Replies to post #171503 on Biotech Values

[mcbio]

Re: Timing of EU approvals for GILD/ABBV HCV combos

I know U.S. approval for the GILD/ABBV all-oral combos is generally expected late 2H14. What is expected timeline for EU approval? Is it the same?

[ciotera]

I don’t think GILD wants to open the door to receiving less revenue per patient from 8-week treatment durations.

Begs the question of why did they study the 8-week regimen at all? If it was at the request of the FDA, then they may not have the option - it'll be part of the NDA package and the FDA may choose to indicate it as 8 weeks for naives.