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QUESTION AND ANSWER

DR. FESTING: What is the implication of a case in which genetic markers showed that both the Japanese rats and the US study rats were, in fact, genetically different?

DR. DE GEORGE: The implied result is basically the same as the current situation, which is that the study must be repeated. According to that 2-year assay, the doses were not selected properly for that group of animals, which means that we did not learn about the carcinogenic potential of the drug. If the rodent to human dose margin had been huge or the dose had been close to the appropriate dose, we probably would have been able to accept those data. However, in this case, the doses were clearly too divergent. The result is $1 million wasted and 2 years lost, the latter of which is probably more important.



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