Anonymous
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Anonymous
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will be re-posted after FDA advisory review meeting in August. Can you say Mulligan??
"Concerning tofacitinib as you know the FDA advisory committee recommended approval on May 9. Subsequent to that meeting, the FDA requested additional analysis of the existing data in our NDA. We are planning on providing them that information in early August.
Given the timing of the additional analysis requested, we anticipate that the FDA may require additional time beyond the August 23 PDUFA date to review this information." - Ian Read
"Concerning tofacitinib as you know the FDA advisory committee recommended approval on May 9. Subsequent to that meeting, the FDA requested additional analysis of the existing data in our NDA. We are planning on providing them that information in early August.
Given the timing of the additional analysis requested, we anticipate that the FDA may require additional time beyond the August 23 PDUFA date to review this information." - Ian Read