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April 3, 2017
Sponsor Fee Waiver for FY 2017 Granted by FDA
FDA grants GeneQuine Biotherapeutics a sponsor fee waiver under the significant barrier to innovation provision of ADUFA (Animal Drug User Fee Act) for FY 2017.
After the positive decisions in 2015 and 2016, FDA decides to also grant a sponsor fee waived for FY 2017 based on the assessment that GeneQuine Biotherapeutics is pursuing innovative drug products and technology with the development of gene therapy for treatment of osteoarthritis. This incentive supports GeneQuine’s development of innovative drugs and facilitates interactions and discussion with the FDA regarding the development and the regulatory process for GeneQuine's drug candidates towards marketing authorization in the US.