Well, like I always say, everything in biotech takes longer than you think...
and, like I've also said, Telix is often feels a bit contrary because some things have gone quicker than expected ($US500m annualised revenue in 7 years!!) whereas others have gone slower (like trials and FDA submissions).
Let's look at 250 specifically.
The company launches 15/11/2017.
The ZIRCON trial is filed on 23/08/2018
The ZIRCON trial commences on 23/10/2018
They reported a successful pre-IND FDA meeting on 20/07/2019
The first Australian patient was recruited on 20/08/2019
The FDA IND was submitted on 24/12/2019
The IND was approved on 23/01/2020
Then COVID hit.
EU ZIRCON recommenced 20/06/2020
US Zircon commences 25/01/2021
Update on 20/07/2021 saying recruitment will complete in 4/5 months
ZIRCON completes on 08/03/2022 (but continues recruiting)
ZIRCON recruits 300 in total and ends 11/07/2022
Zircon reports on 07/11/2022 with excellent results.
The BLA is submitted 19/12/2023
The BLA is completed 03/06/2023
The SNAFU emerges 31/07/2024
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So that's a long slow journey, yes? It will be a (hopefully only) a bit over 7 years since the company started and the FDA (we hope) gives approval.
So where did the time go?
* It looks like they had to get ZIRDOSE done and dusted before they could start ZIRCON, that looks like it cost a year.
* It looks like they lost at least 6 months, maybe more like a year, because of COVID.
Still, superficially, yes even five years looks a bit slow....
Now if Zircaix and Pixclara were the only things the company had done in the last seven years, maybe I'd be drumming my fingers with annoyance. But, in the mean time, there's this product called Illucix which is doing fairly well....
But it's worth remembering, Telix was originally a small company. There may have been limitations in the amount of resources available to throw at things like submissions. As it became clear that Illucix was going to be the early win, maybe resources were thrown at that. Maybe, even now, there's a limit to how fast they can go preparing FDA submissions because it's so specialised and it's not like you can just hire 50 people to speed it up.
All I know is, I'm not complaining about how things are going because things are going very well since I bought in. I do think it's worth keeping an eye out because history may at least rhyme when it comes to Prostact Global.
Then again, maybe Telix realised that historically, execution speed has been a limitation for them and may hold them back in being first to market for future products. Maybe they thought that, you know, raising a whole heap of cash might help them. By the way, did you notice how much emphasis the company gave on demonstrating how much return on investment they were getting on their R&D spend?
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