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doingmybest

01/05/17 12:42 PM

#106 RE: DewDiligence #105

DD, valid point and agreed. But, why do you think they would accept the NDA after multiple meetings, and, on a priority review basis? And, keep in mind the other qualification points such as the central lab testing of the D-dimer, and, the overall population p value. Yes, the .054 was for the primary cohort, but, the central lab test data will be served up as supporting data. Lastly, this study was massive. Expecting two of these studies would use up excessive resources of time and money, and, I do not think two studies was the plan for the competitors who tried and failed to succeed in this space prior, rivaroxaban and apixaban.