The FDA given an approval letter to Huntingdon Valley, PA-based Cellegy for its ointment Cellegesic. The company must conduct another trial of Cellegesic in order to demonstrate statistically significant effectiveness. Cellegy interim CEO Richard C. Williams stated that the company had proven the ointment effective. "The FDA reached a different conclusion... We are carefully considering all of our options and will be scheduling a meeting with the FDA." Shares dropped 32 percent this morning to 44 cents.
- see this press release for more