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Chelsea Therapeutics' CEO Presents FDA Advisory Committee Update - Conference Call (Transcript)

Before I turn the call over to Dr. Pedder, let me note that some of the remarks you’ll hear today may contain forward-looking statements about the company’s performance. Actual future results might differ materially from those projected in these forward-looking statements. Additional information concerning factors that could cause actual results to materially differ from those in these forward-looking statements is contained in our SEC filings and periodic reports under the Securities and Exchange Act of 1934 as amended, copies of which, of course, are available on our website or may be requested directly from the company.

And with that said, I’m going to turn the call over to Dr. Pedder. Go ahead, Pedder.

Simon Pedder

Thanks, Kate, and thanks to everybody for joining the call today. As we announced earlier today, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 7-4 with 1 abstain and 1 non-voting to recommend approval of NORTHERA, also known as droxidopa, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, a group of diseases that include Parkinson’s disease, multiple systems atrophy and pure autonomic failure.

All pivotal studies showed that NORTHERA improved a broad range of Neurogenic OH symptoms, including dizziness, standing systolic blood pressure, and ability to perform activities of daily living. And clinical studies have shown that NORTHERA is safe and well tolerated in this chronically ill population.

So, we were pleased to have this discussion with the FDA. We believe we had a thoughtful, fruitful discussion on key issues. For those who could not attend or listen to the meeting, we had a good discussion on endpoints to characterize the treatment effect. We appreciated the type and scope of the questions from the panel, especially how to capture symptomatic benefit in this patient population.

Certainly, we have a lot to learn in accepting symptomatic benefit in these patients. The panel was similarly interested in understanding the clinical benefits seen in our clinical trials. The unmet medical need weighed heavily on their discussions as did the lack of effective treatment alternatives and severity of the underlying condition. All of you can appreciate the challenges going into this meeting given the emphasis placed on safety concerns in the FDA briefing document.

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