June 2019 "What are the next steps in the GDC-0084 program? We should mostly finish the ongoing phase IIa study towards the end of this year. We are already
well-advanced in preparation for a registrational study that will hopefully start in the first half of 2020. This will likely involve around two hundred patients and will take a couple of years, which is a very quick path to market by the standard of most cancer drugs.
We have a lot of clinicians who are very keen to be a part of the registrational study, so it will be exciting to see it come together!" (Dr Jeremy Simpson Clinical Program Director )
"The number of patients in the US is also an important consideration, given its large population. As we move towards registration for GDC-0084, we plan to include hospitals in additional countries, including of course Australia!"
"We adjust our indicative valuation range to A$84–135m or A$1.35–2.17/share (vs A$84–146m, A$1.36–2.34/share), due to revised timelines for post-Phase III approval or single-pivotal-study approval scenarios for GDC-0084. Kazia had A$5.4m cash at 31 December 2018 and will likely need to raise funds in H219. We estimate ~A$15–20m will be needed to fully fund the GDC-0084 Phase IIb study."
https://kza.irmau.com/irm/PDF/2077_1/EdisonResearchHigherMTDnewcollaborationforGDC0084
All the above information has been well advertised for well over year. The trials for the other collaborators are going ahead regardless of the upcoming CR and first efficacy data.
The success of KZA rest largely on the up coming data. But if one listens to the language of the company coupled with the commitments of the world best clinicians for their trials, plus the plain and simply honesty well advised in the edison report highling the risk of dilution and he cost needed (20M) one can clearly see the path forward and what will be required. Is it worth the punt. Ironcial it was Paul Hopper who was one of the first to say yes. Although he is now out of the picture, to which I am so limited as to what can be said, it nonetheless clearly show the risk to reward was considered reasonable good. And nothing has changed other than the lost time in the MTD side of the trial. Yes a small set back in time and cost but now a more higher chance of success. And there you have the clash of conservative slowly as it goes approach of JG and team vs the more aggressive push it through style of the first designed trial. Wink wink.
My point in all this is simple the drug has not changed. The MTD is now better. FDA requirement are now more realistic. The down side is the lack of money and timing of the CR due to time spent on the part A study. The upside the pre efficacy study of the expansion cohort of 20 has been funded by a much small pre/funding from last year at a very small dilution. The now larger funds will be based on solid fact not hope, and will give investors a fairer and clearly picture of what is ahead. Conservative yes, but frankly IMO much more ethical and realistic. If it had gone ahead the other way, investor would have been asked for the same amount money now required but with no pre-efficacy and completely blind . Some charismatic types are great at raising fund that way. But this way funds will be raised on substance and fact not flair.
In nutshell, the coming registration trial will be done with much more transparency honesty and ethics.
