News Focus
News Focus
icon url

dewophile

11/07/06 8:29 AM

#1775 RE: bensf888 #1774

Isn't Japan one of the courtries where ATIII already carries a DIC indication?
The implication of course is that Atryn approval woudl be met with large market uptake up front
icon url

DewDiligence

11/07/06 9:49 AM

#1776 RE: bensf888 #1774

>Would a Japanese Atryn clinical study take around 2 to 3 years to enroll, complete, get acceptance, and gain marketing approval, with 2010 a likely target for revenue from Japan if GTCB partners within next half year? Maybe Japan can use data from the US and Europe trials.<

That’s a reasonable timeline, IMO. A Japanese MAA will use ATryn data from Europe and the U.S. but at least one Japanese study will be needed.