Some items of concern for me as they relate to the actual long term prospects of A2-73 actually being an effective drug based on anecdotal evidence from this safety/ dose optimization open trial. (Not to be confused with the anecdotal results near term effects on share price)
"Practice effects in AD have not been discussed often. Perhaps, this is the result of an expectation that many patients are substantially amnestic and unable to learn and consolidate item-level information over repeated testing. However, memory impairments are dependent on individual differences in premorbid ability and disease stage, thus creating some variability in training. Furthermore, impairments in other domains may not be as severe as those in neural systems associated with the primary amnestic symptoms (hippocampal and medial temporal lobe pathology) and so may also increase the likelihood of practice effects (e.g., some learning may engage striatal procedural learning systems that may be relatively intact in AD). However, we acknowledge that practice effects in AD and MCI are smaller than those in healthier populations, and their significance perhaps arguable. At the same time, it should at least be considered that practice effects could serve to obscure ongoing cognitive deficits in progressive degenerative dementia.
Even with these caveats, practice effects were observed and commented on in early clinical trials of tacrine in AD [14]. Practice effects on the Mini-Mental State Examination were discernible using repeated-measures statistical techniques in AD [15]. Indirect evidence for practice effects in AD patients comes from the large number of cholinesterase inhibitor clinical trials in which both the drug and placebo groups demonstrated improvements in performance-based outcomes measures early in the trial (in the 3- to 6-month period) [16], [17], [18] with maximum effect sizes (ESs) in the 0.10 to 0.15 range. In contrast, practice effects in Alzheimer's Disease Neuroimaging Initiative's (ADNI) AD subjects, tested at 6 monthly intervals over the first 2 years, were negligible".
Just like many things in life the more often an exercise is "practiced" and the closer those practices are concentrated together the more likely a "practice effect" is realized. "Tested at 6 monthly intervals" is a confusing phrase, I believe it means once every 6 months rather than 6 times a month if so Anavex doing the test at close intervals may be confounding the results especially since the trial lacks a placebo.
"Consider the following thought experiment. An outcome of a prevention trial in preclinical AD suggests that a neurodegenerative cascade has been arrested. This effective disease-modifying treatment would result in stability in cognitive function or small improvements, insofar as the neurodegenerative effects are reversed. The untreated group would decline, albeit subtly. A sensitive set of tests assaying important cognitive domains and resistant to practice effects would accurately monitor this scenario. In contrast, using tests subject to practice effects, both groups would improve, inaccurately representing the drug's efficacy, resulting in the strong possibility that differential effects would be masked as the within-group change would be much greater than the between-group change, and resulting in a serious type 2 error. In other words, the cognitive signal would have been misaligned with underlying neurobiological changes associated with neurodegeneration (neural system compromises) and rectifications thereof. We think that interpretation would be parsimonious and accurate if a treatment-related signal could be identified in a group that would otherwise demonstrate measurable subtle decline across time points."
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