i actually don’t disagree with you. For CE they’d have...

i actually don’t disagree with you. For CE they’d have demonstrated compliance with standards for safety, manufacturing and performance of device, and with poor outlook of disease to be treated got the green light. No problem there, all good. I’m unaware of CE requiring to show your device is as good as or better than anything else. My hunch is how the device stacks up against what is current practice/evidence in LAPC is what medics and reimbursement committees will really want to know. I’ve read OSL plans to charge high $$$ per dose (and I’m guessing that doesn’t factor in the extra procedure and personnel costs a hospital has to incur to use device) so they’ll need compelling evidence to convince it’s worth it. I’ve no doubt though some wealthy private patients with PC may want to get it if they can find someone to implant it but don’t imagine that’s a big market in EU? . I get there has to be some hype in this game but some of the stuff you read about this device beggars belief eg Bell Potter report of April 20: the data are “overwhelmingly one sided” in favour of Oncosil - my response is bovem excrementum maximus as they say down my way.
All IMO.