Is it expected than an additional study will be required, either subsequent to or in parallel with GBM AGILE, in order to achieve regulatory approval?
No. It is anticipated that GBM AGILE will serve as a single pivotal study for registration of GDC0084. Kazia may nevertheless consider other clinical trial opportunities in due course to expand the potential use of GDC-0084, but it does not anticipate that another substantial evidence study would be on the critical path for regulatory approval in glioblastoma.
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