Mark Goodman UBS (Mylan CC)
....you {MYL CEO} have talked about Copaxone. I just want to make sure I understand. You said you got feedback from the FDA and in those comments there were not any concerns around the sameness of your products. So there obviously were some other issues. Can you tell us what they were? Were they just minor procedural things that you quickly gave responses to and you feel really comfortable that the FDA has now gotten everything that they need? Were the things they asked, were they surprising? I'm just trying to understand. I think we can understand why you would take it out of this year's numbers to be conservative, but it doesn't seem to make sense that you would be taking it out completely given the commentary there."...
Mylan’s president -
"On Copaxone, let me -- Copaxone has -- we all knew it's a complex product and everything is not black and white and there's a little bit of gray. The [citizens] petition response and Momenta's approval gave us a lot of confidence that fundamentally, we are on the same page. The last bit of questions, the clarifying questions are around fine tuning -- I will not call exactly the fine tuning but there are some different methodologies which we have used and we're trying to give them more information about some of the aspects to see more clarity. We just received questions. We're in the process of turning it around in the next couple of days and then we'll be working very closely with the FDA to take it to the next logical stage.” (Thomson Reuters)
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