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Following its review and analysis of the complete response letter received from the FDA on April 30, 2009, Northfield determined that further clinical development of a reformulated version of its PolyHeme human red cell substitute product, including additional clinical trials, would likely be required before it could again seek to obtain FDA approval.
Northfield concluded that the time and substantial expense required to complete this additional clinical development, together with significant uncertainty that FDA approval would ultimately be obtained, made it unlikely that sufficient additional capital could be raised to support such further product development.
On May 8, 2009, Northfield announced that it had terminated substantially all operational and staff employees at its manufacturing facility and headquarters.
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