Anavex Life Sciences Corp (AVXL)

[boi568]

Here's the most useful point Grimmer made:

"The trial inclusion requirements were readily manageable for both the patients and the families with no mandatory invasive assessments. The emphasis was on the National Institute on Aging (NIA)–AA criteria for diagnosis of early-stage mild-dementia due to AD."

The EMA stated in November 2024 that "NIA-AA sets of criteria are accepted by the EMA guideline on clinical studies for AD medicines in effect since 2018."

https://www.ema.europa.eu/en/documents/report/alzheimers-disease-eu-horizon-scanning-report_en.pdf

So the 2b/3 trial, as described by Grimmer, is considered by the EMA to be an early-stage AD trial. These facts document Anavex's position that the EMA does not require the company to meet its ADL co-primary endpoint in the MAA now being evaluated.