Anavex Life Sciences Corp (AVXL)

[Doc328]

Fortunately for Anavex, another drug's approval does not alter past designations by the FDA. Blarcamesine for Rett still has the Orphan and fast-track designations, the same as trofinetide had. Both also had RPD designation allowing for the voucher upon approval. Acadia had access to the rolling submission process as will Anavex.

It's noteworthy that Acadia reported topline Lavender phase 3 results December 2021 and summitted the NDA probably July 2022 (exact date unknown but FDA has 60 days to respond) and had the NDA filed by the FDA September 2022. Six months later, like clockwork, the FDA approved. Without Fast-track, it would have taken 4 more months. Thus, assuming the Excellence study had LPLV last week or this week and it clearly succeeds and if Missling can keep to a reasonable timeline, topline will be September 2023, submission April 2024, filing of NDA June 2024 and decision December 2024. They might shave one month off this but could also miss by a month or two to the long side.