By the time the trial was halted it was clear that OS would be the primary goal, they knew about pseudoprogression back then.  I believe that all the regulators were in agreement back then, but creating a SAP in which all four regulators agree to precisely the same language probably took much longer than anyone thought it would.

 

I cannot say that the company went to work on it immediately after the halt was lifted, they didn't have to, they had the agreement of the regulators by the time the halt was lifted.  Unfortunately, it's one thing to get oral agreement, it's another to get all to agree to precisely the same language.  When the U.K. and European authorities changed their version of Clinical Trials you know it was done, but for unknown reasons the U.S. version, which the company controls, wasn't changed.  L.P. clearly plays her hand close to the vest, but she knows she has a winning hand.

 

Gary