Ann: Investor Update, page-47

You don’t include chemo costs in the equation because that’s standard of care, pc patients be getting it anyway and should be covered by public purse, insurers etc. think of device as substitute for radiotherapy, an addition to chemo. Lot of chemo generic anyway.
ce mark requirements for marketing approval less than fda which (like drug) will need phase2/3 RCT evidence which OSL says it doing. Hence 40 showing safety and performance of device ok for Ce but not enough for US. Advantage earlier to market with CE and relevant to other countries outside Europe, better chance partner but you’re right that lower level evidence makes harder sell to doctors and reimbursement agencies, and therefore slower commercialisation trajectory. .