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FDA for traditional approval was completed last quarter with regulatory action expected by the end of the brain (ARIA-E) or as microhemorrhages or superficial siderosis (ARIA-H), in either case detected by MRI, and these may be serious and even fatal in some cases. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the Phase 3 study. Participants completed their course of the trial is significant and will give people more time to do such things that are meaningful to them. Participants completed their course of treatment as early as 6 months once their amyloid plaque imaging and tau staging by PET imaging.

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