SAN DIEGO--(HSMN NewsFeed)--Jan. 18, 2005-- Maxim Pharmaceuticals, Inc. (Nasdaq:MAXM ; SSE:MAXM) today announced that based on ongoing correspondence with the United States Food and Drug Administration (FDA), as well as consultations with external advisors, an additional Phase 3 clinical trial will be necessary to further evaluate Ceplene plus Interleukin-2 (IL-2) combination therapy for the treatment of acute myeloid leukemia (AML) patients in complete remission before applying for regulatory approval in the United States. In May 2004 Maxim announced that its Phase 3 clinical trial studying Ceplene plus IL-2 therapy in 320 AML patients in complete remission met its primary endpoint, improvement in leukemia-free survival. Maxim will continue discussions with the FDA regarding trial design, however, given the time and costs required to conduct another Phase 3 clinical trial, the Company believes that such trial would need to be done in collaboration with a corporate partner, and Maxim intends to pursue partnering opportunities in the United States related to Ceplene for the treatment of AML. Maxim is continuing discussions with European Regulators to determine if an additional Phase 3 clinical trial is necessary for European regulatory approval. The Company will continue to evaluate strategic options related to the above outcomes.
The FDA has already rejected this data as approvable. Better be careful!
The endpoint are acceptable. Doesn't mean they have been met yet in relation to IL-2 alone (which of course, wasn't done). Again I'm not bashing guys and I'm certainly not going to short a stock with very little downside.
You are nothing but a liar and a shorter and I always back up my statements with facts, I can't see you doing that.
I have one big question for you shorter,why did EMEA accept the primary endpoints for the phase III study in Feb this year, please read this official press statement regarding Epicept and Ceplene
European Medicines Agencyfor the Evaluation of Medicinal Products (EMEA). During a March 1,2007 oncology program update conference call, EpiCept reported that the
application review is proceeding according to expectations. Notably,the Company reported that the EMEA has accepted the primary endpoint of an improvement in disease-free survival, in the Company's caseleukemia-free survival, as the basis upon which to approve a candidate drug.