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DR. KONSTAM: Infections?

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DR. WOLF: Infections, yes.

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DR. BURMAN: Good. Thank you all. Any final questions before lunch

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going to be including assessments of serious infections to look for any complications that

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might be related to the potential immune effect, which we have not seen in our clinical

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development program to date. Of course, our randomized trial experience, including our

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large randomized trial that provided an additional opportunity to look for that sort of an

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issue.

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approximately one hour. Please take any personal belongings with you. The ballroom

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will be secured.

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

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wonder if the Sponsor could comment anymore about it, where you are on this in

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terms of assuming approval. What post marketing recommendations, follow ups,

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screening are you going to propose?

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(No response.)

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Thank you all for the discussion. Does the FDA have any comments or

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DR. WOLF: As part of our pharmacoepidemiologic program, we are

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or comments?

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(No response.)

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Well, we will break now for lunch until one o'clock. We will reconvene in

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DR. KONSTAM: You will specifically be looking for that perceptively in

whatever large randomized trials you conduct going forward?

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DR. WOLF: Yes. I mean, we will continue to monitor the lymphocyte

effect that we did see.

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questions?

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