G'day Alpha and skorpion,My feeling is that you are right on the...

G'day Alpha and skorpion,

My feeling is that you are right on the money. That is, the FDA approval has a large (unofficial) influence outside of it's formal sphere of influence.

On the other hand, there is a very strange phenomenon in the TB "industry". Each country seems thoroughly convinced that "their" TB is quite different from everybody elses. This is, of course, not truly the case but I guess it justifies a lot of research funds. In Europe, for example, even though QFT has CE_Mark, each European country conducts it's own tests and makes it's own recommendations.

Yes, I believe that Japan approval is imminent. Given that the new TB control law will be implemented in April 2005 and it clearly is structured around Quantiferon, it is not unreasonable to assume that approval will be in place well before that date. I will go out on a limb and predict approval before end 2004.

There is much good reading on CST available "in another place" for those interested but I should mention one thing about Japan, in comparison to other countries. Their society is quite different than ours and often difficult for us to understand. In this case however, a huge difference is the way in which something like QFT is implemented. In the US, for example, QFT has now received FDA approval and all involved persons agree that "it is a good thing". They will now go forth and progressively implement QFT as a replacement for TST. It will take some time to achieve 100% market penetration. In Japan however, they have already done all the work to convince themselves that QFT is the way to go, they have designed their new TB control program based around it and will implement it by LAW. That is all there is to it - no further discussion. QFT is the way that everyone tests for TB.

While we are on the good news (and the last few days has been full of EXCELLENT news). I have been reminded this morning about Germany. This was mentioned at the CST AGM. Germany have in the past used a form of the skin test (tine test). They have now decided that this test is ineffective and have withdrawn it's use. This leaves Germany with no available test for latent TB. CST are hoping to take advantage of this opportunity and become the one and only test for TB in Germany in very short order.

It is worth pointing out that with the recent placement, the forthcoming SPP and cash already on hand, CST have effectively $18m in the kitty. Unlike so many other bios, this money is not "because developing the product was more expensive than we thought and we need extra money to get it working, it will work this time - promise". CST have the product working, in production, approved and on the shelf. The cash on hand is to build the business - FAST. This money is to be used to market QFT and to build stocks to meet the demand. This is a lot of money and as long as the Directors don't go silly (they haven't so far) then this will hoist CST very quickly into the (minority) rank of a sucessfull Australian biotech.

Phew!