Ann: Kazia joins GBM Agile, page-31

There is a basic hollow space I reserve for my overexcitable projections that sees such potential here, so I'm going there now!

Lets do a timeline exercise for the studies in GDC-0084, but really we are looking at 2023 as the earliest possible commercial availability in my mind -

• GBMAgile GDC-0084 trial starts say June 2020.
• They are recruiting around 200 patients so give that 6 months, say Jan 2021.
• Now this trial has 2 stages from what I've read. Stage 1 PII Clinical study with 2 arms followed by Stage 2 PIII Clinical study.
* Starting from Jan 2021 the first Stage 1 PII study would take at least 12 months to get a OS(Overall Survival) readout, but then again that's unlikely as so far we have gone beyond 15mths in our Stage 1 PII MTD study!!! Anyway that's out to Jan 2022.
* Say we start the Stage 2 PIII at Jan 2022, this also requires the same ~200 patients to 'seamlessly' progress into this PIII study. By this time there should be data from the Stage 1 PII study on PFS and OS so I'm guessing within 6mths of this secondary pivotal study we will know if we have sufficient benefit to move to registration, that being 18mth to determine OS.
* That would put us at June 2022 after 18mths of testing so being conservative I believe we're talking some time in 2023 that we see the final results.

We've waited so long I would think another 2-3years, with multiple read outs during that time for the other GDC-0083 clinical trials and our Cantrixil progression to ???

With such low toxicity proven to date and reading that TMZ is given up to 6mths, surely this drug may provide benefit to methylated GBM patients beyond the limitations of TMZ!

With GBM Agile it appears we've landed a killer shot to GBM fo the greatest and quickest potential outcome. Looking forward to seeing the further details on any agreement and hopefully not giving much away...