trials like STEALTH1, BEACON, NOBORI 1 & 2 can do very well, the large scale trials results should not be very far off mark. Likewise, if your small scale trials shows negative results, most likely the large scale trials will also show negative results. Small scale trials and large scale trial results are highly corelated. Wait until TCT2007 after they announce NOBORI 2 results and i will tabulate a match-to-match result comparing newer generation DES namely Endeavor, Xience and Biomatrix. These 3 new generation DES had conducted pivotal RCT trial against Boston's Taxus DES. From this comparision, you guys can see very clearly why i feel Biomatrix is the best DES at this moment. Forumers can lie in the forum for their own benefit but the the trial results will not lie.