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Even the review paper summarizing this study noted the results are not overly informative and reliable due to the lack of objective measures

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While voting yes, Christopher Lieu, committee chairperson and director of the Gastrointestinal Medical Oncology Program at the University of Colorado, acknowledged that a positive decision could lead to a slippery slope in terms of the degree of clinical evidence that will be required of future drug applications in similar rare and difficult-to-study indications