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DewDiligence

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Re: poorgradstudent post# 110039

Wednesday, 08/17/2011 1:12:19 PM

Wednesday, August 17, 2011 1:12:19 PM

Post# of 252545
EMA accepts PFE’s Crizotinib and Bosutinib for review:

http://finance.yahoo.com/news/Pfizer-Announces-European-bw-1561165753.html?x=0&.v=1

If there are no hitches, both drugs could be approved by the EMA during 2012; the exact timing is unclear insofar as EMA reviews are generally more iterative than FDA reviews.

In the US market, the Crizotinib NDA in ALK+ NSCLC is pending with a PDUFA date in Sep or Oct 2011 (#msg-63205025). PFE has not yet submitted the Bosutinib NDA for 1st- and 2nd/3rd-line CML, but has stated its intention to do so in 2011 (#msg-57387806).

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