FDA Requests More Info from Ventrus (VTUS) for VEN 309 SPA
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Ventrus BioSciences, Inc. (Nasdaq: VTUS), reports that it received a response from the U.S. FDA to its last Special Protocol Assessment (SPA) submission for iferanserin (VEN 309) for the treatment of hemorrhoids, and will update the protocol for the company's first pivotal trial for iferanserin and file it to its investigational new drug application (IND), so that the trial can start as planned.
In its response, the FDA requested that additional information be included in the protocol pertaining to certain details of the trial. None of these new recommendations affect the previous recommendations made by the FDA for the endpoints, overall statistical powering and subject number, and the overall clinical design of the trial. Ventrus agrees with all of these new recommendations and will update the protocol accordingly and submit it to the IND.
In its response, the FDA requested that additional information be included in the protocol pertaining to certain details of the trial. None of these new recommendations affect the previous recommendations made by the FDA for the endpoints, overall statistical powering and subject number, and the overall clinical design of the trial. Ventrus agrees with all of these new recommendations and will update the protocol accordingly and submit it to the IND.
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