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January 18, 2016
Sponsor Fee Waiver for FY 2016 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 2016.
After the first positive decision in 2015, FDA decides to also grant a sponsor fee waived for FY 2016 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.