Thanks for reply—I think I see the source of the discordance. Each dosing cohort was blinded as to the assignment of patients to drug vs placebo; however, as is typical in a phase-1 dose-ranging study, the cohorts themselves were open-label. I.e. the cohorts were filled in series rather than in parallel and the sponsor had access to the data from a completed cohort before deciding whether to launch the next cohort. In such a trial, the sponsor can be sitting on a lot of valuable data before the trial ends, which is what tony’s question was about.
I erred in saying that ITMN had access to the data in real time. I should have said they had access to the data at the end of a cohort.
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