JG:
“This award of ODD concludes a program of regulatory optimisation that Kazia
has initiated for paxalisib over the past six months. As we orient paxalisib towards
commercialization, these special designations from FDA will allow us to move forward in the
swiftest and most effective way possible.”
"Kazia expects to present further data from its ongoing phase II study of paxalisib in
glioblastoma at the Society for Neuro-Oncology (SNO) Annual Meeting in November 2020.
Initial efficacy data from the ongoing phase I study of paxalisib in DIPG at St Jude Children’s
Research Hospital is expected during 2H CY2020. Precise timing remains uncertain due to
pandemic-related disruption in conference schedules, but Kazia expects to provide an update
to investors at the earliest opportunity."
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