The original trial protocol had readout at 31 weeks, I believe. So one could argue that the per protocol data has been released. It is also based upon this data that Anavex claims the FDA has been providing guidance for the long awaited P2/3 trial. In other words as far as we can tell, the FDA has not required further data in order to potentially agree to a P2/3 trial.
In this context we are not owed further data, except for the fact that Missling has promised extension study data as it becomes available...
We then speculate that ever since the extension study has continued to provide data that can further inform the definition of the P2/3 trial design and according to Missling minimise the risk of failure.
It seems then our best hope is that the wait is all for good reasons soon to be revealed...