The Company’s main current objectives are the following:
Establish commercialization and distribution partnerships for GVT® in Russia, select Commonwealth of Independent States (CIS) countries, and in select Central and Eastern European (CEE) countries, where approval currently exists in those territories for oncology, immunology, and anti-inflammatory indications
Establish development and commercialization alliances for the use of Bach's platform drug GVT® for initial indications including ataxia-telangiectasia (A-T) and Friedreich’s ataxia (FA) and obtain Orphan Drug Status at the FDA and EMEA (European Medicines Agency) for the use of the compound in patients with these and other rare diseases
Other near term objectives of the Company are as follows:
Secure INDs for ataxia-telangiectasia and Friedreich’s ataxia in 2011; commence clinical trials in A-T patients in conjunction with Children’s Hospital Boston / Harvard Medical School
Complete the Drug Manufacturing File (DMF) for the appropriate regulatory authorities
Obtain Orphan Drug Status at the FDA and EMEA (European Medicines
Agency) for the use of the compound in patients with ataxia-telangiectasia
(A-T) and Friedreich’s ataxia
Complete a Phase IIA Safety Study of Capsule Formulation of Bach’s platform drug GVT® in Humans under Radiation Treatment
