Chelsea Therapeutics' (UNKNOWN:CHTP.DL) 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.
David Williamson and The Motley Fool have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.