Ann: Oncosil breakthrough device receives CE Marking approval, page-80

Unfortunately though we'd like to see some dramatic increase in survival median estimate, I'd suggest that's unlikely Gekkowolf.. That's not really how survival statistics work as I think others on this forum have pointed out before. Patients don't all start a clinical trial at exactly the same time. They will be required to show the level of error too around this estimate- small study, likely biggish error. 16.1m is respectable for sure, but not really that much better if you look at more recent published trials of various therapies in locally advanced PC (that is, within the last 3-4 years) which is the segment of pancreatic cancer they appear to have been approved for by BSI (about 30% of total PC market).

I'm wondering if there will be an investor briefing call any time soon? There are some unanswered questions here. Specifically what commitments has the company made to BSI regarding post marketing trials. This was absent from their announcement yesterday but formed an important component of their submission. If investors cut through the verbiage in the CE announcement, really what OSL has achieved is it has met a minimum safety/performance directive for its device. The market needs to know what follows. What is the plan for a pivotal study in pancreatic cancer? And I still cannot find any evidence anywhere of BSI giving "breakthrough" classifications!