As reported in the WallStreet Scope
An investor, who purchased shares of Alcobra Ltd (NASDAQ:ADHD), filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Alcobra Ltd in connection with certain allegedly false and misleading statements made between March 28, 2014 and November 14, 2014.Related news item (more info at the link) Alcobra ADHD Drug Fails Key Study Except When Patients Removed From Analysis
Investors who purchased a significant amount of shares of Alcobra Ltd (NASDAQ:ADHD) between March 28, 2014 and November 14, 2014, have certain options and for certain investors are short and strict deadlines running. Deadline: January 19, 2014. NASDAQ:ADHD investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 – 1554.
According to the complaint the plaintiff alleges on behalf of purchasers of Alcobra Ltd (NASDAQ:ADHD) common shares between March 28, 2014 and November 14, 2014, that the defendants violated Federal Securities Laws.
More specifically, the plaintiff claims that defendants allegedly misrepresented and/or failed to disclose between March 28, 2014 and November 14, 2014 that its drug candidate Metadoxine Extended Release (“MDX”) did not show a statistical benefit over placebo until patients were removed from the Company’s analysis of the Phase III study, that Alcobra Ltd was presenting it analyses inconsistently, including post hoc analysis outside the original protocols, and that as a result of the foregoing, defendants’ statements about Alcobra’s business, operations and prospects, including statements about the clinical success of MDX, were false and misleading and or lacked a reasonable basis.
On October 6, 2014, Alcobra Ltd announced topline results from its Phase III study of MDX in Adult Attention Deficit Hyperactivity Disorder (“ADHD”), and declared that MDX demonstrated a statistically significant improvement in ADHD symptoms. Alcobra Ltd further stated that after removing four patients with extreme placebo responses did MDX demonstrate statistical significance in improving patient symptoms.
The same day an analyst report was published entitled, “Alcobra ADHD Drug Fails Key Study except When Patients Removed From Analysis”.
Then on October 23, 2014, Alcobra Ltd announced the presentation of new data from a Phase III study of MDX in adults with ADHD at the 61st annual meeting of the American Academy of Child and Adolescent Psychiatry. Alcobra Ltd also said that “while a complete ITT analysis by ADHD subtypes is still ongoing and was not presented at AACAP, the magnitude of symptom improvement appears to be similar in all subtypes, and the Predominantly-Inattentive ADHD (PI-ADHD) subtype alone did not produce a statistically significant outcome.”
Then, on November 17, 2014, Alcobra Ltd announced that it plans to meet with the FDA and launch a second adult Phase III study in 2015. According to Alcobra Ltd, it is “currently evaluating changes to the design and monitoring of the second trial to control the unusually high placebo response and wide response variability observed in the first Phase III study.” Shares of Alcobra Ltd (NASDAQ:ADHD) declined from $20.37 per share in late September 2014 to as low as $3.12 per share on November 18, 2014.
On January 5, 2015, NASDAQ:ADHD shares closed at $3.95 per share.
Those who purchased shares of Alcobra Ltd have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North – Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
Treatment with an experimental formulation of vitamin B6 known as MDX failed to improve the symptoms of attention-deficit hyperactivity disorder compared to placebo, according to phase III study results announced by the developer of the drug, Alcobra (ADHD) , in a statement issued Monday.
However, when Alcobra removed four placebo patients from the analysis because of "extreme" responses, the MDX benefit in the adult ADHD was positive and statistically significant, the company said.
Investors weren't buying the spin. Alcobra shares are down 47% to $7.47 in Monday trading. What's wrong with just excluding some patients and claiming victory? Think about it this way: If baseball statisticians ignored all of Derek Jeter's outs, he batted 1.000 during his major league career.
Alcobra is doing the same thing with the MDX study analysis and it doesn't smell right, either.
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