Question · Q3 2025
Edsur Dara asked what insights the FDA meeting minutes might provide regarding the type of BLA resubmission required and the potential review timelines once the BLA is refiled.
Answer
Akshay Vaishnaw, President of R&D, explained that the minutes are expected to reconfirm the impressions of Novo's progress and the agency's commitment. However, he noted that the FDA's practice is not to spell out review timelines for resubmissions in the minutes, but rather to await the BLA filing before determining those specifics. He reiterated the agency's supportive and urgent tone.
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