Replies to post #179844 on Biotech Values

[DewDiligence]

GILD submits Japan NDA for Sovaldi + Ledipasvir combination in GT1 patients:

http://finance.yahoo.com/news/gilead-submits-drug-application-japan-040000790.html

Unlike the US and EU submissions for Sovaldi + Ledipasvir, the proposed duration of treatment is 12 weeks for all subgroups.

GILD submitted a Japan NDA for Sovaldi + ribavirin in GT2 patients in Jun 2014 (#msg-103797270). GT1b and GT2 comprise the overwhelming majority of HCV patients in Japan.

[DewDiligence]

Japan approves Sovaldi/ribavirin 12-week regimen for GT2 patients:

http://finance.yahoo.com/news/japan-ministry-health-labour-welfare-060000129.html

GT1b and GT2 are the predominant HCV genotypes in Japan.

GILD submitted Harvoni for approval in Japan for GT1 patients in Sep 2014 (#msg-106569334).