It is worth rereading the MSB ASX announcement on publishing three articles on Rem-L in GVHD: https://www.asx.com.au/asxpdf/20200525/pdf/44j2qyg8xbbqj2.pdf
As for not using a placebo group in the final study, the ethics of using a placebo on extremely sick kids are complicated. It’s great for data, but dead kids is a high price to pay. Matched patients from a contemporaneous database, while not considered as good as having a placebo arm, is a scientifically accepted practice. If preestablished evidence (prior trials, overseas approvals/use etc) is strong enough that such alternative options are likely to be sufficient, I believe it would be consider unethical by many to run a placebo arm.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-127
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