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Chelsea Therapeutics, Inc. (CHTP) Might Seek Limited Northera Approval, Meets With FDA This Month


5/3/2012 7:53:50 AM

Chelsea Therapeutics (NASDAQ:CHTP) won’t meet with regulators until later this month to discuss its orphan drug Northera but the company is already staking out scenarios of a more limited approval for the drug. If results of an ongoing phase 3 study don’t support the durability of Northera’s effect over time, the company said in its quarterly filing that it “might seek to obtain approval for Northera as an acute rather than a chronic treatment.” That change, detailed in an updated list of risk factors for the company, would further limit use of a drug that was already intended for a narrow patient population.

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