I would assume it would depend on how confident they were with the safety and efficacy profile against placebo.
Running an open label trial might be good when there is strong confidence the drug is effective and safe and further blinded data (against placebo) is not needed to progress. It is a bigger risk to take the drug to Phase 3 (double blinded) without that data because there is lot more investment and it would be disappointing if the data isn't meaningful against placebo.
In this case I think NEU have made the right call. For NNZ-2256 it was a different kettle of fish and a lot of lessons have been leant since then. The compound is different but shares a lot of the same mechanisms. From what we know it is more likely be absorbed (bio availability) so if anything, there should be less issues proving efficacy against placebo and the safety profile is fairly well established already.
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- Ann: Q3 2023 quarterly activity and cash flow report
Ann: Q3 2023 quarterly activity and cash flow report, page-17
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