What is the true chance of approval here? The chart long term is horrible. sure looks like its owned by some inst. investors. My etrade acct shows like 56.80 pct owned. I need a big winner in my pocket, Is this it? Thanks Green
Epicept-Ceplene (1-2 billion sales - World wide) Decision from EMEA(EU) in april/may 2007 Filing for a FDA approval later this year.
October 9, 2006 EpiCept Files for Marketing Approval of Ceplene(TM) in European Union
Ceplene is EpiCept's lead oncology product that is administered with Interleukin-2 for first remission in Acute Myeloid Leukemia patients. Indication is a form of leukemia called AML. VERY strong phIII data in a big randomized study that met the prim endpoints and had high stat significance! They have already got the "day-120 list" from the agency with questions and a f"irst conclusion" under the central procedure anf they were very positive.
CEO Jack Talley: 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.
According to analysts in Sweden 80% chance of getting approved by EMEA, see link www.nordiceyes.com
Epicept-Azixa (2-3 billion - World wide) Cancer drug - primary and metastatic brain cancer There are approximately 170,000 new cases of metastatic brain tumors in the United States each year, and this number has risen steadily.Patients with glioblastoma multiforme (GBM) will be treated with Azixa, Azixa and oxaliplatinterm, or oxalplatin alone and compared for survival rates. The 5 year survival rate of GBM stands at <3% and has remained unchanged for over 30 years. One problem with present cancer drugs is they cannot pass the blood-brain barrier (BBB) in efficiently high doses to act on the cancer. The BBB is the layer of tightly packed endothelial cells surrounding the brain preventing high-molecular weight molecules from entering the brain. Here is a quick reference to a good definition of the blood-brain barrier. Azixa has been shown to cross the BBB and has two anti-tumor functions. It acts as a cytotoxin and a vascular disrupting agent. It inhibits microtubule formation in cells and in the new blood vessels being formed in the tumor to supply it with nutrients.Ongoing phase 2 trials,50-70 centers in both the United States and Europe.
Fast track admission FDA- hit the market in 2008 (The 5 year survival rate of GBM stands at <3% and has remained unchanged for over 30 years)