US after hours markets all closed...being a Monday. Bit of a shame.
KZA management have previously meet personally with Christopher Tinkle and Amar Gajjar, from St Jude. Its the KZA drug trial St Jude ......of course, management would be fully briefed on progress. Highly significant therefore, that Kazia would specifically approach the FDA in recent times, seeking a special arrangement with FDA.
If the drug was not performing well, obviously no such discussion would take place with the FDA. I am going to call it DIPG St Jude Trial - successful, although does not take much to work that out, seemingly.
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"The St Jude study is led by Dr. Christopher Tinkle, Assistant Member in the St Jude Department of Radiation Oncology, and Dr. Amar Gajjar, Chair of the St Jude Department of Pediatric Medicine and co-leader of the Brain Tumor Program.
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12 Sept 2019
Dr. Christopher Tinkle, co-Lead Investigator on the study, commented, "to date, thirteen patients have received GDC-0084 in our study. We have determined a maximum tolerated dose (MTD) in the pediatric setting of 27 mg/m2, which we would expect to be approximately equivalent to the doses currently being explored in adult studies. The safety profile of the drug in children appears to be broadly similar to that in adults, and we have encountered no unexpected findings in this regard. It would be premature to draw conclusions regarding potential efficacy, but we now embark on an expansion cohort to explore the clinical effects of the drug in this patient group. My colleagues and I are very pleased with progress and look forward to reporting further data from the study."
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