just wanted to raise another quick issue, does anyone have any further discussion
regarding other events? We focused on cardiovascular to a large extent, anybody have
any questions for the Sponsor or the FDA regarding other safety signals besides
versus placebo and for all control groups. The point estimate is to the left of unity; the
confidence intervals go past unity. Our interpretation of these data would be that we have
not seen evidence for cardiovascular harm, for other members of the class, for where
there are published data I just want to mention that the Vildagliptin data were also
recently made available, and I think they were presented at the EASD in 2008, thank you.
Question, if everyone agrees. We will be using the new electronic voting system for this
meeting. Each voting member has three voting buttons on your microphone, yes, no and
abstain. Once we begin the vote, please press the button that corresponds to your vote.
You will have approximately 20 seconds to vote. After everyone has completed their
vote, the vote will be locked in, the vote will then be displayed on the screen, I will read
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DR. BURMAN: Thank you. Dr. Savage, any further follow-up? Then I
censored, I guess I was wrong. I would just like to call your attention to - so this is
from a manuscript that was published just recently by Merck. The slide summarizes the
cardiac disorder SAEs, Ischemia Related AEs, Ischemia Related SAEs and fatal Ischemia
related outcomes. The Sponsor interpreted these data as not showing a signal; that was
their assessment. If I could show slide 3-88, these are data for Vildagliptin, Vildagliptin
is not approved in the United States. It is approved in Europe.
DR. BURMAN: No. All right. Then let’s move on to the Voting
This slide represents odds ratios for Cardiovascular SAEs for Vildagliptin