Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide expectations for the KDO and Tori trial in second-line lung cancer, given some recent competitive challenges? A: Dennis Lanfear, CEO, and Rash Dias, Chief Medical Officer, explained that they are building on promising data, including rare monotherapy partial responses in PD-L1 refractory subjects. The bar for second-line treatment is low, with standard care being docetaxel alone, which has a low response rate. They plan to proceed with a phase three study if results are favorable.
Q: When will ICCA be available in the commercial channel again, and how have accounts managed without it? A: Paul Reider, Chief Commercial Officer, stated that sales are expected to resume in late November to early December. Some accounts managed with existing stock, while others switched to alternative products. Many customers have assured they will return to ICCA once available.
Q: What is the expected response rate for the CZ Dozo trial in late-line lung cancer, and what benchmarks are you using? A: Rash Dias, Chief Medical Officer, noted that the baseline response rate for docetaxel is around 12%. They are looking for an increment over this in their trial, which follows a standard Simon two-stage design.
Q: At what point do you expect to meet all demand for ICCA in the marketplace? A: Dennis Lanfear, CEO, mentioned that they plan to produce 120,000 units in five weeks, which should meet several months' demand. They expect to have all products in the market within three to five weeks.
Q: Will there be an even restocking of ICCA formulations, or is there a priority? A: Paul Reider, Chief Commercial Officer, indicated that restocking will follow a sequential flow, starting with the on-body device, followed by pre-filled syringe and auto-injector. Once initial restocking is complete, all formulations will be available in the channel.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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