Replies to post #188091 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Kevli33

It seems a lot of the focus has turned away from the FDA (U.S.) as they have been behind and not
leading as you state. What are your feelings on someone on the Anavex management team (Dr. Fadiran)
having such extensive inner workings of the FDA? Do you think he has helped "steer" TGD away from
the old thinking of the FDA...or perhaps he has helped guide him in the new 21st century way (precision
medicine etc..)?

Kevli33, thx for your generous comment.
The FDA do a great job at some things(guidelines, rules for compliance..)I do think they have too big a scope, but that is another conversation.

I bet you are right and that Dr.M. has got guidance and support on how to go about getting all this work done w/small SAB staff. Who knows just how much influence is needed. The FDA is clearly broken on CNS disease trials. My guess is Dr.G. bailed b/c he could not get the FDA structure to move fast enough. Dr.M, Dr.G. and likely Dr.F. could see the path and progress being made by AVXL. While the FDA was still trying to figure out what to do about the AMYLOID thesis and how to explain an embarrassing complete failure then something happened to make Dr.M. pull away from CNS trials in the U.S.. You might have nailed it with the Dr.F. influence card. I do not have a better explanation for what was obviously a brilliant (company saving) decision process to go out side the US to get trials done.

My guess/hope is that AVXL will only run AD trials of any size in the U.S. after they have nailed down a few wins and a certain pass/fail set up. He will not run AD trials here until the Biomarker pieces are solid (including GUT BIOM). A senior staffer like Dr.F. would also be valuable as a knowledge source for WW trial selection. We do not want to burn time and money in a system that is not credible outside the U.S.. Somehow they chose Spain (who knew how good a choice that was?) probably Dr.F. drove that also.

Even though this is taking a lot longer than I thought it would my sense is we are on the right path. Take care and, "Keep Em Flying".