Update Provided on Paxalisib Regulatory Pathway Following Type C Meeting with FDA
“We appreciate the extensive and thoughtful feedback from the FDA, which provides us with added clarity with respect to paxalisib’s potential registration pathway for the treatment of patients with NDU glioblastoma,” commented Dr. John Friend, Kazia’s CEO “We believe data from the GBM-AGILE trial, including the prespecified secondary endpoint, which demonstrated a 3.8-month OS improvement, provides evidence supporting a clinically meaningful efficacy signal that merits further testing paxalisib in this patient population in a larger, pivotal study.”
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