On 2 May 2019, we released updated results for our DARRT-1 study, wherein we presented the 6-month data for the dose-escalation arm of the study.
Those of you who have been following our journey for a while would have noticed a change in our approach. Specifically, we limited the disclosure to top-line clinical data. There are two reasons for this. The first is that this is standard procedure in the pharmaceutical industry – the key outcomes are released publicly, and the details are submitted for peer-review by an academic society and possible presentation at their annual scientific congress. In fact in many cases, the public release of even top-line data is held back until it has been peer-reviewed. As a company with ambitions to become a serious player in this industry, it is only appropriate that we conform to this standard.
Which leads to the second reason, which is that we plan to present the detailed data to a scientific conference in the coming months. This peer review mechanism is critical for establishing the credibility of our work on the local and global stage and is of paramount importance in the development of any drug. Peer review provides assurance of quality and is a fundamental requirement to achieving acceptance and visibility of our data within the scientific community and with regulatory authorities such as the U.S. FDA and Australia’s TGA.
The aim of the recent announcement was to provide the market with the key clinical outcomes and to frame them in terms of what they mean for the future development of Veyonda®.
The downside for those of you who, like me, love the detail in the data, is that we must wait a bit longer to interrogate these finer details. We must wait because prior disclosure (beyond what we disclosed in our announcement) will result in rejection of submission to these societies under the principle that the data is not new (it has been disclosed already).
Peer-review builds credibility and good results build excitement. It would thus be remiss of me not to reiterate how excited we are with the data we shared on 2 May. I am immensely proud to lead a company that has played a hand in helping these men. Our team is committed to bringing Veyonda into everyday clinical use, because helping as many people as we can to put cancer on the sideline is what Noxopharm is all about.