San Diego, CA -- (SBWIRE) -- 03/13/2012 -- A deadline is coming up on April 2, 2012 in the lawsuit filed for investors of Columbia Laboratories Inc. (NASDAQ:CBRX) over certain statements made by Columbia Laboratories Inc. that at the time they were made were materially false and misleading.
Investors with a substantial investment in Columbia Laboratories Inc. (NASDAQ:CBRX) shares between December 6, 2010 and January 20, 2012, should get active before the Deadline that is coming up on April 2, 2012 and should contact the Shareholders Foundation at mail(at)shareholdersfoundation.com or call +1(858) 779 - 1554.
According to the complaint filed in the U.S. District Court, District of New Jersey the plaintiff alleges on behalf of purchasers of Columbia Laboratories Inc. (NASDAQ:CBRX) securities between December 6, 2010 and January 20, 2012, that Columbia Laboratories, Inc and certain of its officers violated the Securities Exchange Act of 1934 by issuing allegedly materially false and misleading statements.
Specficially the plaintiff alleges that Columbia Laboratories, Inc conditioned investors to believe that Columbia Laboratories’ PROCHIEVE progesterone vaginal gel 8% , a gel intended to prevent preterm births in women with short cervices, would receive Food and Drug Administration (“FDA”) approval through a host of statements regarding the safety and efficacy of the product, as well as reportedly positive results from PROCHIEVE's clinical trials.
On December 14, 2011, Columbia Laboratories Inc announced that a meta-analysis of data from five double-blind, placebo-controlled trials its progesterone gel product "significantly reduces the risk of preterm birth and neonatal morbidity."
However on January 17, 2012 a report by the Food and Drug Administration staff about Columbia Laboratories progesterone gel to reduce the risk of preterm birth was released. According to the report Columbia Laboratories’ progesterone gel wasn’t effective.
On January 20, 2012, Columbia Laboratories, Inc. (Nasdaq: CBRX), and Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed that the Advisory Committee for Reproductive Health Drugs of the U.S. Food and Drug Administration (FDA) declined to recommend the approval of progesterone vaginal gel 8% for the reduction of risk of preterm birth in women with short uterine cervical length at the mid-trimester of pregnancy. While panel members generally agreed that progesterone vaginal gel 8% is safe, the panel stated that more information is needed to support approval.
Columbia Laboratories, Inc said the final decision regarding the approval of the product rests solely with the FDA and the FDA's Division of Reproductive and Urologic Products is expected to take action on Columbia's New Drug Application (NDA) by February 26, 2012.
On the same day a media report cited advisors to U.S. regulators saying Columbia Laboratories Inc. (CBRX) and Watson Pharmaceuticals Inc. (WPI) didn’t provide sufficient data that their progesterone gel reduces the risk of preterm birth.
Columbia Laboratories Inc. (NASDAQ: CBRX) shares declined an additional $0.874 per share or more than 55%, to close at $0.706 per share on January 23, 2012. On Monday, March 12, 2012 NASDAQ: CBRX shares closed at $0.67 per share.
Those who purchased shares of Columbia Laboratories Inc. (NASDAQ: CBRX) have certain options and should contact the Shareholders Foundation.
Shareholders Foundation, Inc.
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