After jumping up big for a couple of days due to the news of the company had came to an agreement with the FDA under a Special Protocol Assessment (SPA) for both of its pivotal Phase 3 trials for oral Simufilam in treating Alzheimer's disease, Cassava Science Inc. (SAVA) dropped big today on claims of data manipulation on it test of Alzheimer drug testing. Cassava responses by the accusations are false and misleading. No matter who says what, FDA is now forced to looking into the matter and it takes time. No body knows whether the news would good or bad when dust settles. Problem is SAVA are up year to date, per quarter and per year by 1086%, 59% and 2041% respectively even after today's 31% drop.The FDA's conclusion on this matter better good or else big problem with SAVA price. I prefer to stay on the sideline and watch on SAVA. Besides, SAVA price chart looks horrible. The followings are reports and comments from various parties for your reference:
。A letter from a lawyer named Jordan Thomas of Labaton Sucharow was posted on a government website urging Billy Dunn, the director of FDA's center for drug evaluation and research to pause simufilam clinical trial. “Given the many obvious problems with the underlying research, to protect vulnerable Alzheimer's patients, the current clinical trial should be paused while a rigorous audit of Cassava's research is conducted," the letter dated August 18 read. In response to allegations, Cassava Sciences (SAVA) said the claims mentioned in the post “are false and misleading.” ---Seekingalpha.com
。Cassava is working on an Alzheimer's treatment called simufilam which binds to and stabilizes an altered version of the protein filamin A. But a "whistleblower submission" from Labaton Sucharow calls into question three major areas of concern and six smaller concerns surrounding the company's data. The firm claims Cassava engaged in "data manipulation and misrepresentation." The company responded to the Labaton Sucharow's claims saying it "stands behind its science, its scientists and its scientific collaborators." On the stock market today, SAVA stock plunged 31.4% to 80.86. ---Investors Business Daily
。For Mayank Mamtani, an analyst with B. Riley Securities, investors should buy Cassava shares on weakness following the petition. "To our knowledge, citizen petitions are commonly associated with public endorsement (or lack thereof) of drug effects from experts and medical associations, rather than from law firms representing anonymous clients without disclosing conflict of interest," he wrote. ---Bloomberg
。As a pre-commercial company without any revenue yet, all eyes are on its Alzheimer's disease candidate called simufilam. Since this is the company's only new drug candidate in clinical trials, news of any potential problem can lead to swift and heavy losses. The most troubling allegations concern heavy reliance on a single academic laboratory run by Dr. Hoau Yan Wang at the City University of New York. According to the allegations, Wang's laboratory is the only source outside of the company to confirm the foundational science supporting Cassava's claims. This includes a phase 2 biomarker study that failed miserably when patient samples were run by a lab that wasn't Wang's. The same samples ended up producing compelling data once measured again by an unnamed academic laboratory assumed to be Wang's. Cassava Sciences' contribution to neuroscience before simufilam is limited to an abuse-deterrent version of oxycodone called Remoxy that the FDA refused to approve in 2018. It's hard to imagine a company that couldn't get a new version of an old pain drug past the FDA cracking the Alzheimer's code on its first real attempt at neuroscience. It's probably a good idea to watch this biotech's story play out from the sidelines.---Fool.com
两天前因为公司用于口服 Simufilam 治疗阿尔茨海默病的关键第 3 期试验与 FDA在特别协议评估 (SPA) 上达成协议，Cassava Science Inc. (SAVA) 股票因而大升了两天后，今天却因为有人投诉Cassava在阿尔茨海默病药物测试进行了数据操纵而大幅下跌。Cassava对指控的回应是虚假和误导性的。 不管谁说什么，FDA现在会被迫调查此事，这需要时间。 当尘埃落定时，没有人知道出来的消息是好是坏。问题是 即使在今天下降了 31% 之后，SAVA 年初至今、一季度和一年分别增长了 1086%、59% 和 2041%。 FDA 对这个问题的结论一定要好否则SAVA 股价将大有问题。 我更喜欢留在场边看事态的发展而不去碰 SAVA。何况它的价位图表看来很恐怖。下面是来自各方的报道与评论供大家参考：
。来自 Labaton Sucharow 的律师 Jordan Thomas 的一封信被张贴在政府网站上，敦促 FDA 药物评估和研究中心主任 Billy Dunn 暂停 simufilam 临床试验。 “鉴于基础研究存在许多明显问题，为了保护脆弱的阿尔茨海默氏症患者，目前的临床试验应该暂停，同时对木薯的研究进行严格审核，”日期为 8 月 18 日的信中写道。针对指控，Cassava Sciences (SAVA) 表示帖子中提到的说法“是虚假和误导性的”。---SeekingAlpha.com
。Cassava 正在研究一种名为 simufilam 的阿尔茨海默氏症治疗方法，它结合并稳定了蛋白质细丝蛋白 A 的改变版本。但是来自 Labaton Sucharow 的“举报人提交”质疑了围绕该公司数据的三个主要关注领域和六个较小的问题。 该公司声称 Cassava 从事“数据操纵和虚假陈述”。 该公司回应了 Labaton Sucharow 的说法，称其“支持其科学、科学家和科学合作者”。 在今天的股市上，SAVA 股价暴跌 31.4% 至 80.86。---Investors Business Daily 投资者日报
。作为一家还没有任何收入的预商业公司，所有人的目光都集中在其名为 simufilam 的阿尔茨海默病候选药物上。 由于这是该公司在临床试验中唯一的新药候选者，任何潜在问题的消息都可能导致迅速而严重的损失。 最令人不安的指控是严重依赖由纽约城市大学的 Hoau Yan Wang 博士经营的单一学术实验室。 根据指控，王博士 的实验室是公司以外唯一确认支持 Cassava 主张的基础科学的来源。 这包括一项 第2 期生物标志物研究，该研究在患者样本由非王博士的实验室运行时则惨遭失败。 同样的样本最终产生了令人信服的数据，但是由一个相信是王博士的未命名学术实验室再次测量。在 simufilam 之前，Cassava Sciences 对神经科学的贡献仅限于一种名为 Remoxy 的抗滥用羟考酮版本，FDA 在 2018 年拒绝批准该版本。很难想象一家无法获得新版本的旧止痛药的公司能够在其首次真正的神经科学尝试中破解了阿尔茨海默氏症的密码而能通过FDA。 在场边观看这个生物技术的故事可能是个好主意。--- Fool.com
。对于 B. Riley Securities 的分析师 Mayank Mamtani 来说，投资者应该在请愿书后因疲软而购买SAVA股票。 “据我们所知，公民请愿通常与专家和医学协会对药物作用的公开认可（或缺乏认可）有关，而不是来自代表匿名客户但未披露利益冲突的律师事务所，”他写道。 ---Bloomberg 彭博社
No comments:
Post a Comment