Chad Yahn's questions to RenovoRx Inc (RNXT) leadership • Q2 2025
Question
Chad Yahn, on behalf of Jason McCarthy from Maxim Group, asked if RenovoRx has engaged with the FDA regarding a potential accelerated approval pathway for its therapy. He also asked how the 16-month median overall survival from the first interim analysis compares to outcomes from similar trials.
Answer
Shaun Bagai, CEO & Director, responded that the company plans to engage with the FDA about a potential accelerated approval pathway as they get closer to final data and prepare for a potential New Drug Application (NDA). He contextualized the clinical data by explaining that the control arm's survival rate fits squarely within the 14-18 month range seen in contemporary trials for locally advanced pancreatic cancer, such as Novocure's PANOVA-3 trial, suggesting the bar for showing a meaningful clinical benefit is well-defined and achievable.