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Re: rkrw post# 15757

Wednesday, 01/11/2012 9:12:41 AM

Wednesday, January 11, 2012 9:12:41 AM

Post# of 80490
Upcoming Milestones (per post 15757)

-Finalization and communication of front-line design for Phase III CML trial with ponatinib (1Q12)

-Complete enrollment of Phase Ib/IIa trial of AP-26113 (1H12)

-Update on preliminary results from PACE Trial (1H12)

-Filing of ponatinib for accelerated approval with FDA (Mid-2012)

-FDA ODAC hearing for the approval of ridaforolimus for the maintenance treatment of soft tissue sarcoma (1H12)

-Approval of ridaforolimus by the FDA (PDUFA: June 5, 2012)

-Approval of ridaforolimus by the EMEA (2H12)

-FDA acceptance of ponatinib application for Accelerated Approval (3Q12)

-FDA Approval and launch of ponatinib for patients with positive-T315I mutational status or whose disease have failed other approved TKIs (1Q13)

-Initiation of registration-directed trial with AP-26113 (2013)

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