Cardio3 BioSciences milestone in regulatory path for C-Cure registration in EU

3 March 2015

Belgian cell therapy specialist Cardio3 BioSciences (C3BS; Euronext Brussels: CARD) has received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency for C-Cure, the Company’s lead product-candidate currently in Phase III clinical development for the treatment of ischemic heart failure.

As part of the regulatory process for the registration of new medicines with the EMA, drugmakers are required to provide a Pediatric Investigation Plan (PIP) outlining the company’s strategy for investigation of the new medicinal product in the pediatric population. In some instances, a waiver from developing a PIP for certain conditions may be granted by the Agency.

Product-specific waiver

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