They further acknowledged that that their guidance is open to the possibility of a single study approval in indications which there is an unmet serious medical need. And that NOH as a condition which is still [awaiting] symptoms with limited treatment options could be a condition for which they will consider an approval based on the results of one study. The letter also states that 301 has many of the characteristics of a single adequate well-controlled study that could make it adequate to support effectiveness.However the agency's review of the data concluded that there were some subgroups namely women, older patients, US patients and those with Parkinson demonstrated less persuasive results following treatment with Northera and I will note separately that a majority of 301 was conducted in Ex US and that a majority of the US patients participating in the study were through consultation.
Chelsea Therapeutics' CEO Discusses Chelsea Therapeutics Receives Complete Response Letter From Food And Drug Administration For Northera(TM) (droxidopa) Capsules (Transcript)
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