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Christopher K. Ewing, et al. v. Veru Inc. Case
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On November 9, 2022, the FDA Pulmonary-Allergy Drugs Advisory Committee voted against granting Veru’s EUA request for sabizabulin. One Committee member explained that there was “no direct evidence to support sabizabulin’s antiviral activity.”
On this news, VERU's stock price dropped over 53%, wiping out over $640 million in market capitalization.
Going back on August 11, 2022, Veru filed its Quarterly Report with the SEC, which stated that during the May 10, 2022, pre-EUA meeting, the FDA had “agreed that no additional efficacy studies were required to support a EUA application or a new drug application (NDA)” for sabizabulin, that “no additional safety data was required,” and that “the FDA agreed that the request for the EUA is supported by efficacy and safety data from our positive Phase 3 COVID-19 study . . . and no additional clinical trials are required to support an NDA submission.”
Taking all public representation into account, Veru's investors have grounds to suspect that one or more involved parties grossly breached their fiduciary duties to the Company's shareholders.
Failure to Disclose,
Shock Event Date
09 November 2022
05 December 2022
Hon. Joan A. Lenard