I don’t think they need to Wasa. Phase 2 trials are primarily about ensuring the safety profile, with secondary outcomes measuring efficacy and the like. These can be small number trials, possibly even as small as 6 patients. If safety concerns allayed then they can move to a Phase 2b trial to test dosages. Only in Phase 3 will many participants be required to ascertain statistical significance. With that in mind it’s certainly possible the Phase 2a trial can be run relatively cheaply.
Focus now on NNZ2591, page-25
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