Monday, October 16, 2017 10:17:29 AM
Ex, CVN was a safety concern, not a futility concern - not at all comparable. Furthermore, any futility recommendation at an IA is only for internal info and the co can decide on its own whether to continue or not. So far as I know, on a futility rec, there is no requirement for any consultation with the FDA on how to proceed nor is there any actual indication that any such meeting ever actually happened SFAIK. The trial simply proceeds as per the protocols. The meeting is mere speculation with no reason to have it. You know the saying "If you ask the answer will be NO!"
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