T-38, once again thx for your insights here. IMO, you are correct to bring up how the SAUSAGE gets made, it is critical that we have both political connections and the technical/clinical wisdom of the new protocol language on our team.
I have also considered the possibility that understanding CNS Homeostasis will allow FDA&AVXL to start to work to peel the onion of medical mysteries that have destroyed so many lives. As they do(IMO) and as learning happens a new dynamic will be added to the trials process. Hopefully Dr. Woodcock and crew will be out in front b/c this next few years are going to be explosive for the FDA.