In the E.U., the designation means 10 years of market exclusivity. It is anticipated that a sustained release formulation for that combination, which is currently being tested, will be approved in the future. The Company has been investigating several other antivirals and slow release formulations. This would potentially be via an IND route in the U.S. or under the existing CTX in the U.K. Subject to certain considerations, it is likely that a clinical trial application will be made during 2000. Certain material may be the subject of patent applications and, therefore, should not be made public prior to the issuance of the patent.
Patents can take several years to issue.
Other material may be covered by confidentiality agreements or may be bound by the terms of specific license, collaborative or other legal agreements. Anything considered to be substantively useful to any competitor would also be withheld. Additionally, the Company must comply with the SEC s rules and regulations that were purposely designed to prohibit the dissemination of preliminary or incomplete data that could prove to be misleading in the future or stimulate demand from patients for treatment for yet unproven indications. The multi-faceted effort is designed to effectively communicate the Company s achievements as well as its exciting future prospects. Each entity will focus on enhancing Viragen s exposure within a particular market.