If stopping for futility, wouldn't you think they would have pushed for increased study size at the 45% readout, if it was heading that way? Adding an additional 15% you wouldn't think it would trigger it from 'steady as she goes' to 'bail'.
I think the timing is right for a DSMB readout. If it was a simple 'steady as she goes' at the 60% mark then I don't think we would go through this trading halt situation. If there was a recommendation to stop, I would have thought they would not publish/announce that until they spoke to FDA and NIH as it would compromise the trial if they chose not to listen to DSMB. Which leaves me an uneasy possibility of recommendation to increase study size which would involve NIH and FDA with a resolution process and announcement required.
Ann: Trading halt, page-142
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