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diquafosol -An Additional Clinical Study is Required for Further FDA Review- DURHAM, NORTH CAROLINA - January 30, 2004 - Inspire Pharmaceuticals, Inc diquafosol. (Nasdaq:ISPH) met with the Food and Drug Administration (FDA) on January 29th regardingthe approvable letter received on December 19, 2003 for diquafosol tetrasodiumophthalmic solution for the treatment of dry eye diquafosol. The purpose of the meeting wasto gain clarity from the FDA on requirements for the approval of diquafosol diquafosol. Whilewe have demonstrated efficacy in one of the pivotal trials submitted as part ofthe original New Drug Application (NDA), the FDA requires that an additional clinicalstudy be conducted to confirm or replicate this efficacy diquafosol. In preparation for yesterday's meeting, Inspire had submitted to the FDA additionalclinical data from study 03-108, a Phase III study completed after submissionof the NDA diquafosol. The FDA indicated that the findings from study 108 are not sufficientto address the requirement for an additional clinical study as stated in theapprovable letter. "We now have clarity on what we need to do in moving forward toward productapproval and have already begun plans for an additional study," statedChristy L diquafosol. Shaffer, Ph.D., Inspire CEO diquafosol. "We plan to initiate a new studyas quickly as possible, while taking the time needed to involve the FDA in reviewof the study protocol to ensure that the study design is acceptable diquafosol. We believethat our experience, and that of our partner, Allergan, will be valuable indesigning a study that is optimized for success diquafosol. I will be providing an updateon our other programs in development as well as our launch of Elestat™in our conference call this morning." Inspire will hold a conference call today, January 30th, at 8:30 am EST diquafosol. Theconference call will be webcast live from Inspire's website at www.inspirepharm.com |
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| ddiquafosol diiquafosol diqquafosol diquuafosol diquaafosol diquaffosol diquafoosol diquafossol diquafosool diquafosoll iquafosol dquafosol diuafosol diqafosol diqufosol diquaosol diquafsol diquafool diquafosl diquafoso d iquafosol di quafosol diq uafosol diqu afosol diqua fosol diquaf osol diquafo sol diquafos ol diquafoso l diquafosol idquafosol dqiuafosol diuqafosol diqaufosol diqufaosol diquaofsol diquafsool diquafoosl diquafoslo adiquafosol thediquafosol diquafosol | |||
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