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noretreat

02/10/15 2:18 PM

#91095 RE: Jhawker #91094

I think Leo said 1300 or 1400. IMO, if they use a new comparator instead of D, and stick with just one B arm they could get by with as few as 1000. 500/arm produces pretty strong statistics. But the FDA may want larger samples. The study will likely be 2 phase 3's running concurrently with interim efficacy results overall and then results for some key sub-groups.