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Chelsea Therapeutics International Ltd Wins Huge Vote of Confidence. Can It Stop Another FDA Rejection?

By Dave Williamson – Jan 15, 2014 at 7:00PM

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Chelsea wins another advisory committee, but will Northera's fate be any different?

Chelsea Therapeutics (Nasdaq: CHTP) was nearly an instant double as shares closed up 92% today after receiving a positive advisory committee vote for its NOH drug Northera.
The trading action would lead investors to conclude it was a blowout, and in FDA advisory committee terms it was, a 16-1 decision recommending the agency approve the drug.
Before investors get too excited, remember Chelsea has been here before. This is not Northera's first trip in front of the FDA. Its not even Northera's first trip with a positive advisory committee vote in hand. That didn't stop it from its most recent rejection. And the FDA seemingly has not warmed up to the drug; a large part of today's gain was just making up for the 29% plunge that happened when the FDA's briefing documents came out ahead of the advisory panel.
In this video, Motley Fool health care analyst David Williamson discusses the FDA biggest concern about Northera, why Chelsea's balance sheet is a big problem, and whether he thinks the drug will be approved on, yes, Valentine's day.

David Williamson has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. We Fools may not 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.

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