I think there are many different interpretations one could infer from this announcement. I think it is the duty of management to further clarify which interpretations are correct. The trial has the ability to stop for futility, which it hasn't done. The trial can also advance to stage 2 if there is already a clear benefit, which it also hasn't done. My best guess is that even though it has now recruited 150 patients, the majority of patients naturally haven't been in the study long enough to say whether or not there is a statistically significant difference. However, that is to be expected at this stage given the data we know from our phase 2 trial. Statistical significance would likely not start to emerge in overall survival until around the 2.5 year mark for the study. GBM Agile itself does not determine FDA approval; they can only provide data. Certainly, if it looks hopeless, they will stop for futility. However, they are continuing the trial, so the data is just not mature enough yet to say either way. I don't think there is any new info, good or bad, in that regard. Management should clarify and confirm/refute any claims to the contrary.
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