Good question. My assumption is the complete P2b/3 trial is scheduled to last 48 weeks per patient. By some criteria, not yet known, each patient then seamlessly transition into the P3 stage somewhere along the 48 weeks.
Interesting what others more familiar with trials will say.
Brich, Don't know how they will handle the Aussie arm of the trial but, we may see a "seamless" US trial arm. Take a look at this streamlined approach to approval of Keytruda in lung cancer. Think we will be seeing this "real time" approval method for NDA's in CNS diseases also.