A class action lawsuit was filed in the United States District Court, Middle District of Tennessee against BioMimetic Therapeutics, Inc. (Nasdaq: BMTI) and certain of its officers on behalf of a class consisting of all persons or entities who purchased BMTI securities from October 14, 2009 through May 11, 2011, inclusive (the "Class Period"). The Complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. Sections 78j(b) and 78t(a), and Rule 10b-5 promulgated thereunder.
Throughout the Class Period, Defendants conditioned investors to believe that FDA approval of Augment would be forthcoming through a host of materially false and misleading statements regarding the status of Augment's ongoing clinical studies, and the safety and efficacy of the Company's product.
Specifically, Defendants made false and/or misleading statements and/or failed to disclose material facts regarding: (a) the Company's business, operations, management, future business prospects and the intrinsic value of BMTI's common stock; (b) the safety and efficacy of Augment and its prospects for FDA approval; and (c) the woeful inadequacies of Augment's clinical trials. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.
On May 10, 2011, the FDA published briefing documents on Augment that were critical of Augment's clinical trial, stating the "FDA still has clinical concerns with the safety and overall risk/benefit of the device at this time, primarily due to the unanswered question of safety in regards to the potential for cancer formation versus an unproven benefit in the current standard for care."
On this news, BMTI's stock price plummeted approximately $4.73 or over 35% and closed at $8.66 on unusually heavy volume.
On May 13, 2011, BMTI disclosed that the FDA Panel voted by a narrow margin of 10-8 in favor of Augment's efficacy, making it highly unlikely that the device will receive FDA approval without requiring additional trials, substantially delaying the launch of the product. As a result of the news regarding the narrow Panel vote, BMTI shares declined nearly 12% or $1.095 and closed at $8.105.
If you are a current shareholder or purchased shares during the period of October 14, 2009 through May 11, 2011 and would like to discuss your options of exercising your rights as a shareholder, please contact us.
Please submit the following information so we can determine if you qualify for the suit. If you don't know all the specific details, partial information is also acceptable.