Research analyst, medium-term horizon, biotech, small-cap

Orphan Designation A Game-Changer For DARA

Last November 2012, DARA Biosciences (DARA) announced it has submitted an application to the U.S. FDA requesting Orphan Drug designation on KRN5500 for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN). It's been over a year since that submission, and that may scare some investors into believing all hope is lost. After all, the FDA's own target for responding to Orphan Drug applications is 75 days, and so far in 2013 91% have been under 90 days. But we know for a fact that DARA and the FDA have been going back and forth on the application. We believe this is because of the overall size of the CCIPN market.

We discuss this below, and conclude that the

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