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Chelsea Therapeutics International, Ltd. (CHTP)

Completion of EoR Meeting with FDA for Northera Capsules NDA

May 23, 2012 8:30 AM ET


Kathryn McNeil – Head-Investor & Media Relations

Simon Pedder – President & CEO

Nick Riehle – VP-Administration and CFO

Bill Schwieterman – Chief Medical Officer

Art Hewitt – Chief Scientific Officer


Robyn Karnauskas – Deutsche Bank Securities, Inc.

Alan Carr – Needham & Company

Liana Moussatos – Wedbush Securities, Inc.

Juan Sanchez – Ladenburg Thalmann Securities.

Steven Salamon – ROSALIND Advisors


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Good day ladies and gentlemen, and welcome to the Chelsea Therapeutics May 22 Conference Call. At this time, all participants are in a listen-only mode. Later, we’ll conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions)

As a reminder this conference is being recorded.

I would now like to turn the call over to your host, Kathryn McNeil. Please go ahead.

Kathryn McNeil

Thank you operator. Good morning everyone and thank you for joining us for our call this morning. A press release related to today’s call can be found on our website,

Joining me from Chelsea this morning is Simon Pedder, our President, Chief Executive Officer, Mr. Nick Riehle, our Chief Financial Officer, Dr. Bill Schwieterman, Chief Medical Officer and Dr. Art Hewitt, Chief Scientific Officer.

Following formal remarks by Dr. Pedder, the conference call will open for questions. However, before I turn the call over to Dr. Pedder to get us going, let me note that some of the remarks you’ll hear today contain forward-looking statements regarding future events including our intention to modify the primary endpoint for Study 306B, submit additional data to the FDA, resubmit the NDA for the treatment of Neurogenic OH, anticipated expenses for 2012, cash levels and liquidity to fund the company’s operating plans and the company’s anticipated performance.

Actual events might differ materially from those projected in this forward-looking statement. Additional information concerning factors that could cause actual results to materially differ from those in this forward-looking statement contained in our press release issued today, our most recent 10-Q and 10-K filed with the SEC, which are available on the SEC and other public websites including our own or they can be requested directly from the company.

And as that said, I’ll turn the call over to Dr. Pedder. Go ahead Simon.

Simon Pedder

Thanks Kate and good morning everyone. I’d like to thank you for joining us on our call this morning and also thank you for your patients as we held our hosting our call this quarter until we had completed our meeting with the FDA, and received official meeting minutes from the agency.

The primary purpose of this call is to provide you with an update of our interactions with the FDA subsequent to the receipt of the Complete Response Letter for our Northera New Drug Application in March.

However, as we did not host a conference call in conjunction with the release of our first quarter operating results and because our clinical and regulatory strategy for Northera impact or forecast. I will also ask Nick to provide you with a brief review of our financials and share with you some update guidance prior to opening the call for your questions.

Before we get into a detailed discussion, I would like to point out that quite a lot of transpired since we received the Complete Response Letter from the agency including written and verbal communications prior to our meeting, the meeting itself and of course receipt of official FDA minutes from the meeting. It is important to note that we have not completed our discussions with the FDA or reached a final agreement with them regarding plans to provide additional clinical efficacy data for our Northera NDA.

Collectively however, the interactions we have had to date with the FDA have been productivity and meaningfully informed our thinking and our strategy to moving forward with our NDA. In this regard, some of our discussion today will not only involve information and feedback contained in our written communication with the agency, but also some speculation and conclusions drawn from on interaction to date as well.

As we detailed in our last call and today’s press release, the Complete Response whether we received in March included the request that we submit data from an additional positive study to support the efficacy demonstrated in Study 301 and the recommendation that such a study be designed to demonstrate durability of affect over two to three months period.

As we reported to you at the time the Complete Response Letter from the agency, noted several concerns related to the impact of our highest enrolling clinical site on the overall study results. The FDA noticed that these results had a disproportionate positive effects on the outcome of the trough and that if you exclude these patients from the study analysis, while still positive the results will less decisive.

Because of this consent, the FDA could not accept Study 301 alone as sufficient efficacy as – as a significant evidence of efficacy for approval. Since the FDA has never previously raised any questions or concerns about this particular center and because there had been two independent site visits as well as the successful FDA audit of this site during the NDA review. We initially interpreted that concerns related to the site in the context of our seeking approval based on the outcome of the single pivotal study and the associated FDA guidance for a single study approval outlined in the Complete Response Letter specifically that said no single site should provide an unusually large fraction of the patients and no single investigator or site should be disproportionately responsible for the favorable affect seen.

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