Thanks for the well thought out response. Just a couple of points.
Prior medications are not really considered confounders if there is an appropriate washout period. While prior medications can have a delayed response, if a patient is considered to be a non-responder and/or if they fall into the high-risk category where mortality is 80% after 100 days then I find it difficult to see how prior treatments can influence the outcome variable. The only confounders the FDA adjusted for were withdrawals, those who received concomitant medications and those whose symptoms improved prior to treatment.
I understand there are potential or unknown confounders which in totality could influence the outcome variable, hence the reason why I think any future trial must be randomised, I’m just trying to rationalise whether it must be placebo controlled and double blinded or if it can instead be an open-label trial. It definitely won’t be a single arm trial given that Rux is approved for adults. It must also have an adequate control.
I also noted your interpretation of the MAP results. After taking a look I found the MAP results to be surprisingly very difficult to interpret. To begin, the MAGIC cohort consisted of a lower percentage of clinically severe (grade III/IV) acute GVHD than the remestemcel-L group (16/27 (59%) v 20/25 (85%), p=0.02). The MAGIC cohort also consisted of patients with substantially lower starting MAP levels than the Rem-L group, which when you take into account the following groups: Ann Arbor 1 is defined as MAP < 0.141, Ann Arbor 2 as 0.141 ≤ MAP ≤ 0.290, Ann Arbor 3 < 0.290 – each group has a different overall survival duration. Ann Arbor 1 and 2 groups require comparisons of overall survival at 2, 3 or 4 years, not 180 days. Based on this, while it is certainly possible, it is currently not clear that Rem-L has no apparent benefit when the MAP score is below 0.29. It has no benefit after 180 days, but this time point should only be used for those with a MAP score > 0.29.
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