- The FDA sends Pozen (NASDAQ:POZN) a CRL on its drug candidates PA8140/PA32540 (apirin and omeprazole). During an on-site inspection of an ingredient maker, agency representatives noted deficiencies that need to be resolved before the NDA may be approved.
- No safety or clinical deficiencies regarding the products are noted.
- The company believes it can remedy the situation to the FDA's satisfaction although the CRL will extend its PDUFA date.
- Management hopes to be able to provide additional information during its May 8 earnings call.
- Shares are off almost 18% premarket on mediocre volume.