DARA BioSciences, Inc. (DARA)

[LaJollaCA]

According to Jason Napodano. ODS could be this month or early Feb.:

KRN5500 is a potential $250 million drug in CCIPN. The upfront payment alone from a potential interested party could double the shares. Research shows that Orphan Drugs do tend to succeed at higher rates than non-Orphan Drugs, and the FDA has stated a goal to respond to all applications in 75 days. DARA submitted a response to questions from the agency on September 10, 2013. Additional data was provided to the agency in November 2013. We expect a decision in the next month or two, and believe that could be a major catalyst for re-valuation at a higher level.



http://seekingalpha.com/article/1900351-orphan-designation-a-game-changer-for-dara


KRN5500 has mostly been an afterthought in our investment thesis that centers on the company's core commercial assets in Soltamox, Gelclair, and Bionect. However, Orphan Drug status for KRN5500 changes things - it creates enormous upside coming from the pipeline, as well as partnerships. A partnership is something that could come with a sizable upfront payment and development milestone that DARA can use to continue the expansion and stepped-up promotion of the commercial assets. We already rate DARA Bio a 'Buy' with a $1.50 target. Getting Orphan Drug designation for KRN5500 turns this potential triple into a home run. It's a beautify turnaround story in 2014, if it all comes together.