SAN DIEGO, Dec. 07, 2015 (GLOBE NEWSWIRE) -- The Shareholders Foundation, Inc. announces that a lawsuit was filed in Colorado on behalf of certain purchasers of shares of Clovis Oncology Inc (NASDAQ:CLVS) over alleged Securities Laws Violations by Clovis Oncology.
Investors who purchased shares of Clovis Oncology Inc (NASDAQ:CLVS) have certain options and for certain investors are short and strict deadlines running. Deadline: January 19, 2016. (NASDAQ:CLVS) investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
The plaintiff claims that the defendants made certain false and/or misleading statements and/or failed to disclose that the New Drug Application (“NDA”) that Clovis submitted to the U.S. Food and Drug Administration (“FDA”) for rociletinib contained immature data sets based on both unconfirmed response rates and confirmed response rates, that Clovis Oncology’s Breakthrough Therapy designation submission contained immature data set based primarily on unconfirmed responses, that Clovis Oncology presented interim data publicly and at medical meetings that included a data set based primarily on unconfirmed responses, that as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected, that, as a result of the foregoing, Clovis Oncology’s NDA was likely to be delayed and/or rejected by the FDA, and that, as a result of the foregoing, the Defendants’ statements about Clovis Oncology’s business, operations, and prospects, were false and misleading and/or lacked a reasonable basis.
On November 16, 2015, Clovis Oncology Inc announced that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the FDS the agency requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib. Clovis Oncology Inc said that in the Mid-Cycle Communication meeting, the FDA emphasized that its efficacy analysis would focus solely on confirmed responses and that the New Drug Application (NDA) submitted by Clovis to the FDA contained immature data sets based on both unconfirmed response rates and confirmed response rates. Shares of Clovis Oncology Inc (NASDAQ:CLVS) declined to as low as $24.50 per share on November 23, 2015.
Those who purchased Clovis Oncology Inc (NASDAQ:CLVS) shares have certain options and should contact the Shareholders Foundation, Inc. by e-mail at mail@shareholdersfoundation.com or call +1 (858) 779-1554.
The Shareholders Foundation, Inc. is a professional portfolio legal monitoring and a settlement claim filing service, which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. The Shareholders Foundation, Inc. is not a law firm. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.