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Cipher reports third quarter fiscal 2007 results
Date:11/7/2007

eeks to build its presence in the important primary care space.

During the second quarter of 2007, Cipher received a second approvable letter from the FDA pertaining to its CIP-ISOTRETINOIN NDA. In the letter, the FDA indicated that Cipher's application is approvable subject to the resolution of two remaining issues. In addition to one question related to chemistry, manufacturing and controls, which the Company has responded to, the FDA has requested that Cipher provide additional clinical safety data. The Company appealed the position taken by the FDA in its approvable letter using the formal dispute resolution process. Cipher submitted its appeal and met with the FDA on July 11, 2007. In August 2007, the Company received a response from the FDA to its request for formal dispute resolution. In the letter to Cipher, the representative from the FDA agreed with the Division of Dermatology and Dental Product's view that a clinical study is needed to further demonstrate the safety of CIP-ISOTRETINOIN. Subsequently, Cipher has had further discussions with the FDA on the issues raised in its response letter. Cipher continues to believe that the clinical questions raised by the FDA have been addressed in the NDA submission. The appeal process is ongoing.

During the second quarter of 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's once-daily formulation of tramadol. In its letter, the FDA indicated that Cipher's application is approvable subject to the resolution of certain issues, including a request for an additional adequate clinical trial to provide further efficacy data. In subsequent discussions with the FDA, Cipher has obtained clarification on the question of efficacy. The FDA has indicated that the statistical methods used to analyze data from Cipher's clinical trials did not adequately address missing data relating to subjects who dropped out of the trials. The Company has a meeting sched
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SOURCE Cipher Pharmaceuticals Inc.
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