The Complaint alleges that during the class period, Defendants represented the safety and efficacy data from the ZENITH20 trial were positive and that they had initiated a required confirmatory phase 3 study. The Complaint further alleges that starting on September 20, 2022, before the market opened, investors began to learn the truth when the FDA Oncologic Drugs Advisory Committee released a briefing document in anticipation of its September 22, 2022 meeting with Defendants to review poziotinib. Investors were surprised when, despite the Company’s repeated representations during the Class Period that the data for ZENITH20 were positive, the ODAC briefing document disclosed not only negative data on the safety and efficacy of pozi, but also a failure by the Company to enroll any patients in a required phase 3 confirmatory trial. As a result of this news, shares of Spectrum common stock declined from a closing price of $1.06 per share on September 19, 2022, to a close at $0.66 per share on September 20, 2022, a decline of $0.40 per share, or over 37% on heavier than usual volume.