San Diego, CA -- (SBWIRE) -- 05/14/2012 -- An investor in NASDAQ:CHTP shares filed a lawsuit against directors of Chelsea Therapeutics International Ltd. over alleged breaches of fiduciary duties over certain statements made in connection with Chelsea Therapeutics’ new drug Northera.
Investors who are current long term stockholders in shares of Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) have certain options and should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
According to the complaint the plaintiff alleged that Chelsea Therapeutics International Ltd. lied about the anticipated approval by the U.S. Food and Drug Administration of Chelsea Therapeutics’ drug Northera, known generically as Droxidopa, which is intended to help treat symptoms of Parkinson's disease.
The plaintiff claims that Chelsea Therapeutics International Ltd knew that the drug was not fit for FDA approval and unlikely to obtain FDA approval due to serious health risks after at least 19 deaths during clinical trials.
Then on February 13, 2012, Chelsea Therapeutics International Ltd announced that it had received a briefing document prepared by FDA staff that revealed results of an Advisory Committee tasked with determining the safety of Northera and the plaintiff says that "the briefing document indicated that the FDA raised questions concerning Northera's risk-benefit analysis."
On February 23, 2012, Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the FDA Cardiovascular and Renal Drugs Advisory Committee voted 7-4 with 1 abstention and 1 non-vote to recommend approval of NORTHERA.
However, then on March 28, 2012, after the market closed, Chelsea Therapeutics International disclosed that it had received a complete response letter from the FDA whereby it rejected the Company's New Drug Application for Northera. Moreover, the FDA requested that the Company "submit data from an additional positive study to support efficacy demonstrated in Study 301 along with the recommendation that such a study be designed to demonstrate durability of effect over a 2- to 3-month period."
NASDAQ:CHTP shares dropped from almost $5 on February 10, 2012 to under $2.50 in the end of March 2012 and closed on May 11, 2012 at $2.20 per share
Those who are current long term stockholders in shares of Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) have certain options and should contact the Shareholders Foundation.
Shareholders Foundation, Inc.
3111 Camino Del Rio North - Suite 423
92108 San Diego