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‘We believe the results of the PIX301 clinical trial ought to be analyzed with the correct threshold that is standard for trials of this type in which only one efficacy evaluation was conducted.’ FDA rules provide a formal dispute resolution process to obtain review of any FDA decision, including a decision not to approve an NDA, by increasing the matter with the supervisor of the FDA workplace that made the decision. The formal dispute resolution process exists to encourage open, prompt discussion of scientific disputes and procedural disputes that occur during the drug development, brand-new medication review, and post-marketing oversight processes of the FDA. Based on the guidance docs available from the FDA, CTI expects an FDA decision on the appeal in the first one fourth of 2011.