SPPI - Spectrum Pharma rises 9% after FDA completes re-inspection of manufacturing facility for eflapegrastim drug

• Spectrum Pharma ( NASDAQ: SPPI ) is trading ~9% higher after the company said the U.S. Food and Drug Administration completes re-inspection of drug substance manufacturing facility for eflapegrastim to treat chemotherapy-induced neutropenia.
• "The completion of the FDA re-inspection of the drug substance facility for eflapegrastim is a critical step in the regulatory review process. With this hurdle behind us, we have turned our focus to our potential approval and commercialization," said Tom Riga, President and Chief Executive Officer of Spectrum Pharma.
• The company also said it anticipates an FDA decision by the PDUFA date, which is by September 9, and is actively preparing for the potential commercial launch.
• The company’s cash was approximately $68M.

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