Business Context and Reporting Period
Pacira Pharmaceuticals, Inc. filed this Form 8-K on June 14, 2011, to report a regulatory event concerning its New Drug Application (NDA) for EXPARELTM (Bupivacaine Extended-Release Liposome Injection).
Key Financial Metrics
This filing is a Current Report regarding a specific event and does not contain financial statements. The filing text does not provide a clear value for revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes
The U.S. Food and Drug Administration (FDA) extended the Prescription Drug User Fee Act (PDUFA) goal date for the review of EXPARELTM by three months. The new PDUFA goal date is October 28, 2011. This extension occurred because the FDA requested additional information, which Pacira submitted as a major amendment.
Guidance, Outlook, and Risks
The filing indicates that the FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment within three months of the original goal date to allow time for review completion. No specific financial guidance or management commentary regarding future performance was included in this report.
Investor Verification Checklist
- Verify the new PDUFA goal date of October 28, 2011, for EXPARELTM.
- Confirm the nature of the "major amendment" submitted to the FDA.
- Monitor subsequent FDA communications regarding the approval status of the NDA.