johncohen- I have a slightly different view. In my opinion- and having spoken to people who know a lot about osl- the problem was osl totally underestimating (or ignorance of) the regulatory requirements and setting up the market in 2014/2015 to believe CE was a breeze and they were in fast track. Then they realised they’d got it wrong, need to do a trial as they didn’t have enough data for CE so off they went to do panco. For a trial of that type the time it took was actually probably about par so I don’t think they were dragging their feet at that stage because you can’t always predict patient recruitment into a trial. Then of course they spent another year having to reverse the CE rejection until finally scraping through last year . But you could also say the company as it existed before the last CEO (Kenny) spent 2 years doing nothing. Or the company in England that designed the original device started development then dropped it for some reason and that’s many many years ago. so it’s a troubled path. And yes in that time other treatments have evolved.
concerning RCT you’re right, I’ve looked at their announcements from last year and $7m raised was supposed to be for US trial. But there’s no design that I’ve seen. They also told market FDA approval for pancreatic cancer in 2022/23 but you can forget that. To meet that date in my opinion they’d have needed to start RCT by 2018. And that’s assuming a positive trial. “Breakthrough” designation otherwise means little. $7million won’t get them a RCT. Depending on patient numbers (I’ve heard 200 or more) I think they’d be looking at costs at least 5 X that amount, and that’s conservative. Could be 10x. . You could go back through their financials to see how much they spent on R&D with panco to help gauge the likely costs involved with larger trial.
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