Anavex Life Sciences Corp (AVXL)

[12x]

Doc, page 1 of the new FDA guideline does seem to cover Stages 1 through 3 (see below). But do we know how to map 5 levels of CDR scores (0,0.5,1,2,3) to the 6 stages in FDA guidelines?

Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry

I. INTRODUCTION

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the onset of overt dementia (i.e., Stages 1 through 3; discussed in section III). These stages are collectively referred to as “early AD” in this guidance; however, it is recognized that AD occurs on a continuum and patients in the last stage of early AD (i.e., late Stage 3) and patients with AD in the earliest stages of overt dementia (i.e., early Stage 4) may not differ significantly in clinical presentation.