The proof that the interim analysis and unblinding did not take place is the reasoning, unblinding the trial might jeopardize impartiality and insert bias. The trial was not unblinded at the scheduled interim because unblinding would have had the effect they wanted to avoid. How hard is that to understand?
In looking for accelerated approval under a 5052b, the FDA would pounce on an interim unblinding and likely require a statistically reliable Phase 3, maybe even 2 of them. They would even cite possible investigator bias if the results were too good.
I’m not buying the poor results/failure argument at all. It makes more sense that raw, blinded data showed stronger results than expected. Then Leo and officers would want to protect the study integrity from criticism by canceling the interim.
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