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Re: microcapfun post# 111487

Sunday, 12/26/2010 3:13:19 PM

Sunday, December 26, 2010 3:13:19 PM

Post# of 257285

I'm just saying it doesn't look likely - at least if the SPA primary endpoint involves ACR20.

I respectfully disagree. In some cases, the FDA has allowed a drug with only half the clinical benefit of the comparator to be deemed non-inferior. With a generous non-inferiority margin set forth in an SPA, based on the data to date I would say that a finding of non-inferiority is reasonably likely in this instance.

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