Replies to post #173453 on 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.

[nidan7500]

Talon38

this is a very important FDA Guidance Document on AD and should be in the final phase of publication given the Feb 2018

I might say that was excellent planning by Anavex

Yes Talon I agree. Also note this publication timing roughly fits w/the withdrawl of almost every BP from the Amyloid Thesis baseline trials. Some of us are still wondering how/why that happened after decades of massive spending and clinical effort. Maybe now we know, even as we suspected that a birdie whispered to BP that they need to get to work on PM and use more science and lab work to find and evaluate BIOmarkers for AD.
[quoteSuch an effect, analyzed as a primary efficacy measure, may, in principle, serve as
231 the basis for an accelerated approval (i.e., the biomarker effects would be found to be reasonably
232 likely to predict clinical benefit, with a post-approval requirement for a study to confirm the
233 predicted clinical benefit).]