A.P. Pharma Puts Off APF530 Launch To 2014 After Another FDA Rejection
This article was originally published in The Pink Sheet Daily
A.P. Pharma faces a second commercial setback as FDA issues another “complete response” letter for its long-acting granisetron in chemotherapy-induced nausea and vomiting.
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Patients with the most severe type of disease were all randomized to treatment with the study drug, which may have had a negative impact on outcome, the Israeli company suggested.