The latest news: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Guidance for Industry This is a guidance document from the FDA which talks about what proof is now needed to get a new drug approved. It looks very favorable to the brain tumor community - there is a lot more flexibility than there used to be! Good work by the FDA. DelMar Pharmaceuticals Announces Peer-Reviewed Publication of Interim Results of Phase 2 Clinical Trial of VAL-083 As First-Line Treatment in Newly-Diagnosed MGMT-Unmethylated Glioblastoma Multiforme Val-083 is an experimental chemotherapy that is similar to Temodar but works on a different part of the DNA of the tumor, which the MGMT repair system can not repair. Theoretically, it should work in unmethylated MGMT patients as well as Temodar does with Methylated MGMT. This study hints that it is true. The study is really too small to tell, but does show an effect. BrainTumor Co-Payment Assistance Program Status: OPEN to new applicants