Anavex Life Sciences Corp (AVXL)

[sokol]

Investor:

I agree. With or without analyst grilling, Missling needs to explain all of this. It would be best if Missling clarified everything before questions by analyst, but you can bet that analyst will grill him if he does not do so.

I am confused though about the dates that Anavex may have been involved in discussions about the endpoints and any changes to endpoints. As I remember, wasn’t there some sort of contact with the FDA in September of last year? What happened in September versus what happened in December?

I think, however, that the RSBQ AU may be a better endpoint than RSBQ alone, which has been criticized by experts. See https://www.clinicaltrialsarena.com/analysis/rett-syndrome-endpoints/. In pharmacology, the dose response curve shows the relationship between the amount of a drug taken and its effects on the patient. The area under the plasma drug concentration-time curve (AUC) reflects the actual body exposure to drug after administration of a dose of the drug. The Clinical Global Impression – Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Isn't it best that the clinician assess whether the Rett patient's condition has improved or worsened at points in time in conjunction with the patient's concentration of the drug (AVXL 2-73)? Is this method better than RSBQ alone, which has be criticized by experts as I mention above?

According to some experts, RSBQ on its own may not be reliable; however, I think that it would be best that Anavex “comes clean” and acknowledges what happened, and demonstrates/explains what the original primary endpoints show and how that compares with the primary endpoints as changed. What happened? Who caused it to happen? When did it happen? Why did it happen? Do the changes matter? If so, how? Etc., etc.

I have been thinking that nothing nefarious has taken place and that Missling and Anavex quite simply may not be that adept in making presentations that are clear and understandable. February 9th presents an important opportunity for Anavex to rise to the occasion and right the ship.