- In March 2012, the Company announced the results from two phase 1 clinical studies requested by the U.S. Food and Drug Administration (FDA) in its Complete Response Letter for APF530. The results of these studies will be included in the resubmission of the New Drug Application (NDA).
- The Company completed a thorough QT study for APF530 showing that granisetron, the active drug used in APF530, does not have an effect on cardiac repolarization as measured by prolongation of the QT interval.
- A separate metabolism study was completed that showed how the human body processes APF530 and corroborated preclinical animal data.
- The Company is awaiting the review of its non-clinical human factors validation study protocol by the FDA and anticipates performing this study in the second quarter of 2012. The validation study protocol is based on previously completed formative studies, and the results will be included in the NDA resubmission.
- On March 26, 2012, the Company announced the appointment of Thomas Ottoboni, Ph.D. as Vice President of Pharmaceutical Development.
- On May 8, 2012, the Company received $3 million of cash through the issuance of convertible notes pursuant to a second closing of the private placement financing for up to $4.5 million announced in April 2011.
A.P. Pharma Announces First Quarter 2012 Financial Results And Recent Corporate Progress
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