Ann: Oncosil breakthrough device receives CE Marking approval, page-126

My 2 cents:
1. Mustn’t be ignored that BSI has given CE mark on basis of a 42 patient pilot safety study. This is bit light. We need to know what is realistic likely acceptance and convincing power of this amount of data within a medical community (and reimbursers) that is used to and may want RCT level evidence to make decisions . Can’t assume they’ll lap this up or trial data will set world alight just because it’s CE.
2. Is UK really a suitable primary launch market now. Who knows how much it and health system will be smashed by economic consequences of CoV and how long to recover.
3. good to focus commercially on developed Asia markets and Australia filings but how long do they take? Is it a given they will approve based on CE alone? Are we talking 1, 6, or 12 months for approval?
4. what are follow on clinical plans in pc.