HotPennyStockNews.com is devoted to fetch you the most exclusive stocks in the market today. Apart from scanning the markets for the most underrated stocks. We propel those victors directly to your email inbox first ahead of the rest of the marketplace gets a prospect.
Los Angelas, CA -- (SBWIRE) -- 02/20/2013 -- Chelsea Therapeutics International Ltd. (NASDAQ:CHTP)'s shares more than doubled in value to $1.61 before the bell on Wednesday, as the company said it plans to file for approval for the drug in the second quarter of the year.
The U.S. Food and Drug Administration had rejected Northera last March and asked Chelsea to conduct another clinical trial to show the drug was effective over a longer period.
FDA's guidance was in response to a formal appeal by Chelsea to the Director of the Office of New Drugs of the FDA, Chelsea said in a statement.
In August, Chelsea changed the main goal of its earlier study, codenamed 306B, and re-reported results in December showing Northera significantly reduced dizziness in patients at week one, but results beyond that period were not statistically significant.
Chelsea said on Wednesday that the FDA guidance suggests data from its completed 306B study strongly show a short-term clinical benefit, but there was a possibility the regulator would need a post-approval study to verify the drug's long-term clinical benefit.
The company said it plans to start a new clinical trial in the fourth quarter of the year to test for long-term benefits of the drug.
Northera is aimed at treating symptomatic neurogenic orthostatic hypotension, or a chronic drop in blood pressure on standing up that is most often associated with Parkinson's disease.
Should Investor Invest Money In CHTP Or Wait: CLICK HERE
Neither HotPennyStockNews.com nor its owners, operators, affiliates or anyone disseminating information on its behalf is registered as an Investment Advisor or broker dealer in any jurisdiction whatsoever and none of the information provided by HotPennyStockNews.com, owners, operators, affiliates or anyone disseminating information on its behalf should be construed as investment advice or an investment recommendation. HotPennyStockNews.com makes no recommendation that the securities of the companies profiled should be purchased, sold or held by individuals or entities that learn of the profiled companies through HotPennyStockNews.com. Investing in securities is speculative and carries a high degree of risk and no investment should be made unless you can afford to lose your entire investment. It is possible that an investor's entire investment may be lost or impaired due to the speculative nature of the companies profiled. Please consult a broker before purchasing or selling any securities viewed on or mentioned herein..
Copyright © 2005-2013 - SBWire, The Small Business Newswire - All Rights Reserved - Important Disclaimer
Contact Us: 888-4-SBWIRE (US) - 920-321-1250 (International)