Dynavax Technologies (DVAX) is expecting a Prescription Drug User Fee Act (PDUFA) date of February 24th for its hepatitis B vaccine Heplisav. Basically, this means the FDA will decide on or before this date whether or not to approve the drug.

Hepatitis B is an infectious inflammatory illness of the liver caused by the hepatitis B virus (HBV). The disease has caused epidemics in parts of Asia and Africa, and it is endemic in China. About a third of the world population has been infected at one point in their lives, including 350 million who are chronic carriers.

Needless to say, the market is large for a drug like Heplisav. Many biotech analysts and writers believe the drug will be approved. The real question is whether or not the FDA will place certain restrictions on the drug, such as patient age and dosing restrictions. Also worth considering is last November's advisory committee safety vote on the drug, which was 5-8 against. This prompted Jeffries to lower its price target from $6 to $5, with the analyst firm still rating the stock a "buy."

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