February 9, 2011 / 12:35 PM / 6 years ago

UPDATE 1-AP Pharma to meet FDA on nausea drug resubmission

2 Min Read

* Arranged meeting with FDA to clear doubts on lead product

* Seeks debt/equity financing to continue operations

* Met Nasdaq panel to discuss continued listing

Feb 9 (Reuters) - A.P. Pharma Inc APPA.O said it arranged a meeting with U.S. health regulators to clarify issues before resubmitting an approval application for its lead product, and is seeking financing to fund its operations beyond the second quarter.

Last March, the U.S. Food and Drug Administration declined to approve the drug, citing concerns regarding the drug's two-syringe administration system, and asked for more studies. [ID:nSGE62I0E7]

The company expects to determine the resources and timeline needed for resubmitting the new drug application for APF530 after the meeting, it said in a statement.

APF530 is being developed for the treatment of nausea induced by chemotherapy.

Separately, A.P. Pharma said it met with the Nasdaq Listing and Qualifications Panel after it received a letter in November stating it was subject to delisting. It is now awaiting the panel's decision on its eligibility for continued listing.

Shares of the California-based company closed at 52 cents Tuesday on Nasdaq. (Reporting by Rajarshi Basu and Krishnakali Sengupta in Bangalore; Editing by Sriraj Kalluvila)

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