Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: How are you planning the Phase 3 HCV trial design, especially regarding adherence issues and the use of an active comparator? What are you seeking clarity on from the FDA? A: We plan to conduct randomized trials to address adherence issues by having a control group. Our Phase 3 development plan aligns with FDA guidelines, and we are confident it will be acceptable to the FDA.
Q: Have you observed any changes in the pharmacokinetic (PK) profile of the fixed-dose combination compared to individually administered drugs, particularly in terms of half-life? A: No, we have not observed any changes. The PK profile for both drugs remains consistent, with no differences in drug exposure or half-life.
Q: Will the Phase 3 trial use the same doses as Phase 2, and will there be more US sites involved? A: Yes, the same doses will be used, but now in a fixed-dose combination to reduce pill burden and improve adherence. We will have significantly more US sites in Phase 3 compared to Phase 2.
Q: For the Phase 3 trial, are you aiming for superiority or noninferiority in terms of SVR12? A: The trial will be powered for noninferiority, with a secondary test for superiority. We anticipate a 5% noninferiority margin, with a sample size of about 800 patients.
Q: How do you view volume-based contracts in the market, and how might they impact your sales strategy? A: Volume-based contracts, especially with government entities like Medicare and Medicaid, are significant. The market is concentrated, making it efficient to target key prescribers, and we expect this framework to remain stable.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.