Cassava Sciences Cooperates With DOJ, SEC On Controversial Alzheimer's Drug Investigation
Cassava Sciences Cooperates With DOJ, SEC On Controversial Alzheimer's Drug Investigation
Cassava Sciences (NASDAQ:SAVA) has engaged the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC) amid ongoing investigations into the company and two senior employees.
Cassava Sciences (納斯達克股票代碼：SAVA)已經就公司和兩名高管當前正在進行的調查與美國司法部和美國證券交易委員會進行了溝通。
Cassava's board formed an Ad Hoc Investigation Committee to oversee outside counsel conducting the investigation. The Committee also oversees the company's disclosures related to the investigation, the company said in an SEC filing.
Cassava的董事會成立了一個特別調查委員會來監督負責調查的外部律師。該委員會還監督公司與調查相關的披露，公司在SEC備案中表示。
On Friday, the DOJ announced an indictment against Dr. Hoau-Yan Wang, alleging he submitted fraudulent grant applications to the National Institutes of Health.
上週五，美國司法部宣佈起訴黃浩研究員，指控他向美國國立衛生研究院提交了欺詐性的撥款申請。
The indictment claims Dr. Wang made false statements about the mechanism of simufilam and manipulated research results, including fabricating Western Blot images.
起訴書稱，黃博士對simufilam的機制進行了虛假陳述，並操縱了研究結果，包括製作虛假的Western Blot圖像。
Dr. Wang, a professor at the City University of New York, was a former scientific collaborator and advisor to Cassava. His research, alongside Dr. Lindsay Burns, Cassava's SVP of Neuroscience, led to the discovery of simufilam.
黃博士是紐約市立大學的教授，曾是Cassava的科學合作者和顧問，與Cassava的神經科學高級副總裁Lindsay Burns博士一起發現了simufilam。
Dr. Wang's lab conducted the final bioanalysis for the Phase 2b study. He received a monthly stipend of $2,000 and stock options for his consulting work with Cassava, which were terminated before his indictment.
黃博士的實驗室爲2b期研究進行了最終的生物分析工作，並因爲與Cassava的諮詢工作而獲得每月2000美元的津貼和期權，而這些職位在他被起訴前已被終止。
Cassava's ongoing internal investigation has revealed the potential unblinding of some Phase 2b study participants due to an email sent by a senior employee.
Cassava正在進行的內部調查揭示了由一名高管發出的電子郵件可能導致一些2b期研究參與者知曉他們所接受的治療情況。
The Phase 2b study aimed to measure changes in cerebrospinal fluid (CSF) biomarkers and cognitive outcomes using the Cambridge Neuropsychological Test Automated Battery over 28 days.
2b期研究的目標是使用劍橋自動化神經心理測試電池(Cambridge Neuropsychological Test Automated Battery)來測量腦脊液生物標誌物和認知結果的變化，該測試爲期28天。
Cassava reported significant improvements in biomarkers based on Dr. Wang's bioanalysis. However, the cognition portion of the study, analyzed for effect size rather than statistical significance, excluded certain participants.
基於黃博士的生物分析結果，Cassava報告了生物標誌物的顯著改善。然而，研究的認知部分是根據效應大小而不是統計顯著性來分析的，排除了某些參與者。
Despite the controversy, Cassava is proceeding with two Phase 3 clinical trials of simufilam, both fully enrolled with about 1,900 patients. Data and samples from these trials will be analyzed by independent firms, with no involvement from Dr. Wang or his lab.
儘管存在爭議，Cassava正在進行兩項完全招募了約1900名患者的simufilam三期臨床試驗。這些試驗的數據和樣本將由獨立公司進行分析，而黃博士或他的實驗室將不參與其中。
Price Action: SAVA shares are down 7.69% at $11.40 at last check Monday.
截至上週一最後一次查看，SAVA股票下跌了7.69%，至11.40美元。
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譯文內容由第三人軟體翻譯。