certainly have time for discussion. I would want to - we’ll move on to the questions in
just a second. We have one further followup, Dr. Savage; you had a question that you
wanted to ask that was of relevance.
reemphasize the need for sub-group analysis. My only concern is the implication that it
has cardiovascular safety for all people with diabetes. For example, if you’ve got
grandpa and grandma over 65 years old, they are 10 years out from diagnosis of diabetes,
they’ve been on Insulin, there is no data for that group of people, and like we said in our
previous meeting, an absence of data does not mean safe. So, I would support earlier
statements that the label includes insufficient safety data for these certain groups.
DR. PARKS: We would be in agreement with you on that.
DR. BURMAN: Thank you. Sponsors.
DR. WOLF: So, I feel a little uncomfortable talking about another
DR. BURMAN: Thank you. If there are no further comments, we
relaxing the percentage, instead of 95% confident, settle for 80% or something lower
than 95, that way you can say, okay, we ruled out a harm of 1.3 or something rather than
ruling out a harm of 1.8.
drugs is complex in its own right, but I wondered if there is any evidence that anyone
knows of that the one drug in this class that has been approved and is out on the market is
associated in anyway with any increase in cardiovascular risk, I don’t know of it.
Sponsor’s drug. Merck has published data on the cardiovascular safety experience for
Januvia, if I could please project slide 3-86. That’s fair enough. I thought I was being
DR. SAVAGE: Okay. I realize that dealing with issues of class effects of
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DR. BURMAN: Thank you.
DR. HENDERSON: As the consumer representative, I want to