my understanding was that the ema asked for additional trial...

my understanding was that the ema asked for additional trial data to support the inclusion of the growth factor. data the original management would have had if they hadn't rested on their laurels for years and years. The current trial was designed to fulfil the dual requirements of a fda phase 2 as well as to provide the additional patient data for the ema.

that has been the plan from the start of the restructure.