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today and one specific for Liraglutide for tomorrow. The Saxagliptin specific discussion

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point asks the committee to discuss whether the trial designs affect interpretation of

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cardiovascular results for the short-term period and for the combined short-term and

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long-term periods. For Liraglutide tomorrow, you will hear subgroup analyses

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comparing cardiovascular safety with Liraglutide to placebo and to active comparator.

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Of note, the primary comparison of interest for FDA is cardiovascular safety of

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Liraglutide compared to total comparator, and the guidance doesn’t talk about applying

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these criteria of 1.3 or 1.8 to subgroup analyses.

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improving the endpoints and analyses that we may apply to phase 3 programs that either

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were completed or near completion when the cardiovascular guidance was issued. We

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would also like the committee to discuss the adequacy of the statistical methods for

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measuring sensitivity of the results to analytical method.

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following question, which is identical for Saxagliptin and Liraglutide and it reads as

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follows. Based on the preceding discussion, has the applicant provided evidence of

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cardiovascular safety to conclude that Saxagliptin (today)/Liraglutide (tomorrow) rules

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out unacceptable excess cardiovascular risk relative to comparators, including evidence

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We would like to hear from the committee if there are suggestions for

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There are two other discussion points; one specific to Saxagliptin for

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Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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differences noted by type of comparator and the role that these separate types of

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comparatives could play in the evaluation of cardiovascular risk for future diabetes drug

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applications.

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Nonetheless, we would like the committee to discuss the relevance of the

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After those discussions we are going to ask the committee to vote on the

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