Ann: Half Year Report and Accounts (including Appendix 4D), page-104

This approval was in the medical device area which is a different FDA division to MSB. This division is a lot more “flexible” than the biologics division.

We can get some insight into what the FDA is thinking via their rejection of MSB’s BLA for AGVHD. The FDA appears to be very demanding and doesn’t look likely to approve anything without a double-blind Phase III trial that reaches its primary endpoint.

The super sad thing here is the cells really do appear to work, just not the way MSB’s management thought. With better trial design we would all have been toasting to our collective genius by investing in MSB, instead we are left with the wreckage of four failed Phase III trials.