Chelsea Therapeutics' (NASDAQ: CHTP ) drug Northera has its Prescription Drug User Fee Act, or PDUFA, date on Friday. The drug treats dizziness and fainting in people with diseases like Parkinson's.
The FDA remains somewhat skeptical about the durability of efficacy of the drug, according to briefing documents, even though an advisory committee voted 16-to-1 in favor of approval. The company has, however, received a similarly positive vote before, and still came up against FDA rejection, so an advisory committee vote does not mean certain approval.
The drug has been sold for decades in Japan, but in this video from Wednesday's Market Checkup, Motley Fool health-care analyst David Williamson says that he's not sure ultimately how the FDA will decide on this one. It could go either way, and is a situation he's going to be monitoring very closely.
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