Of course I have, but to get to a Phase IV confirmatory trial you actually have to have a Phase III trial that at least meets a proxy primary endpoint that the FDA accepts. MSB have three Phase III results which failed to meet their primary endpoint (due to poor trial design in my opinion, but that is another discussion), and one where the FDA didn’t accept the trial design was appropriate (AGVHD) at the approval stage. It is back to Phase III for MSB.
Ann: Half Year Report and Accounts (including Appendix 4D), page-92
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