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SPPI.US
id: 490, Created by Stan Vick, Scout
Enrique Osorio-Franco, et al. v. Spectrum Pharmaceuticals Case
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S.D. New York
CourtOn September 22, 2022, the FDA Oncologic Drugs Advisory Committee(ODAC) voted 9-4 not to recommend Spectrum's (SPII) poziotinib for Accelerated Approval.
- On September 23, 2022, H.C. Wainwright released a report titled “ODAC Votes Against Poziotinib; Debt Deal Announced; Lower PT by $3”. The report noted that the 9 “no” voters from the ODAC cited “non-meaningful benefit over existing therapies and cited dosing issues… Issues related to the Phase 3 confirmatory trial for poziotinib were also raised… as that study has not yet started.”
- Going back through 2021 -2022, the Company and its Leaders represented the safety and efficacy data from the ZENITH20 trial were positive and that they had initiated the required confirmatory phase 3 study.
Taking all representations into account, Investors have reasons to suspect that they were misled by the Company and its management on the prospects of its drug candidate.
Alleged Offence
Misleading Statements,
Failure to Disclose,
Negligence,
Omissions
Suspected Party
Directors,
Management,
Government Authority,
Service Provider
Security Type
Stocks
Trade Direction
Long
Shock Event Date
22 September 2022
Filing date
05 December 2022
Judge
Hon. Valerie E. Caproni