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Biotech / Medical : Welcome to the POTP board, the DPP-IV company
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To: pgo-neil who wrote (78)5/15/2007 11:16:01 AM
From: former_pgs   of 90
 
>I would think this unscheduled peek would have to be coordinated and approved by the FDA [the stat analysis as a minimum]. But I don't find any reference to that sort of coordination in the PR. How standard is this approach [with or without FDA approval]? <

Strictly speaking, it only needs to be coordinated if they have an SPA and they want to maintain the integrity of the SPA. If not, they're free to take as many peeks as they wish; the obvious downside is that the more they do it in an unscheduled and undisciplined manner, the more chance they'll have to compromise the trial in the FDA's eyes.
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