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In a release, the Company noted that the FDA identified two deficiencies in the Complete Response Letter and recommended that the following information be provided to the FDA to address these clinical deficiencies: (i) results of a second adequate and well controlled Phase III trial demonstrating the safety and efficacy of toremifene citrate 80mg to reduce fractures in men with prostate cancer on ADT and (ii) results from an adequate and well-controlled clinical trial demonstrating that toremifene treatment to reduce fractures in men with prostate cancer on ADT does not have a detrimental effect on either time-to-disease progression or overall survival. GTx is requesting a meeting with the FDA to determine the appropriate next steps regarding the NDA.
GTx, Inc. is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to prevent and treat cancer, fractures and bone loss, muscle loss and other serious medical conditions.
((Comments on this story may be sent to health@closeupmedia.com))
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