DR. KONSTAM: Infections?
DR. WOLF: Infections, yes.
DR. BURMAN: Good. Thank you all. Any final questions before lunch
going to be including assessments of serious infections to look for any complications that
might be related to the potential immune effect, which we have not seen in our clinical
development program to date. Of course, our randomized trial experience, including our
large randomized trial that provided an additional opportunity to look for that sort of an
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wonder if the Sponsor could comment anymore about it, where you are on this in
terms of assuming approval. What post marketing recommendations, follow ups,
screening are you going to propose?
Thank you all for the discussion. Does the FDA have any comments or
DR. WOLF: As part of our pharmacoepidemiologic program, we are
Well, we will break now for lunch until one o'clock. We will reconvene in
DR. KONSTAM: You will specifically be looking for that perceptively in
whatever large randomized trials you conduct going forward?
DR. WOLF: Yes. I mean, we will continue to monitor the lymphocyte
effect that we did see.