Regulatory Strategy to Support Transformational Phase IIb/III

A small virtual oncology sponsor is gearing up to run a Transformational Phase IIb/III Trial in 2023.  Indication- glioblastoma (GBM).  Protocol amendment was submitted in Aug 2022, questions and discussions with FDA required.  As of Dec 2022 the sponsor is focusing on closing a funding round, after which operations will ramp up.  In addition to regulatory affairs and strategy, the sponsor intends to explore breakthrough designation in 2023.  At the moment the expected support is 1-2 hours a week however that might increase.  Project would not start until early 2023.

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