San Diego, CA -- (SBWIRE) -- 11/30/2016 -- An investigation on behalf of investors in shares of Clovis Oncology Inc (NASDAQ:CLVS) concerning potential breaches of fiduciary duties by certain Clovis Oncology directors was announced.
Investors who are current long term investors in Clovis Oncology Inc (NASDAQ:CLVS) shares, have certain options and should contact the Shareholders Foundation at email@example.com or call 858-779-1554.
The investigation by a law firm for current long term investors in Clovis Oncology Inc (NASDAQ:CLVS stocks follows a lawsuit filed against NASDAQ:CLVS over alleged securities laws violations. The investigation on behalf of current long term investors in NASDAQ:CLVS stocks, concerns whether certain Clovis Oncology directors are liable in connection with the allegations made in that lawsuit.
According to that complaint filed in the U.S. District Court for the District of Colorado the plaintiff alleges that the Defendants made false and/or misleading statements and/or failed to disclose: (1) that the New Drug Application ("NDA") that Clovis submitted to the FDA for rociletinib contained immature data sets based on both unconfirmed response rates and confirmed response rates; (2) that Clovis' Breakthrough Therapy designation submission contained immature data set based primarily on unconfirmed responses; (3) that Clovis presented interim data publicly and at medical meetings that included a data set based primarily on unconfirmed responses; (4) that as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected; (5) that, as a result of the foregoing, Clovis' NDA was likely to be delayed and/or rejected by the FDA; and (6) that, as a result of the foregoing, the Defendants' statements about Clovis' business, operations, and prospects, were false and misleading and/or lacked a reasonable basis.
On November 16, 2015, Clovis Oncology Inc (NASDAQ:CLVS) announced that during its regularly scheduled Mid-Cycle Communication Meeting held last week with the U.S. Food and Drug Administration (FDA), 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.
On November 29, 2016, NASDAQ:CLVS shares closed at $35.62 per share.
Those who purchased shares of Clovis Oncology Inc have certain options and should contact the Shareholders Foundation.
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