This is another reason GILD should own their shortcomings in GT3. The Sofosbuvir/Daclatasvir oral combo demonstrated 100% SVR24 rates in GT2/GT3 patients (Phase 2 / n=14). Norbert continues to downplay expectations for Sofo/GS-5885 in GT3 but it should be noted that the failure here is GS-5885 not Sofosbuvir or the NS5A class.
This can be handled one of two ways. GILD can meet with the FDA and suggest stratifying data between genotypes and filing separately (or not at all in GT3) or the FDA will make them do it.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.