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about this vote, having voted yes on the prior question, but the issue is a “Yes” or “No”

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vote doesn’t admit to a lot of grey area. There are grey areas when we consider these

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things and so, I voted no on this question because I think that we are clearly - we had

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some ongoing concerns, but I want to credit the Sponsor for having said that they are

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interested and indicate that they are going farther with additional studies and that this is

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in the works and they will do a good job on that, I am sure. So, and that was why I voted

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no.

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Unfortunately these studies were completed before the issue was raised and I just feel

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that the database available is inadequate to really address the cardiovascular safety issue.

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I think that data per se has very nice glucose lowering data, so I don’t have any concerns

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about using it for glucose lowering, but I would like to know the long-term safety, and as

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has been specified from the cardiovascular point of view, it really needs to be ascertained

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in people at the highest risk, which probably includes more than seven to ten years of

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known diabetes.

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been mentioned by people. I would like to just say a couple of things. It seems to me

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that the preliminary studies that are done on a drug prior to this type of thing clearly

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should include more data around the high-risk cardiovascular patients in the future. It

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DR. SAVAGE: I voted no. I think several of the reasons have already

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think, desire and happiness, that I think this is going to be, should be approved for and be

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available for patients and this as well as new therapies need to be made available in this

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area. Clearly, I think all of us believe that a new trial and a large high risk randomized

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trial needs to be done and otherwise, that’s it.

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DR. TEERLINK: I voted no as well, but I do want to share everybody’s, I

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DR. KILLION: I voted no, and is a conflicted or felt a little schizophrenic

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