EpiCept Corporation (OTC:EPCT) announced late on Monday it had sent a Market Authorization Application [MAA] with the European Medicines Agency for the approval of Ceplene.
Ceplene is EpiCept's lead oncology product that is administered with Interleukin-2 for first remission in Acute Myeloid Leukemia patients.
The odds look good for approval as the European Agency had already designated Ceplene Orphan Drug Status, and phase 3 results had met critical endpoints.
CEO Talley believes the market potential for Ceplene in the European Union alone can exceed $300 million.
Shares of EpiCept were already up 18% in pre-market trading.