A.P. Pharma Inc. (APPA) announced that the U.S. Food and Drug Administration has accepted for review the New Drug Application or NDA for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting or CINV.
APF530 is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. Based on the Prescription Drug User Fee Act, the FDA has issued an action date of March 18, 2010.
In a separate press release, A.P. Pharma announced that, on July 17, it received notice from the Listing Qualifications Staff of The Nasdaq Stock Market indicating that it has not regained compliance with Nasdaq Marketplace Rule 5450(b)(1)(A), the minimum stockholders' equity requirement.
As a result, the Company's securities would be subject to delisting from The Nasdaq Stock Market, unless the Company requests a hearing before a Nasdaq Listing Qualifications Panel.
The company said that it plans to request a hearing before the Panel at which it will present its plan for regaining compliance with all applicable listing requirements.
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