Chelsea makes me sad. I believe Northera is an effective and beneficial drug for neurogenic orthostatic hypotension (NOH) patients but the drug is trapped, unfortunately, in FDA review purgatory by an incompetent management team. Chelsea isn't likely to recover until the company and FDA reach an agreement on how to collect the clinical data necessary to get Northera approved.
At this point, it's a legitimate question to ask if Chelsea's current management has the capability of finishing the job they've bumbled so badly to date. FDA should shoulder some of the blame for being recalcitrant with a drug that received a positive vote from an outside advisory panel, even if the margin of victory was small. Still, Chelsea's problem stems mainly from management's decision to amend -- and amend again and again -- the Northera clinical trials to the point where data collected are impossible to interpret.
--Written by Adam Feuerstein in Boston.
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