As stated near the end of your post, 9 patients will be recruited in the first part of Stage 2 irrespective of efficacy.
All that can be concluded from Stage 2 at this stage is:
* the treatment has been safe
* not all 3 have responded. If all 3 had responded, the null hypothesis (that the treatment isn't effective) would have been rejected. That would have been announced, with the trial continuing until 9 were recruited.
General Comments / Chat, page-8084
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