San Diego, CA -- (SBWIRE) -- 05/30/2017 -- An investor in shares of Clovis Oncology Inc (NASDAQ:CLVS) filed a lawsuit against directors of Clovis Oncology Inc over alleged breaches of fiduciary duties.

If you purchased f shares of Clovis Oncology Inc (NASDAQ:CLVS), you have certain options and you should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call 858-779-1554.

The plaintiff alleges that the defendants submitted "corrupt" data to the U.S. Food and Drug Administration connected to the clinical trial for lung cancer treatment.

On May 31, 2015, at the American Society of Clinical Oncology Medical Conference, Clovis Oncology Inc claimed that it had observed an objective response rate ("ORR") of 60% for rociletinib, which represented the percentage of patients who experienced a clinically meaningful tumor shrinkage when treated with the drug.

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 19, 2015 a lawsuit was filed against Clovis Oncology over alleged securities laws violations. The plaintiff claimed 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 April 8, 2016, the U.S. Food and Drug Administration revealed that Clovis Oncology Inc had concealed that rociletinib was not well tolerated, and that serious adverse events were reported in 47% of patients treated with the drug.

Those who purchased shares of Clovis Oncology Inc (NASDAQ:CLVS) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com