I agree that B-OM is a very approvable indication due to its safety profile and its effectiveness. I have also observed some concerning FDA behavior. Sarepta has a drug that was showing efficacy for duchenne muscular dystrophy in boys but the trial was small. Nevertheless, the boys in the trial that were able to walk when the trial started were still walking some 5 years later and natural history data suggested the majority should not be. Some at the FDA did not want the drug approved and tried to use incorrect statistics to deny it. Janet Woodcock overruled everyone and gave it accelerated approval over a year ago and took into account the patient reported outcomes that were being touted by a few very determined parents. Many boys are now on the drug and are seeing continued proof that it works and works well. The safety profile is spotless. Boys with this disease usually cannot walk by age 12-13 and many die due to respiratory muscle weakness in late teens or early 20s. I never imagined that politics and power would take precedence over the well being of children....it was an eye opener for me and I hopefully wont be as naive as I was before.