Biosensors   

Is Biosensors a good buy?

Hmm.. so bengster68.. in your opinion.. de CE approval will be further delayed? Since FDA will list out another set of testing requirement.. So BIG has to re-test all over again?

 

FDA Expects to Toughen
Coated-Stent Guidelines

The Food and Drug Administration expects to issue new testing requirements in the next few weeks for drug-coated heart stents, the agency's device chief, Daniel Schultz, said.

The revised guidelines come after some researchers have expressed fears that drug-coated stents may cause serious complications. The FDA held a two-day meeting last December over concern that coated stents increase the risk of blood clots years after implantation. After a year of study, it still isn't clear whether they increase late clots, but coated stents don't appear to increase deaths or heart attacks when compared with plain stents.

Stents prop open clogged arteries to relieve chest pains from heart disease. 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 new FDA guidelines, which are expected to be more stringent than those currently in force, will probably cover items such as the numbers of patients on whom new stents must be tested and for how long. The rules may extend to the periods both before and after the FDA approves a stent for sale to the public. The guidelines may also discuss the recommended time that patients should take the anticlotting drug Plavix after getting a new stent.

The FDA's bar for approval can affect how much companies spend on studies as well as the level of certainty doctors and patients can have that stents are safe and effective.

The guidelines aren't expected to affect stents already on the market or models from Minneapolis-based Medtronic Inc. and Abbott Laboratories, of Abbott Park, Ill., that appear to be on the verge of approval.

***C.B!!! Chao Ang Mohs confirm got "kap". Just after MDT and ABT will get their approval FDA raise the bar for BIG, the next DES on the verge of obtaining FDA IDE. Why not do it before MDT and ABT as well? The blood clot problems was widely discussed since early 2006 and now then they want to scrutinise it for approval. FDA and large medical device companies operate like mafia incorporated. Continue to approve stents with late-thrombosis (Xience) and allow selling of problematic first generation DESs (Cypher and Taxus) and stop newer and better late thrombosis-free DES Biomatrix from entering the US market earlier. Focking bast#rds!!!

 

 

bengster68

Posted: 10-Dec-2007 17:06  However, removing of distributorship in certain Asia countries is not so good for BIG as this distributorship could be used as a bargaining power for BIG in case Xtent kena takeover by other medical device giant. BIG can demand some form of compensation fee for early termination from the new Xtent owner for passing back the Asia distributorship portfolio.

OCBC: The revised agreement also states that in the event Xtent undergoes an M&A, the acquiring company must pay a one-off fee on top of current royalty obligations to Biosensors to continue using its technology.

Looks like BIG got all angles covered. Well negotiated agreement amendments with Xtent.

 

Tks Bengster68.. I get wat u means.. understand that they r currently working on somethings.. Cheers..

 

Question: U did mentioned that de management of BIG (or someone sitting in there) has a brillant way to boost the unvalued shares up to its marks. Has this been done?

Answer: Yes, its in the progress. There are 2 parts here in this method of bringing up BIG's valuation. But i feel BIG is being too greedy and doing trying to do Part 1 before doing Part 2. I feel they should go directly to Part 2 because i foresee Part 1 method has very little chance of success. Put it this way, "You may be clever but that doesn't mean others are stupid" and i feel BIG don't have enough good bargining power to close Part 1 successfully. Should just forget about Part 1 and go straight to Part 2. Part 2 itself is already very good move. However, if can close Part 1 first, then do Part 2, the effect will be double. If do Part 2 now, the opportunity to do Part 1 will be lost.    

 

 

Huat Ge I also hope price will go upward,I still have some my hand.

 

oh... haha.. sori.. guess i read your sentence mistakenly..

me2.. waited since 05.. but no worries.. Santa Clause is coming to town... HoHoHo..

Hopefully de break out soon will b upward trends..

Cheers to all of u..

 

Friend I never said this is potential stock,I mention this is Hollan stock,I waited CE from year 2005.

 

This boy is going to break out soon. up or down, dunnoe, when break out also dunnoe. just put it in ur watchlist.

 

Alamak.. xiaomage888.. first.. u said tis is LP stock..dont get too close to it... then u said tis is potential stock and wait patiently for CE to obtain?? So which is which??

 

I told you before this is LP stock ,a lot of pp" Jump Sea"Dont to close to this BIG

 

This guy moves up and down like nobody business.

Really do not know how much is considered good price...

