Any progress in marketing in UK?, page-11

You’re reading far too much into the TGA issue. The reason osl would have withdrawn is almost certainly because they were going to be failed/rejected. The reason they were going to be failed is because it’s clear the tga weren’t going to accept a study like Panco. So it’s better to withdraw than have the black mark in the public domain of a negative decision from major regulatory agency. Regulators don’t have to follow a common set of rules across the world. BIS eventually accepted Pancor for approval in their jurisdiction , TGA (likeFDA) won’t.

also need to stop linking lockdowns and vaccine roll out to the device performance. yes It’s hindered things , access to hospitals, but do people seriously believe that all 5000+ New LAPC that will have happened in UK since CE awarded last year (OSL’s market research numbers) just sat at home and did nothing? What the market is seeing is the challenges of trying to commercialise a product that has too little data supporting it where the decision makers (doctors) are typically data- driven.

clinical trials .gov still has osprey registry as not yet recruiting which isn’t good sign.

as for HDE bile duct cancer, by my calculation that looks to be at least 6 months behind schedule so gotta wonder if it’s really going to pass. AIMO.