Investigation Overview
San Diego, Feb. 14, 2012 (Shareholders Foundation) -- An new investigation on behalf of investors in shares of Cell Therapeutics, Inc. (NASDAQ:CTIC) was announced over new potential securities laws violations by certain officers and directors at Cell Therapeutics in connection with its statements in regards to its New Drug Application for Pixuvri(TM).
The new investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Cell Therapeutics, Inc. (NASDAQ:CTIC) concerning whether a series of statements regarding Cell Therapeutics business, its prospects and its operations were materially false and misleading at the time they were made. Specifically the new investigation focuses on
On January 30, 2012, Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) announced that it has withdrawn its New Drug Application ('NDA') for Pixuvri (pixantrone) for the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma ('NHL') in patients who failed two or more lines of prior therapy.
Cell Therapeutics, Inc said the NDA was withdrawn because, after communications with the FDA, Cell Therapeutics, Inc needed additional time to prepare for the review of the Pixuvri NDA by the FDA's Oncologic Drugs Advisory Committee at its February 9, 2012 meeting. Prior to withdrawing the NDA, Cell Therapeutics, Inc requested that the FDA consider rescheduling the review of the Pixuvri NDA to the Oncologic Drugs Advisory Committee meeting to be held in late March. The FDA was unable to accommodate Cell Therapeutics request to reschedule, and given the April 24, 2012 Prescription Drug User Fee Act date, the only way to have Pixuvri possibly considered at a later ODAC meeting was for CTI to withdraw and later resubmit the NDA. Cell Therapeutics said it plans to resubmit the NDA in 2012.
As a result of the withdrawal of the NDA, the FDA will no longer make a decision.
Cell Therapeutics already faced a lawsuit a filed by investors who invested in the time frame between March 25, 2008 and March 22, 2010. The plaintiff in that complaint alleges that defendants, among other things, failed to disclose that the Special Protocol Assessment (SPA) with theFDA for pixantrone was invalidated in March 2008. Recently Cell Therapeutics agreed to pay $19million to settle this lawsuit. The settlement still needs court approval and is not yet finalized.
Shares of Cell Therapeutics, Inc. (Public, NASDAQ:CTIC) fell since its 1:6 split on May 16, 2011 from slightly over $2.20 per share to slightly $1 per share.