>>Micromet
From a purely medical perspective, given MRD-positive patients don't miraculously become MRD-negative without additional chemo, if they meet their primary clinical endpoint (based on conversion to MRD-negative), they will have demonstrated efficacy.
Whether they can get the FDA to agree, I am not at all sure. I'm sure the FDA will let them run this trial in the US as well as Europe, but that doesn't mean the FDA will necessarily agree that this qualifies as a pivotal trial.
The standard for single-arm trials is unmet medical need and no alternative approved treatment, and they meet that standard. You couldn't really blind this trial either, because 100% of the patients on the infusion get fever. So they could run something like a 2:1 randomization against "watchful waiting" I guess. Only disadvantage would be that they need a bigger trial but seems to me it would be worth it.
Peter
