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FDA Requests Additional Study for Diquafosol Review
In preparation for yesterday's meeting, Inspire had submitted to the FDA additional clinical data from study 03-108, a Phase III study completed after submission of the NDA. The FDA indicated that the findings from study 108 are not sufficient to address the requirement for an additional clinical study as stated in the approvable letter.
"We now have clarity on what we need to do in moving forward toward product approval and have already begun plans for an additional study," stated Christy L. Shaffer, Ph.D., Inspire CEO. "We plan to initiate a new study as quickly as possible, while taking the time needed to involve the FDA in review of the study protocol to ensure that the study design is acceptable. We believe that our experience, and that of our partner, Allergan, will be valuable in designing a study that is optimized for success."
Source: Inspire Pharmaceuticals, Inc.