Anavex Life Sciences Corp (AVXL)

[nidan7500]

tradeherpete

How long should it take for Dr. Missling to communicate to the FDA on the next steps to be taken?

And how long does the FDA have to respond?

IMO, a great deal of thought and planning must be applied to just what will AVXL ask the FDA to do? Is it a direct assessment of a specific trial/ indication data (summary of all relevant information) for one or multiple indications (AD/PDD/RSD...)? Looking for go/no go? Are we looking for MOA validation/verification?

Will the FDA need to analyze new devices/technology applications used during PDD trials? eg (actigraphy) ?

Keeping things focused w/a risk averse regulatory body is not easy. We will be required to present strong data from systems which have all been through and accepted BY FDA V&V processes. If not they could go on for many months just agreeing on how the trials and systems used were controlled and validated. Long story which takes time to get prepared for.

The decisions made will be carefully picked at by BP and others.

FDA are risk averse. Do your homework and understand exactly what your question is. Just exactly what are we asking for? Approval of a specific trial data via Old school, or basket Validation of MOA, or some combination new trial process results assessment-acceptance.

It would be great if the FDA were an open and supportive regulatory body who are easy to do business with and are able to walk and chew gum. These are the same people who have managed a regulatory process for which symptoms have been treated as final solutions. A Regulatory body who has recently stated they were "really not sure when AD starts", after decades of chasing a/the wrong solution.

In summary: Dr.M. must be very direct with exactly what he is asking for from the FDA. What do we want them to agree to? I have no information on how long FDA will require to respond.