IMO from a risk / maturity perspective RAC are best to get some patients into the efficacy stage of the initial EM AML trial and then interim data analysis before initiating a trial in the US. Best to get the protocol bedded down through the first trial and get some experience treating patients at low dose before initiating a pivotal trial in the US (which will then be fundamental for future FDA approval).
I think this will also allow time for other forms of administration such as peripheral IV or oral to be completed. I suspect the existing trial could be amended with additional cohort(s) of patients to validate other forms of administration.
Ann: Race investor briefing invitation, page-16
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