It's true that my numbers might be considered conservative....

It's true that my numbers might be considered conservative. However, if I was Jon Symonds, I'd also be taking a conservative view particularly given the rubberiness of regulatory reviews, where clock-stops can add months to a review process.

As for whether the Japanese government might subsidise MSB to more than the market actually sees: that would be, in my experience, unique. Most subsidies are built into the negotiated price with the company, much like our PBS. Occasionally, companies get subsidies, often in the form of tax breaks, for things like local manufacturing or R&D. I've never come across a direct subsidy not built into the price.

The lower costs of hospitalisation is an interesting question. A lot of people with refractory GVHD die, meaning that they are, in cold, hard pharmacoeconomic terms, very cheap. Keeping them alive will almost certainly turn out to be more expensive, which is when things like QALY's start to get measured, and priced.

As for efficacy - indeed, the product may be successful. It wasn't in the last round of Phase 3 studies in the same indication, carried out by Osiris. We might expect that MSB looked and learned from those studies, and altered the design. However, if there's an inherent weakness in the product, trial design may not overcome it.