Published in Health Insurance Law Weekly, August 22nd, 2004
Alexion reported on June 14 that they, together with P&GP, had reached agreement with the U.S. Food & Drug Administration (FDA) on the design for the PRIMO-CABG-2 study under the Special Protocol Assessment (SPA) process. It is expected that, if successful, this trial will complete the filing package that will serve as the primary basis of review for the approval of a Biologics...
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