Anavex Life Sciences Corp (AVXL)

[nidan7500]

Talon, we might agree that the process for getting the new FDA trial guidelines written is going to take a while. As positive as the change looks to everyone I am wondering/concerned about the timing.

I do not want to see A2-73 hold up trials any longer than absolutely needed to get things rolling. Dr. M. has (IMO) cleverly planned start trials in other venues, which will help to keep some pressure on. It has been noted that other CNS trials have been started since October 2017 using old FDA rule sets. AVXL has chosen not to do that, for reasons we agree with.

Certainly the new 21stCCA methodology is not mature from the regulatory side so there will be delays as the government and pharmaceutical industry work through the process. But, in the future there will be fewer drug failures because of trial design and more success because of targeted disease subgroups/endpoints.

But, governments have ways of screwing things up if you are depending on them to get it right soon, never mind schedules and mission creep. So, what are chances of AVXL starting a hybrid CNS trials protocol? Part precision/part "we got this" thinking? I have zero faith in government/politicians and the whole established FDA crowd....BUT, I have total faith that they would all jump on a certain win if they saw one.

You seem to have keen insights into how the new ACTC crew will work(much more that I do), how flexible will they be to hybrid solutions while they strive for perfection? It is unclear to me at this point if M. will sit around and wait (hope not) or will he do a hybrid precision trial based on good science?