As I posted last month (#499642). No major change in SP expected with this type of PR
So as long as there is no major safety issue that derails the program (for non-immunology drugs usually liver, cardiac) the study can be claimed to be a success. Success in the primary (safety) outcomes is mostly baked into the SP so is not a big deal by itself.
So one prophecy fulfilled. Will another one also come true? A couple weeks earlier I had posted (# 498540)
I expect Schizo readout before the MAA is withdrawn or denied.
Therefore by the end of October, after the coffers are refilled, we should be seeing a PR announcing the withdrawal and a plan to initiate a P3 'soon'.
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