Yet to vest

 

OCBC Maintains buy raiting with fair value of $0.99:

Biosensors International Group: A better agreement with Xtent

Summary: We view Biosensors International Group?s (Biosensors) recently revised agreement with Xtent (NASDAQ: XTNT, Not-rated) from the original one entered in May 04 in a positive light. Under the revised agreement, Xtent is now allowed to purchase the actual drug and polymer (not IP) from Biosensors for use under restricted conditions but has agreed to pay more for it. The revised agreement also states that in the event Xtent undergoes an M&A, the acquiring company must pay a one-off fee on top of current royalty obligations to Biosensors to continue using its technology.

However, Biosensors will give up its right to exclusively distribute Xtent?s products in certain Pacific Rim countries as it chooses to focus on developing its core technology. We retain our forecasts that Biosensors should have positive regulatory news in Jan-Mar 08. Maintain BUY and fair value of S$0.99.

 

Hi Bengster68.. i recall in one of your postings.. u did mentioned that de management of BIG (or someone sitting in there) has a brillant way to boost the unvalued shares up to its marks. Has this been done?

 

Nobody bought BIG's shares because they have distributor rights for selling Xtent's DES in certain Asia countries. Nobody even knew BIG has this Xtent distributorship. So terminating the distributorship is inconsequential, except possible compensation from takeover buyer of Xtent (if it happens). I don't think BIG can make much from this distributorship anyway since asia countries are normally slower to adopt newer techniques. BIG should focus on things that are of greater importance rather than being a jack of all trades but master at none. Also, Xtent's CE will be after Biomatrix so their possible launch date would be end 2008 or early 2009. However, doctors are very new to Xtent's very unique delivery system and it may be quite hard to market this DES system here anyway. Generally, doctors are lazy and they always prefer stents that are easier to deliver so they have lesser professional liability in case they screw up the angioplasty. Xtent's delivery system is more complex and require more doctor skill. I read somewhere that Xtent's Delivery gadget looks quite huge, complex and intimidating initially but after practice, it is actually user friendly. But Xtent's system is very innovative, cost saving (if you need to implant 2 DESs at one go) and cutting precise DES length technically should be better for the patient and its also very good for implanting a super long DES.

 

1.  The issue / listing of 5 mil Biosensors shares today forms part of the Purchase Agreement with PT Fondaco.   PT Fondaco is still bound by the Agreement not to sell / dispose of the issued shares for 12 months. 

2.  With regards to the amended licensing agreement with Xtent, that has been properly analysed and explained by Bengster.

Nothing to get excited or alarmed about with the announcements by Biosensors today.

I guess we will only sell the takeoff for Biosensors when the CE Mark is approved. 

 

BIO extra shares listed today.... surprised to see the announcement came EOD although shares were listed today morning at 9.00... something doggy happening....

"Listing And Quotation Of 5,000,000 New Ordinary Shares Issued As Partial Satisfaction Of The Purchase Consideration Pursuant To The Acquisition Of Business Of PT Fondaco Mitratama" listes


Also in the previous announcement, something is of REAL concern....

"The exclusive rights for Biosensors to distribute XTENT?s products in certain Pacific Rim countries that were included in the original agreement had expired and are not included in the revised agreement."

This is definitely going to affect BIO prospects.... better stay away for now.... 

 

great to have u onboard.. soon... and hope u ready to strike on the bull eye like u did for frontlier..

Cheers..

 

 

looking to enter Bio again. soon prehaps..

 

Better profit margin for BIG from selling of Biolimus drug and PLA biodegredable polymer, lesser servicing costs and liability from taking care of Xtent's coating, testing and other support services. These 2 points are beneficial for BIG. However, removing of distributorship in certain Asia countries is not so good for BIG as this distributorship could be used as a bargaining power for BIG in case Xtent kena takeover by other medical device giant. BIG can demand some form of compensation fee for early termination from the new Xtent owner for passing back the Asia distributorship portfolio.  BIG owns 5% of Xtent plus 5% option to subsribe at a low cost. BTW the 5 % option can worth a lot also if Xtent kena takeover. On top of selling drugs and biodegredable polymer to Xtent, there are milestone payments for technology transfer and royalties from sales after regulatory approvals. These are probably P&C and not known to public. Xtent's CE will be after BIG's so i makes sense to do minor adjustments to the date as both parties probably didn't expect CE to delay until almost 3 years because CE only takes 1 year for other stent approvals, including Costar, Taxus Liberte and Endeavor Resolute. Chao Ang Mohs confirm got "kap".