it needs to be new patients because safety and efficacy readings will be different if you've previously had the therapy.
Also, if you just keep the same patients from cohort 1, then you would only have 4 subjects in your subject population for this study. They need more than that and I think they're estimated recruitment from their clinicaltrial.gov listing is 36 patients.
This Phase 1 trial will open the door to a compassionate access scheme, so people in cohort 1 and/or 2 could access the best dosing scheme if it is clinically beneficial. Note that they will be in the trial up to 15 years as specified in their protocol.
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