FDA Places PharmAthene's (PIP) SparVax rPA Program on Clinical Hold
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PharmAthene, Inc. (AMEX: PIP), has received notification from the U.S. Food and Drug Administration (FDA) that its SparVax rPA anthrax vaccine program has been placed on clinical hold. The Agency indicated that the Company will receive a letter providing details of the basis for the clinical hold within 30 days. During this period, PharmAthene will continue to provide the agency with analytical data from its recently produced GMP lot of material. The clinical study, which was expected to begin by the end of this year, has not enrolled any subjects to date and accordingly, there have been no adverse events reported.
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