The Shareholders Foundation announced that an investor, who purchased NASDAQ:CLVS shares, filed a lawsuit over alleged violations of the Securities Act of 1933 by Clovis Oncology.
Investors who purchased shares of Clovis Oncology Inc (NASDAQ:CLVS) have certain options and should contact the Shareholders Foundation at email@example.com or call +1(858) 779 – 1554.
The plaintiff alleges that certain Clovis Oncology Inc officials made false, incomplete, and misleading statements concerning test data which purportedly showed the efficacy and safety of Clovis Oncology Inc’s lung cancer drug – rociletinib.
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 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 NASDAQ:CLVS shares have certain options and should contact the Shareholders Foundation.
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