Modafinil's NDA has an excellent chance of approval..eventually. Since it is a novel chemical class for the treatment of narcolepsy, the FDA will most likely request that the Advisory Panel responsible for CNS drugs review it. Now there's the proverbial rub: that Advisory Panel, and Paul Leber, who is the FDA Division chief responsible for CNS, have no love lost for CEPH due to Myotrophin. My opinion regarding Myotrophin's prospects is well documented elsewhere and does not need to be repeated here. Since Modafinil is being presented for a non life threatening condition for which treatment, however imperfect, is available, there is absolutely no basis for any fasttracking of Modafinil. Indeed, I would expect to see all scheduling of regulatory reviews of Modafinil to occur with the same speed as the balancing of the federal budget (OK, that is a slight exaggeration). The FDA may well be forced to approve Myotrophin, and Modafinil's data may be sufficiently convincing that approval will have to be given. However, the speed of processing, and the amount of nitpicking hurdles thrown in the path, are variables that are firmly under FDA (and the advisory
panel) control. CEPH is going to be punished for having 'dissed' the agenda of the FDA, and this is where they will pay the price. If the Advisory Committee reviews this drug in 1997, I will consider that a minor miracle. No, a major miracle. NeuroInvestment |
