Question · Q4 2025
Faisal Khursheed asked about any FDA interactions since the HARMONi BLA submission, specifically if the FDA's stance on the acceptability of PFS as a primary endpoint has changed, and the implications for HARMONi-3.
Answer
Dave Gancarz, Chief Business and Strategy Officer, confirmed ongoing confidential interactions with the FDA. He emphasized the company's respect for the agency and the importance of maintaining a strong relationship to advance Ivonescimab across multiple potential indications, declining to disclose specific meeting details.
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