The successful completion of the Phase III work that’s currently underway is the first step. The second step is the preparation of registration documentation from the results of that study, and the final step is approval from the Japanese health authorities to market the drug in Japan. If the product is to be commercialised beyond Japan, those steps will need to be repeated in other markets such as North America and Europe.
The target was the Japanese seasonal flu market. It is about 8x the US market
However if the flu became resistant to Tamiflu and/or relenza, they may push things through. It would have to be a political decision, the FDA and European equivilant would not stick their head out on this one.
Still looking for the rest of the info.
M
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