efficacy and safety outcomes in earlier clinical trials that were similar between HLA-A*0201–positive and HLA-A*0201–negative patients21 (and unpublished data)
The argument of the must-put-the-protocol-in-the-label group has at least some merit in that even if the above is true it is also true that those trials must not have demonstrated efficacy (e.g. been to small - so how can there be a claim of same-ness between HLA-A2+/-).