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certainly have time for discussion. I would want to - we’ll move on to the questions in

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just a second. We have one further followup, Dr. Savage; you had a question that you

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wanted to ask that was of relevance.

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reemphasize the need for sub-group analysis. My only concern is the implication that it

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has cardiovascular safety for all people with diabetes. For example, if you’ve got

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grandpa and grandma over 65 years old, they are 10 years out from diagnosis of diabetes,

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they’ve been on Insulin, there is no data for that group of people, and like we said in our

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previous meeting, an absence of data does not mean safe. So, I would support earlier

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statements that the label includes insufficient safety data for these certain groups.

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DR. PARKS: We would be in agreement with you on that.

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DR. BURMAN: Thank you. Sponsors.

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DR. WOLF: So, I feel a little uncomfortable talking about another

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DR. BURMAN: Thank you. If there are no further comments, we

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relaxing the percentage, instead of 95% confident, settle for 80% or something lower

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than 95, that way you can say, okay, we ruled out a harm of 1.3 or something rather than

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ruling out a harm of 1.8.

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drugs is complex in its own right, but I wondered if there is any evidence that anyone

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knows of that the one drug in this class that has been approved and is out on the market is

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associated in anyway with any increase in cardiovascular risk, I don’t know of it.

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Sponsor’s drug. Merck has published data on the cardiovascular safety experience for

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Januvia, if I could please project slide 3-86. That’s fair enough. I thought I was being

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DR. SAVAGE: Okay. I realize that dealing with issues of class effects of

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DR. BURMAN: Thank you.

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DR. HENDERSON: As the consumer representative, I want to

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