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who wrote (
10/22/2010 11:19:27 AM
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It is not a P3 as it is not a randomized trial. It is a large P2 with about 125 pts or so in relapsed pediatric ALL. This is a tiny market, only a few hundred pts per year (fortunately), and there are many clinical trials, which made enrollment of this study very slow, it has been ongoing for 3 years I believe. The company intends to file with the FDA based on the current study, there is no realistic way to do a large P3 in this patient population, nor would it be ethical to deprive children of a drug that was felt most likely to work based on P2 data as compared with historical control.
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