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news.AP Pharma, a California-based specialty pharmaceutical company, has updated on its progress related to the APF530 complete response letter it has received in March 2010 from the US Food and Drug Administration (FDA).
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APF530 is indicated for the prevention of chemotherapy-induced nausea and vomiting.
AP Pharma is in the process of preparing a resubmission responsive to the deficiencies listed in the complete response letter.
Acting chief executive officer John Whelan said the company’s management team has focused its efforts on addressing the issues included in the APF530 complete response letter and arranged Type B meetings with the FDA for later this quarter.
The company is now actively seeking equity financing or debt to fund operations in addition to taking concrete steps towards conserving capital it will need operate in the second quarter of 2011.