Anavex Life Sciences Corp (AVXL)

[sokol]

Anavex trials for dummies (like me): The purposes of the AVXL current clinical trials does not include proving efficacy although the current trials indicate efficacy. The primary purpose of the study is to study safety and dose tolerance in the subjects; however, as secondary endpoints, the study has measured a battery of cognitive function metrics such as MMSE, ADCS-ADL, and EEG/ERP for exploratory purposes; and bioavailability of the oral capsule formulation.

These positive benefits have been demonstrated so far:

1. Safety is shown.
2. EEG/ERP (P300) signal improved. The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making. P300 may be recorded by electroencephalography (EEG) -- measured by electrodes. It is an objective measure of brain waves. (With a great deal of escort Scott in Post# 32247 has concluded it appears November results show, on average, all 36 patients were closer to the healthy control than the 12 patients were in July.)
3. Cognate (underlying skills) test improved across the test batteries.
4. MMSE -- Mini Mental State Examination -- scores improved.
5. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), although maybe not great, did show overall improvement.
4. PK (pharmacokinetic) and receptor pharmacology profile...are not issues despite what Martin Shkreli, a short, has tweeted.

People attending the November 7, 2015 Alzheimer's conference Barcelona believe the trials show promise and will continue to the next phase or phases. A number of scientific articles support the Anavex theory that the receptors target by Anavex therapy are key to treating AD and other CNS diseases. Besides the ongoing human clinical trial by Anavex, animal studies show promising support.

The bottom line is that efficacy is yet to be proven by further phases of this clinical study, but results so far are very encouraging. The FDA and experts in the field admit that the drugs approved to treat AD are not working except possibly Donepezil (Aricept) that alone has some limited benefit and possibly when combined with Anavex 2-73 may have much more significant benefit.

Efficacy is yet to be clinically proven. On the other hand, no person can say with any credibility (any credible scientific evidence) that Anavex and its therapy will fail.

We will know by tomorrow morning, November 9, 2015, when Anavex posts late breaking news about the clinical trials. The latter was the subject discussed at the Barcelona conference yesterday. Some slides tweeted from that conference are interesting. One is entitled: "Anavex 2-73 Reverses Cognitive Deficits Measured by Standard ERP Methods at week 5" . You may find this slide here: https://pbs.twimg.com/media/CTMsjZYWcAAZ6J5.jpg:large