Biotech Values

[DewDiligence]

GILD—Begs the question of why did they study the 8-week regimen at all?

They had no choice; if GILD hadn’t tested an 8-week regimen in at least one phase-3 trial, the backlash from patient advocacy groups and third-party payers would’ve been severe and likely caused economic harm.

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.

That’s a possibility that’s been discussed at length on Twitter in the past 24 hours. My view is that, when the dust settles, an 8-week treatment duration (for any subgroup) will receive at most a passing mention in the FDA and EMA labels.