Replies to post #297189 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

There will be no need for another Phase 3 trial for ANAVEX2-73 for Treatment of Early Alzheimer's Disease the current Phase 2/3 trial is and will be sufficient for regulatory approval. All we need is very good p values when comparing the active drug cohorts (Anavex 2-73) with the placebo cohort. The trial size is already part of the p value and power calculation.





https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167374/

There will be no need for another Phase 3 trial for ANAVEX2-73 for Treatment of Early Alzheimer's Disease the current Phase 2/3 trial is and will be sufficient for regulatory approval.

Good luck and GOD bless

[powerwalker]

Phil, I'm thinking, pre-AD, that the evidence of 2-73's benefits is going to be convincing for the authorities with efficacy in AD, Rett and PDD, but possibly not in the individual numbers for each disease that Anavex and the FDA-types arrive at an agreement that allows for the commercialization of 2-73, but with a P-4 to provide the long-term support for those decisions.

With the various analyses being done via PM/AI in three different diseases, approval in Australia, Europe and/or USA might not be as far off as some project. At least, that is my prayer for me and all those who are slipping into the AD hole as well as those already in the hole.


ANAVEX NOW ... RIGHT NOW ... MONO-STYLE ... for LIFE ... and for ALL AGES!!!