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Re: None

Friday, 06/15/2007 10:05:58 AM

Friday, June 15, 2007 10:05:58 AM

Post# of 12660
FDA Process Afficianados - Sam here
Fellow posters,
In another life I used to give Standardization & Evaluation (Stan Eval)flight checks to fighter pilots. The standard take was any check pilot worth his salt could fail anyone on any flight check - you just had that power.
Is the FDA licensing process subjective enough for a hostile FDA to fail us on the interim look, even if we pass statistically?
Could they cast enough doubt on the validity of DNDNs results that they could force approval to await Impact study completion?
TIA, sam

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