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    William WoodB.Riley Securities

    William Wood's questions to Altimmune Inc (ALT) leadership

    William Wood's questions to Altimmune Inc (ALT) leadership • Q2 2025

    Question

    William Wood of B.Riley Securities asked how competitors gaining FDA acceptance for biopsy-free, NIT-based trials could create a more capital-efficient Phase 3 path for pemvidutide. He also questioned what Merck's upcoming efinopegutide data could imply for Altimmune's 48-week data and Phase 3 confidence.

    Answer

    Dr. M. Scott Harris and Dr. Vipin Garg agreed that recent regulatory developments create a 'real opportunity' for a more innovative trial design, which they will discuss with the FDA. Regarding Merck, Dr. Harris noted that Altimmune's strong 24-week data was unprecedented for an incretin and that their 48-week NIT data will be used to model and support the drug's efficacy.

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    William Wood's questions to Trevi Therapeutics Inc (TRVI) leadership

    William Wood's questions to Trevi Therapeutics Inc (TRVI) leadership • Q3 2024

    Question

    William Wood from B. Riley Securities inquired about the procedural next steps following the HAP trial data, asking if results would be immediately submitted to the FDA or bundled into a larger end-of-Phase II meeting.

    Answer

    CEO Jennifer Good and CDO Dr. James Cassella explained that the clinical study report (CSR) will be submitted to the FDA per standard timing. The results will be discussed in the end-of-Phase II meeting for the IPF trial. They emphasized the HAP study does not gate ongoing clinical programs and is primarily part of the larger NDA package for potential approval.

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