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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 正在与司法部、证交会合作进行备受争议的阿尔茨海默病药物调查。
Benzinga ·  07/01 11:19

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 (纳斯达克股票代码:SAVA)已经就公司和两名高管当前正在进行的调查与美国司法部和美国证券交易委员会进行了沟通。

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的董事会成立了一个特别调查委员会来监督负责调查的外部律师。该委员会还监督公司与调查相关的披露,公司在SEC备案中表示。

On Friday, the DOJ announced an indictment against Dr. Hoau-Yan Wang, alleging he submitted fraudulent grant applications to the National Institutes of Health.

上周五,美国司法部宣布起诉黄浩研究员,指控他向美国国立卫生研究院提交了欺诈性的拨款申请。

The indictment claims Dr. Wang made false statements about the mechanism of simufilam and manipulated research results, including fabricating Western Blot images.

起诉书称,黄博士对simufilam的机制进行了虚假陈述,并操纵了研究结果,包括制作虚假的Western Blot图像。

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.

黄博士是纽约市立大学的教授,曾是Cassava的科学合作者和顾问,与Cassava的神经科学高级副总裁Lindsay Burns博士一起发现了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.

黄博士的实验室为2b期研究进行了最终的生物分析工作,并因为与Cassava的咨询工作而获得每月2000美元的津贴和期权,而这些职位在他被起诉前已被终止。

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正在进行的内部调查揭示了由一名高管发出的电子邮件可能导致一些2b期研究参与者知晓他们所接受的治疗情况。

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期研究的目标是使用剑桥自动化神经心理测试电池(Cambridge Neuropsychological Test Automated Battery)来测量脑脊液生物标志物和认知结果的变化,该测试为期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.

基于黄博士的生物分析结果,Cassava报告了生物标志物的显著改善。然而,研究的认知部分是根据效应大小而不是统计显著性来分析的,排除了某些参与者。

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.

尽管存在争议,Cassava正在进行两项完全招募了约1900名患者的simufilam三期临床试验。这些试验的数据和样本将由独立公司进行分析,而黄博士或他的实验室将不参与其中。

Price Action: SAVA shares are down 7.69% at $11.40 at last check Monday.

截至上周一最后一次查看,SAVA股票下跌了7.69%,至11.40美元。

  • Alzheimer's Drug Trial Results Questioned After 'Damning' FDA Inspection Report.
  • "严厉”的FDA检查报告发布后,阿尔茨海默病药物试验结果受到质疑。
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