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).]
We have also heard Dr.M say .."we will understand why he is doing what he is doing ...eventually"There is a lot going on behind the curtain I would like to think AVXL has had some influence on FDA guidance/thinking but will wait to see how this works out. It sure does look like AVXL has a head start by linking PDD-RS and AD. Nice Very good planning indeed.
