Cortinaboy did you listen to the teleconferance? There was a question that asked what was the process if things in the committee meet didn't go to plan. The answer was (as happened in the EU) that they could go for a smaller market ie only for sufferers over 18 for example. Maybe it could be resticted to responders only? This could occur in between committee meeting and FDA decision.
expect another failure, page-3
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