Anavex Life Sciences Corp (AVXL)

[Ortiz]

“Labeling is also a hurdle in the approval process. Anavex will have a lot of work to do to get the labeling approved for each indication that AVXL 2-73 may treat in patients that vary in age, size, condition, genetic make up, etc.”

Thanks for bringing labeling to the conversation as labeling, or the package insert (PI), is not as easy as many would think. The material presented to the FDA must be detailed and consistent with the trials results, otherwise Anavex will be required to make corrections, which contributes to delays.

Hopefully Anavex is using its time wisely to hammer out the PK/PD of 2-73 section and create a general template where pertinent information would be inserted once the data is analyzed.

IMO

IMO