Business
US and EU Clinical Development Plans
US and EU Clinical Development Plans.
About this update from Talisman Metals Plc
[{"type":"text","content":"\n \nRNS Number : 7071W Ovoca Bio PLC 23 April 2019 \n\nOvoca Bio plc\n(\"Ovoca\" or the \"Company\")\n \nUS and EU Clinical Development PlanS\n \nOvoca Bio plc (LSE: OVB; ISE: OVXA) is pleased to announce that its subsidiary IVIX LLC (\"IVIX\") has commenced the process of preparing an integrated Clinical Development Plan (\"CDP\") for its investigational drug candidate, Libicore (BP-101), for both the US and EU regions with Biorasi LLC (\"Biorasi\"), an experienced US-based contract research organization. \nThe Medical and Scientific Affairs team from Biorasi will lead the preparation of the integrated CDP for inclusion in the clinical section of the submission dossiers under the Scientific Advice procedure at the German Federal Institute for Drugs and Medical Devices (BfArM) and for a pre-IND (Investigational New Drug) meeting process with the US FDA. During consultations with these regulatory agencies, it is planned to review pre-clinical and clinical data, and manufacturing operations for BP-101, and to gather the agencies' comments on the proposed development program and study design. It will be an important step for the program to confirm BP-101 development plans that will be acceptable in Europe and the US. \nDaniil Nemenov, General Director of IVIX, commented: \"Preparation of a smart clinical development program for our compound which is compliant with both US and EU regulatory requirements, is one of the most critical components of our strategy to pursue these attractive markets. We are pleased to undertake this work with Biorasi, considering their extensive experience in this area.\" \nBoris Reznik, chairman of Biorasi added: \"We are very excited to begin this project with Ovoca/IVIX. Their BP-101 drug candidate has shown promising performance in clinical trials so far, and we believe there is high potential in bringing it over to the EU and US markets.\"\n \nFor further information: \nOvoca Bio plc \nKirill Golovanov (Chief Executive)\nTel +7 495 916 6029\[email protected]\n \nDavy (Nominated Adviser, Euronext Growth Advisor and Broker)\nJohn Frain / Daragh O'Reilly\nTel: +353 1 679 6363\n \nAbout Ovoca Bio plc \nOvoca Bio plc's goal is to become a leader in the development and commercialization of novel product candidates for the treatment of female ...