Hi MID, in one of my earliest posts in this bulletin board, which was likely disappeared, I said much the same thing about ethics. The Germans particularly are very anxious to maintain their medical ethics after the Nazi era. I delved into similar points you’ve made.
I too have always believed that the disadvantage for placebo was patently obvious, however, for other reasons, endpoints, pseudoprogression, etc., despite the obviousness, the trial needed to run still to be able to meet requirements for actual and ultimate approval. So while it was obvious, they simply had not enrolled enough patients or seen enough to be sure and the endpoint needed to change and they needed a substitute placebo. Otherwise, there would be too many off-putting objections, despite what was otherwise obvious and an approval would then require additional and really unnecessary trials to meet requirements ultimately. And, as I have said before, the regulators could not unblind the company, or their chance to change endpoints to survival would also be problematic. So they were not told why. But we know it was not caused by safety concerns and there are ultimately many fewer (disproportionately so) placebo patients.
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