Anavex Life Sciences Corp (AVXL)

[Talon38]

Why our input to the ACTC is extremely valuable:

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From the AD Regulatory Guidance document"

Precompetitive structured
244 sharing across the AD scientific community of rigorously collected standardized data is a crucial
245 component of this research. While research pursues the development of evidence sufficient to
246 support the use of biomarker measures as the primary evidence supporting an accelerated
247 approval, or perhaps a full approval if the fundamental understanding of AD evolves sufficiently
248 to establish surrogacy, a possible approach to Stage 1 patients might be to conduct a study of
249 sufficient duration to allow the evaluation of the measures discussed above for Stage 2 patients.
250 As patients transition to Stage 2 during participation in the trial, the principles applicable to
251 outcome assessment for Stage 2 would apply.