Chelsea confident of FDA filing for hypotension drug Northera despite opting to alter design of key late-stage trial
This article was originally published in Scrip
Chelsea Therapeutics made a stab at putting a positive face on its plans for a two-pronged approach for filing applications with the US FDA for Northera (droxidopa) in symptomatic neurogenic orthostatic hypotension (NOH) – the result of changing the goal of a late-stage study. But investors were not convinced that regulatory risk was negligible, and sent the shares down as much as 23%.
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