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    Nicole Gabreski

    Research Analyst at Piper Jaffray

    Nicole Gabreski's questions to Boundless Bio (BOLD) leadership

    Nicole Gabreski's questions to Boundless Bio (BOLD) leadership • Q2 2019

    Question

    Nicole Gabreski of Piper Jaffray asked if the company plans to use its in-house manufactured plasmid for AT132 prior to the BLA filing and questioned the potential regulatory hurdles and impact on timelines.

    Answer

    Chairman and CEO Matt Patterson explained that the current plan is to include the in-house plasmid in the license application, but they will ensure this does not become a rate-limiting factor for the BLA filing. He noted that if additional comparability work is needed, they could file it as a post-approval change to maintain the timeline.

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    Nicole Gabreski's questions to Boundless Bio (BOLD) leadership • Q1 2019

    Question

    Nicole Gabreski of Piper Jaffray asked about the clinical development strategy for AT466 in Myotonic Dystrophy Type 1 (DM1) and the company's confidence in its manufacturing readiness for the XLMTM BLA filing.

    Answer

    Matt Patterson, Chairman and CEO, stated that for AT466, the current plan is to evaluate two different approaches and select the most promising one to advance into the clinic, rather than developing both. Regarding AT132 BLA readiness, he expressed high confidence due to the consistent use of the same internal manufacturing process, scale, and facility throughout the clinical program. He highlighted heavy investment in technical operations, ongoing dialogue with regulatory agencies, and the initiation of commercial-oriented validation activities in Q4 2018 as key factors.

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