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Replies to #38160 on Biotech Values
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gofishmarko

11/28/06 5:29 PM

#38164 RE: DewDiligence #38160

>> Could it be that they will file
for approval of the 3-dose regimen in Asia while
aiming for a 2-dose regimen in the West? <<

I bet it's something like that. For the first P3 , it made sense to do a head-to-head 3-dose comparison study , and in many countries this single trial may be sufficient for registration. In the EU and US they'll need a 2nd trial , and they may as well go for the 2-dose regimen as it will be an added marketing tool. The just completed trial will be supportive of the upcoming P3 using only two doses.