Ventrus Biosciences Inc. (VTUS), a pharmaceutical company focused on developing and commercializing gastrointestinal products, Monday said that following the completion of a second phase 3 study, it expects to file a new drug application for diltiazem hydrochloride cream (VEN 307) in anal fissures. This decision comes after a written feedback from the U.S food and drug administration.
The company has started to indulge in the second phase 3 pivotal trial, the results of which are expected in early fourth quarter 2013. Assuming a positive outcome, it expects to file an NDA late in the fourth quarter of 2013 with an anticipated PDUFA date at the end of 2014.
Friday the stock closed at $3.07 on the Nasdaq.
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