Sunday, January 24, 2010

Sixty Days and Counting for Somaxon Pharma's Silenor

Somaxon Pharmaceutical’s (SOMX-$2.40), acknowledgement of a Class 1 Response for its insomnia drug Silenor indicates a receptiveness by health regulators to complete the drug review within a 60-day period. As companies — including Somaxon — do not disclose contents of complete-response letters, it is difficult to interpret the material intentions of the FDA. Nonetheless, Class 1 resubmissions typically address just small deficiencies in the application, such as labeling or a minor re-analysis of previously submitted data to the application, according to Center for Drug Evaluation and Research procedures. Read More….

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

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