I will answer this under my private account as it more opinion than offical.
The current ethics application is around 10x more complex than the other two trials. The major factors are: 1) as far as the regulators are concerned RC220 is a “first in human” drug - for the ethics application all the history of bisantrene in patients might as well not exist; 2) we are effectively running two trials at once - an oncology trial and a cardiology trial. 3) we are running a combination trial in Phase 1 which is rarely done.
Despite all this complexity the team at Race have done an amazing job and have accomplished everything asked of them on time and to the required high standard.
General Comments / Chat, page-11743
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