Anavex Life Sciences Corp (AVXL)

[Joseph_K]

The FDA's previous Draft Guidance for Alzheimer's (2018) can be downloaded at
https://www.fda.gov/files/drugs/published/Alzheimer%E2%80%99s-Disease---Developing-Drugs-for-Treatment-Guidance-for-Industy.pdf

The link to download the 2024 Draft Guidance can be found here:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/early-alzheimers-disease-developing-drugs-treatment

The differences between the February 2018 and March 2024 drafts are actually quite subtle. By 2018, the draft guidance already recognized the problem of measuring progression of functional deterioration in early Alzheimer's; that did not begin with the 2024 draft. To understand the differences between the drafts and what the drafts portend for a review of blarcamesine would require careful parsing of one against the other and a good understanding of the FDA's "Stages" of Alzheimer's and in which of those Stages the P2b/3's subjects belong. Since the drafts don't reference any test numbers, like for ADCS-ADL or MMSE, it's hard for me to make that assessment.

Also, both drafts loudly announce

Contains Nonbinding Recommendations
Draft — Not for Implementation

The 2018 draft went 6 years without being "implemented" and was then replaced with a new draft. I don't know how to interpret its level of influence in the agency.