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genisi

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genisi

Re: DewDiligence post# 144017

Tuesday, 06/19/2012 5:00:42 AM

Tuesday, June 19, 2012 5:00:42 AM

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ORR in ITT population is 22.9% in the FDA analysis, and in the 'truly' unmet need (patients unresponsive or intolerant to approved agents) is above 20% in all subgroups, so I think the efficacy demand is met but seems it may not justify the risk for cardiotox in the FDA's view and chances are quite high they will want more data.
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