Combigene and Spark Therapeutics Plan to Expand the Clinical Development Program to Include the U.S. as Well as Europe
The most significant outcome of this review is the decision to expand the clinical development program to include clinics in the U.S. as well as in Europe. The U.S. is the world's pharmaceutical market and to establish a clinical presence there adds much further strength to the CG01 project. In order to prepare CG01 to meet the needs of a global submission the remaining preclinical program will be expanded and, in some parts, complemented with additional studies. In practice, this means that the preclinical part of CG01 will take longer to finalize.