华新 - 【其它话题】瑞德西韦数据出来了

(引用笑天:火了，全文再此Gilead Announces Results From Phase 3 Trial of Investigational Antiviral Remdesivir in Patients With Severe COVID- ...)另一篇全文Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study of Investigational Antiviral Remdesivir for COVID-19 April 29, 2020 at 8:30 AM EDT PDF Version FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 29, 2020--Gilead Sciences. Inc. (Nasdaq: GILD) is aware of positive data emerging from the National Institute of Allergy and Infectious Diseases’ (NIAID) study of the investigational antiviral remdesivir for the treatment of COVID-19. We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.
Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19. Gilead will share additional remdesivir data from the company’s open-label Phase 3 SIMPLE trial in patients with severe COVID-19 disease shortly. This study will provide information on whether a shorter, 5-day duration of therapy may have similar efficacy and safety as the 10-day treatment course evaluated in the NIAID trial and other ongoing trials. Gilead expects data at the end of May from the second SIMPLE study evaluating the 5- and 10-day dosing durations of remdesivir in patients with moderate COVID-19 disease.
Gilead will continue to discuss with regulatory authorities the growing data set regarding remdesivir as a potential treatment for COVID-19.
About Remdesivir
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, Marburg, MERS and SARS. In vitro testing conducted by Gilead has demonstrated that remdesivir is active against the virus that causes COVID-19. The safety and efficacy of remdesivir for the treatment of COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
Forward-Looking Statement
This statement includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Remdesivir is an investigational drug that has not been approved by any regulatory authority, and it has not been demonstrated to be safe or effective for any use, including for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving remdesivir and the possibility that Gilead may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of remdesivir or that FDA and other regulatory authorities may not approve remdesivir, and any marketing approvals, if granted, may have significant limitations on its use. As a result, remdesivir may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s periodic reports filed with the U.S. Securities and Exchange Commission, including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

[笑天 (4-30 11:27, Long ago)] [ 传统版 | sForum ][登录后回复]41楼

(引用笑天:另一篇全文Gilead Sciences Statement on Positive Data Emerging From National Institute of Allergy and Infectious Diseases’ Study ...)23号的报告（leaked）- 科学态度？https://www.statnews.com/2020/04/23/data-on-gileads-remdesivir-released-by-accident-show-no-benefit-for-coronavirus-patients/
New data on Gilead’s remdesivir, released by accident, show no benefit for coronavirus patients. Company still sees reason for hope
By Ed Silverman @Pharmalot, Adam Feuerstein @adamfeuerstein, and Matthew Herper @matthewherper
April 23, 2020
The antiviral medicine remdesivir from Gilead Sciences failed to speed the improvement of patients with Covid-19 or prevent them from dying, according to results from a long-awaited clinical trial conducted in China. Gilead, however, said the data suggest a “potential benefit.”

A summary of the study results was inadvertently posted to the website of the World Health Organization and seen by STAT on Thursday, but then removed.

“A draft manuscript was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed. The manuscript is now undergoing peer review and we are waiting for a final version before WHO comments on it,” said WHO spokesperson Daniela Bagozzi.

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Gilead spokesperson Amy Flood said the company believes “the post included inappropriate characterization of the study.” Because the study was stopped early because it had too few patients, she said, it cannot “enable statistically meaningful conclusions.” However, she said, “trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”

The data (for details, see screenshot below) will be closely scrutinized but are also likely imperfect. The study was terminated prematurely, which could have affected the results. The context that would be provided by a full manuscript is missing, and the data have not been reviewed as normally occurs before publication.

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Related: The coronavirus pandemic could shrink some biotech startup valuations　 Many studies are being run to test remdesivir, and this one will not be the final word. Results are expected soon from a Gilead-run study in severe Covid-19 patients, although that study may be difficult to interpret because the drug is not compared to patients receiving only standard treatment. Encouraging data from patients in that study at the University of Chicago were described by researchers at a virtual town hall and obtained by STAT last week. However, unlike those data, these new results are from a randomized controlled trial, the medical gold standard.

Gilead is also running a study with a control group in more moderate Covid-19 patients, and the National Institute of Allergy and Infectious Diseases is running a study that compares remdesivir to placebo. There are even more studies of the drug ongoing.

