Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: For the Norovirus program, can you provide more color on the additional details requested by the FDA, and how do you anticipate the design of the Phase 2b trial will be in comparison to prior Phase 2 studies? A: The FDA is reviewing our pre-clinical and clinical norovirus data. We are not providing detailed information on the nature of these discussions as they are ongoing. The impact on the Phase 2b trial design will depend on the outcomes of these discussions.
Q: What steps remain to initiate the Phase 2b COVID study, and what additional information is needed from the FDA before getting their approval to start the study? A: We continue to have productive dialogue with the FDA and have addressed some comments. We have completed preparations of our manufacturing processes and have sufficient vaccine supply. Key activities include trial site activation and subcontracting with vendors. We will provide updates as warranted.
Q: Once the Phase 2b COVID trial initiates, describe the subject enrollment process. What challenges might you face in recruiting 10,000 adults for the study? A: We view this as an opportunity for our clinical trial management team to demonstrate recruitment capabilities. The study demographics will represent the U.S. population, with 25% of participants at high risk for severe COVID-19 disease.
Q: What was the $64.7 million payment for, and what milestones do you need to achieve for the COVID Phase 2b study to earn additional funds from BARDA? A: The $64.7 million payment was for achieving a milestone in the ATI contract by executing a contract with the CRO. Remaining funding is not tied to specific milestones but will be reimbursed for costs as we prepare and execute the COVID-19 Phase 2b trial.
Q: Is there reason to believe your norovirus vaccine is more robust against emerging norovirus strains, and how do you position yourself in the norovirus landscape? A: We believe generating a mucosal response is critical for an effective norovirus vaccine. Our candidates demonstrate both serum and mucosal responses, which may allow us to be more successful. Our focus is on healthy adults, not infants, which differentiates our program.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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