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Chelsea Therapeutics' CEO Discusses Chelsea Therapeutics Receives Complete Response Letter From Food And Drug Administration For Northera(TM) (droxidopa) Capsules (Transcript)

Stocks in this article: CHTP

Following formal remarks by Dr. Pedder, the conference call will be open for questions. Now before I turn the call over to Dr. Pedder, let me note that some of the remarks that you will hear today may contain forward-looking statements about the company's performance, actual future results might differ materially from those projected in the forward-looking statements. Additional information concerning these factors that could cause actual results to materially differ from those in these forward-looking statements contained in our SEC filings and periodic reports under the Securities and Exchange Act of 1934 as amended, copies of which are available on our website or may be requested directly from the company. And with that said I'll turn the call over to Dr. Pedder.

Dr. Simon Pedder

Thank you Kate and thanks to everybody for joining our call today. As we announced late yesterday, the US Food and Drug Administration has issued a complete response letter related to our new drug application for Northera also known as droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension or NOH. This morning we would like to take you through each of these issues identified in last night's press release and answer questions you may have regarding the complete response letter or our path forward. Before we get into detail of the agency's response I would like to remind everyone that while we have had the opportunity to review the letter in detail, we of course have not had the opportunity to follow up or speak to anyone at the FDA.

In that respect some of our discussion will involve speculation until we consult with the agency on their recommendations. While the complete response letter identified several requests and recommendations, the principle request and the one with the greatest impact for Chelsea was the request for an additional efficacy data to support the findings of our pivotal study, Study 301 and to demonstrate the durability of effect the over a two to three-month period. The complete response letter detailed the agency's guidelines for an approval based on a single persuasive study and highlighted that Study 301 was positive and achieved a typically persuasive outcome on the OHQ, Orthostatic Hypotension Questionnaire.

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