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[Penny Roger$]

Wed. 5/25 - AFFY - NDA Submission in 2Qtr
Monday, May 09, 2011 1:19 AM



When: Wednesday May 25, 2011 10:00 AM - 2:00 PM
Event Description:

PALO ALTO, Calif. & OSAKA, Japan--(BUSINESS WIRE)-- Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE, 4502), announced on November 29, 2010 that following pre-New Drug Application (NDA) discussions with the U.S. Food and Drug Administration (FDA), the companies will move forward with their regulatory strategy for the investigational drug, peginesatide, for the treatment of anemia in chronic renal failure (CRF) patients on dialysis in the United States.
The company plans to pursue approval of peginesatide for the treatment of anemia in CRF patients on dialysis and the company believes that data from completed trials are sufficient for review of NDA for this indication.
The company has confirmed a Q2 2011 Timeline for NDA Submission.


SOURCE:
Affymax and Takeda Confirm U.S. Registration Strategyhttp://www.profeticconsult.com/apps/calendar/showEvent?calID=3533835&eventID=108858461