Ann: ZIRCON Phase 3 Renal Cancer Imaging Study - Progress Update, page-5

It's a golden rule of biotechs that trials take longer than planned.

OK it may not always be true but you can save yourself a lot of heartburn if you double the planned timelines.

I think it's a bit ambitious to hold to the end of year for the BLA consultation. After recruitment closes, I would add on at least a month to analyse the data and put out the ann. While they're undoubtedly preparing the BLA in parallel (and filling in all of the other details) it may take a while to slot the trial data into the BLA.

If they really do get the application in by end of year. more power to them. I'm going to work on Q1 2022. We will then see how much Breakthrough speeds up the process; they were anticipating approval taking about a year.

On the trials front, the next thing it would be good to see is the Prostact trial opening up in the US. The last update we had on this in terms of the US was in Nov 2020 (the trial started in Australia in May this year). The plan was to start the trial globally in the second half of 2021 "subject to approvals".

There is a positive spin I can put on this: if they really get, say, 7 patients a week for this trial then you would hope they would repeat that level of recruitment (or better it) for Prostact. That means that they would get through recruitment in about a year, which would be great. I'm working on 12-18 months once international recruitment starts.

At the moment the company is very much pushing the main three programs (Illuccix, Zircon, Prostact) but they have lots of other irons in the fire as well. But I'm not expecting any real news until the end of this quarter.