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genisi

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genisi

Re: DewDiligence post# 93404

Wednesday, 03/31/2010 12:33:23 PM

Wednesday, March 31, 2010 12:33:23 PM

Post# of 252331

The FDA is questioning CEPH’s data on the co-primary endpoint called Patient Global Impression of Severity, which is subjective. This would seem to be a case where an SPA would have been helpful.

I don't understand what do you mean, the phase III trial for Nuvigil in jet-lag was conducted under an SPA.
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