Replies to post #115398 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

As with all Anavex topics, one must think big; and now, broad, across the entire world.

IMO, there is an important-subtle change in addition to WW regulatory body rethinks. They (Dr. M.) are saying (IMO)..."this is all about the process". Compared to pass fail/event driven/good bad passed trials.

In AVXL case (I pray this is true) we claim A2-73 (others to follow) is capable of restoring CNS cellular function (Homeostasis). Pre clinical trials and our studies indicate the story is true and the efficacy of the process certainly will be shown. We are developing dose models, but the basic process should be effective. The degree to which this thesis can be proven/demonstrated/studied/evolved/improved remains to be seen. IMO, Dr. M. and team are on the point demonstrating and validating the process. He acts like if we just follow the process we will get the results we are looking for. If he is right then variations of CNS restoration thesis will certainly evolve quickly.

So, the new international trial rules will rely less on sample size and statistical analysis and more on adaptive learning using new tools/methods to validate the concepts. Can we imagine a trial with no adverse events? Get ready, smaller, shorter, faster, more granular and more predictable results. Five years from now we will look back at this moment. It's time to move on but I in no way expect all WW regulatory bodies to evolve the same processes. It is all about a collaborative learning process from here on out.