This is true, but the bigger issue was PET scanning of patients looking for EMD who are responding well to conventional treatment. The doctors were reluctant to do this. We solved the problem by moving the PET scan to after enrollement in the treatment arm (RC110 works for patients without EMD too), but the trial was cancelled by the management at the time before this change came in action.
Tweaking early stage trials is very common (basically universal). You learn what works or doesn't work in practice and make changes to the protocol. Phase 1 and 2 trials are where you learn how to use your treatment best in patients, while Phase 3 is about proving your drug works or not.
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