Anavex Life Sciences Corp (AVXL)

[Doc328]

Ray is right.

Here's the data for the 2b/3
https://www.clinicaltrials.gov/ct2/show/NCT03790709

Official Title: A Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-week Safety and Efficacy Trial of ANAVEX2-73 for the Treatment of Early Alzheimer's Disease (AD)
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : June 30, 2022

This implies the last patient, last visit in May 2022 with last safety visit (for patients who chose not to roll over to OLE) in June 2022. 4 months is plenty of time for sites to answer all the queries/DCFs, scrub and impute data per the SAP, do the analysis and put together the report for the company. I definitely would not be shocked to see later in the year, given the track record, but my best guess estimate is October as phase 3 data is actually easier to analyze than phase 2

A 2b/3 study is a 2b study that has primary and secondary endpoints appropriate for a pivotal phase 3 trial (i.e. one that the FDA considers phase 3). The 2b/3 designation usually means there will be some adaptation after mid point (not necessarily 225 patients but some prespecified number in the SAP) analysis is used to determine if (1) the size of teh study needs to be enlarged and (2) if some groups should be dropped (i.e drop the 30 and keep the 50 and placebo to increase group n). Though an unpopular view, I believe there is a > 50% chance a second phase 3 will be needed for NDA submission even if data is good. And, if the data just misses (i.e. one or both coprimary endpoints have p=0.07), possibly 2 more.