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CHTP > SEC Filings for CHTP > Form 8-K on 20-Feb-2013All Recent SEC Filings

Show all filings for CHELSEA THERAPEUTICS INTERNATIONAL, LTD. | Request a Trial to NEW EDGAR Online Pro

Form 8-K for CHELSEA THERAPEUTICS INTERNATIONAL, LTD.


20-Feb-2013

Other Events


Item 8.01 Other Events.

As described in a press release and Current Report on Form 8-K filed with the Securities and Exchange Commission on the date hereof, based on its plans to resubmit its Northera New Drug Application ("NDA"), Chelsea Therapeutics International, Ltd. (the "Company") has revised its expected timing for a new clinical trial of Northera, with the initial dosing now expected to begin in the fourth quarter of 2013 rather than the third quarter. As of December 31, 2012, the Company had cash and cash equivalents of approximately $28.4 million. Because of the improvement in the Company's cash position as compared with prior expectations and based on the revised date for commencing a new clinical trial, the Company now expects its existing cash reserves to finance its operations into the third quarter of 2014, rather than into the second quarter of 2014 as previous guidance indicated. In addition to the initial costs of a new clinical trial, this revised guidance assumes various costs related to the resubmission of the Northera NDA. No material additional activity related to or subsequent to a possible approval of Northera, nor to the commercialization of Northera should it be approved, has been included in this guidance.

Changes in the Company's research and development plans or other changes affecting the Company's operating expenses may affect actual future use of existing cash. The Company anticipates that the new clinical trial for Northera for which it plans to commence dosing in the fourth quarter of this year will not be completed until at least 2015 and therefore does not expect current cash reserves to be adequate to complete the study. The Company will continue to explore options for new capital, including various partnering and financing options.

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