Shares in GW Pharmaceuticals (GWPH) jumped substantially after the company announced that its epilepsy drug epidiolex received fast track designation.
While the designation sounds good -- who doesn't want faster drug approvals? -- fast track designation is relatively easy to get and says more about the unmet need of the disease the drug treats than it does about the drug itself. In GW Pharmaceuticals' case, epidiolex is being studies as a treatment for a rare, childhood epilepsy called Dravet syndrome that is fairly resistant to current treatments.
Fast track allows companies to have more meetings with the FDA and a rolling submission, but the benefits don't seem to be speeding up the process very much considering how many drugs are approved on their PDUFA dates. In the video below, senior biotech specialist Brian Orelli and health-care analyst David Williamson speculate that the designation could be keeping companies from further delays, but it's impossible to quantify.
Watch the video below for more on GW Pharmaceuticals and how investors should value fast track designation.
