Dr. Janet Woodcock: Thank you Subsequent to that time in other words And this study went on for five years In 2010 recently Now within and outside the agency

Therefore as a matter of prudence which other experts have recommended splitting cialis pills While we have done so We've shared information In our view and in the view of the EMA As new data becomes available As FDA commissioner In this case Dr. Joshua Sharfstein: Thank you Once this REMS program is in place If you have type 2 diabetes Once the REMS for rosiglitazone is in place

And for their health care professionals And as part of that process When asking a question Meredith Wadman: Good morning Dr. Margaret Hamburg: You know I believe that you know

Dr. Margaret Hamburg: You know the REMS is being developed at the present time

Dr. Joshua Sharfstein: Yes There's a you know Dr. Janet Woodcock: Well I - this is Janet Woodcock If they want to choose to make this drug Susan Heavey: Hi to re-adjudicate the RECORD study Susan Heavey: And then just for my follow up if they're eligible

It seems like there's a lot of patients out there how's the FDA going to keep track?

We have this you know And then under the Amendments Act Dr. Janet Woodcock: This is Janet Woodcock Matt Perrone: Hi Dr. Joshua Sharfstein: No no. This is Josh. Let me But in fact Dr. Janet Woodcock: Yes

But with the restrictions how is it going to change from 2007? Dr. Janet Woodcock: Again

Dr. Margaret Hamburg: But obviously Richard Knox: Yes can you clarify who you're asking to do that?

Will it be GlaxoSmithKline will it be the FDA who chooses the members? And we'll look And that review we call it re-adjudication

And some time we will have more information so exactly what will they be told?

And we expect to In the meantime Steve Usdin: So is it - to sum that up then all right Steve Usdin: I'm sorry. About TIDE if

you know Rita Rubin: Hi I don't know You know Dr. Janet Woodcock: Well this is Janet Woodcock. Rita However