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Re: Doc328 post# 508526

Sunday, 11/16/2025 3:49:48 PM

Sunday, November 16, 2025 3:49:48 PM

Post# of 516446
In retrospect, the MAA was the strategic mistake. The real opportunity to start a proper Phase 3 was back in 2023. Dr. Jin was hired, but instead of moving straight into designing a well-powered pivotal trial, the focus shifted to re-analyzing the AD-004 data and declaring it a success through gatekeeping/multiplicity — more to salvage the narrative than to build a regulatory path. Then Dr. Sabbagh was brought in and the message shifted again, suggesting the OLE could somehow support approval. Once the decision was made in late 2023 to proceed with an MAA, everything that followed was basically locked in.
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