Patient Population for the Clinical Trials of ITV-1 has been Established by the European Medicines Agency ("EMA") - Seite 2

The Company's therapeutic developments will include participation by many established pharm entities, including the following. VETPROM AD, a division of the French company Danhson, currently headed by Stanislav Stoev, Executive Director,represents over 65 years of continuous operations in the Bulgarian economy and is one of the largest pharmaceutical manufacturers of medicinal products (for human and veterinary use), food supplements and cosmetics in Bulgaria. VETPROM manufactures products under its brand name, as well as for third parties under contract manufacture agreements operating under accepted ISO 9001:2008 System for quality of management and the integrated system for Good Manufacturing Practice, under requirements of Volume 4, Good manufacturing practice (GMP) Guidelines.

The German Cooperative Clinical Grug Research and Development (CCDRD) is a contract research organization for clinical phase I-IV trials and will be performing the pharmacokinetics study on ITV-1 under the guidance and leadership of the CEO Rossen Koytchev, MD, PhD and Petra Kowalski PhD, Director of Business Development. CCDRD was founded in 1990 and has been performing clinical trials for over 30 years. The company is headquartered in Hoppegarten near Berlin, Germany.

The Center of Phytochemistry was set up as a joint project of the Bulgarian Government, UNDP, and UNESCO for scientific and applied research and training of specialists in organic chemistry and chemistry of natural products. The organization was renamed The Institute of Organic Chemistry with Centre of Phytochemistry (IOCCP) and is the leading scientific institution in t organic and bio-organic chemistry field in Bulgaria. VIRO has engaged IOCCP, represented by Prof. DSc Pavlina Dolashka, a member of its organizing committee and scientific committee to perform the biochem analysis of ITV-1 at the Bulgarian Academy of Science.

Documentation and correspondence that is required with the EMA as part of the permitting and application process will be performed for VIRO by Vili Topalova, MD EU QPPV Medical Director of AV Consult Pharm ("AVCP"). AVCP is a consulting company in the fields of Regulatory Affairs, Pharmacovigilance, Medical Devices vigilance, Cosmetovigilance, price and reimbursement and other consultancies for medical treatments. AVCP's expertise is based on years of experience with the Bulgarian Drug Agency (BDA) and the technical expertise of its employees - former experts and employees of the Bulgarian Drug Agency (BDA).