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RepliCel Life Sciences Conducts Formal Consultation Review With Japan's PMDA and Receives Unprecedented Review Fee Reduction
RepliCel Life Sciences Conducts Formal Consultation Review With Japan's PMDA and Receives Unprecedented Review Fee Reduction.
About this update from Replicel Life Sciences Inc.
[{"type":"text","content":"\n \n \n RepliCel Life Sciences Conducts Formal Consultation Review With Japan's PMDA and Receives Unprecedented Review Fee Reduction\n \n \nRepliCel Life Sciences Conducts Formal Consultation Review With Japan's PMDA and Receives Unprecedented Review Fee Reduction\n\nJapan's Pharmaceuticals and Medical Devices Agency reviews RepliCel's pre-clinical, quality, and manufacturing data for its non-bulbar dermal sheath (NBDS) platform\n\n \n VANCOUVER, BRITISH COLUMBIA--(Marketwired - Apr 25, 2016) - RepliCel Life Sciences Inc. (OTCQB:REPCF)(TSX VENTURE:RP)(FRANKFURT:P6P1), a clinical stage regenerative medicine company focused on the development of autologous cell therapies, announced that it met this month with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in Tokyo. The meeting was a formal consultation review of the company's pre-clinical, quality, and manufacturing data related to its non-bulbar dermal sheath (NBDS) platform technology. This review is a required step in the process to obtain PMDA consent to perform a clinical trial in Japan. \n \"We have been very encouraged by the PMDA's collaborative approach and yet the absolute high standards of safety they maintain,\" stated R. Lee Buckler, President & CEO, RepliCel Life Sciences Inc. \"The conduct of this consultation meeting moves the clinical-stage products (RCT-01 tendon repair; RCS-01 skin rejuvenation) being developed from our NBDS platform closer to the launch of Japanese clinical trials and partnerships,\" he added. \n Furthermore, each consultation performed by the PMDA at the formal request of a potential clinical trial sponsor, carries with it associated fees which are lowered for academic institutions, hospitals, and small/medium enterprises. Additionally all documentation created for the consultation must be provided in Japanese. \n Without any known precedent for doing so, RepliCel, on the advice of CJ Partners Inc., applied for the reduced-fee designation based on its small size and the pre-revenue nature of its business. The company was successfully awarded a reduced fee status which represents approximately one-tenth of the otherwise applicable fees.\n \"To the extent that CJ Partners knows, this is the first time that a foreign regenerative medicine company has qualified for the reduced price status with the PMDA,\" commented Colin Lee Novic...