According to the summary of the China study, remdesivir was “not associated with a difference in time to clinical improvement” compared to a standard of care control. After one month, it appeared 13.9% of the remdesivir patients had died compared to 12.8% of patients in the control arm. The difference was not statistically significant.

“In this study of hospitalized adult patients with severe COVID-19 that was terminated prematurely, remdesivir was not associated with clinical or virological benefits,” the summary states. The study was terminated prematurely because it was difficult to enroll patients in China, where the number of Covid-19 cases was decreasing.

An outside researcher said that the results mean that any benefit from remdesivir is likely to be small.

“If there is no benefit to remdesivir in a study this size, this suggests that the overall benefit of remdesivir in this population with advanced infection is likely to be small in the larger Gilead trial,” said Andrew Hill, senior visiting research fellow at Liverpool University.

He added that the results of the study should be pooled with larger studies being conducted by Gilead using a technique called meta-analysis to allow for “a balanced view of the efficacy of remdesivir from all randomized trials.”

[笑天 (4-30 11:33, Long ago)] [ 传统版 | sForum ][登录后回复]42楼

各个高人都是牛人说的头头是道，也不知道有没有道理。
作为投资者，我只相信资本市场。你们慢慢聊，我买我的股票就对了。[rjm (4-30 11:35, Long ago)] [ 传统版 | sForum ][登录后回复]43楼

(引用 Calicocat:前面中国也说了，效果肯定是有的，但不是特效，初期有效。跟WHO 现在的说法不是挺一致的吗。说实话比我预期值要低...我一直希望中国说�...)同意你完全赞同，还是希望能出更多特效药,无论中西　[本文发送自华新iOS APP] [宝狐 (4-30 11:36, Long ago)] [ 传统版 | sForum ][登录后回复]44楼

(引用 rjm:各个高人都是牛人说的头头是道，也不知道有没有道理。作为投资者，我只相信资本市场。你们慢慢聊，我买我的股票就对了。)股票和科学态度是两回事股票更接近于政治 - 呵呵呵

钱要赚，科学态度也要严谨 - 哈哈哈哈[笑天 (4-30 11:42, Long ago)] [ 传统版 | sForum ][登录后回复]45楼

(引用 douknnowme:只能说五天non inferior 或者10天 non superior)这也是正面的表述，领导都喜欢这样的而实际结果就是 5天比10天更好
准确的表达就是 -这个药用5天就好了，不需要用10天，如果用5天还治不好，就安天命吧
是不是这样？
科学道理和依据呢？
从什么时候开始给药，然后算5天，确诊？或者有明确症状? 比如SPO2<90(95%)....
都没有提到
这个只是新闻稿，不是研究报告，继续等！[笑天 (4-30 11:50, Long ago)] [ 传统版 | sForum ][登录后回复]46楼

Gilead成功了 -原来真的是政治完全是为了平衡这篇文章-人家发在柳叶刀《the Lancet》
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext[笑天 (4-30 12:17, Long ago)] [ 传统版 | sForum ][登录后回复]47楼

(引用笑天:Gilead成功了 -原来真的是政治完全是为了平衡这篇文章-人家发在柳叶刀《the Lancet》 https://www.thelancet.com/journals/lancet/articl...)PDF 这里https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931022-9[笑天 (4-30 12:19, Long ago)] [ 传统版 | sForum ][登录后回复]48楼

(引用笑天:PDF 这里https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2931022-9)不管结果如何报告应该像这样才对[笑天 (4-30 12:21, Long ago)] [ 传统版 | sForum ][登录后回复]49楼

(引用笑天:不管结果如何报告应该像这样才对)主要结果

[笑天 (4-30 12:24, Long ago)] [ 传统版 | sForum ][登录后回复]50楼

(引用笑天:主要结果 ...)OXFORD的说法http://www.ox.ac.uk/news/2020-04-29-results-remdesivir-trial-released/

This research was funded by the Wellcome Trust, the UK Department for International Development, and the Bill & Melinda Gates Foundation.[笑天 (4-30 12:27, Long ago)] [ 传统版 | sForum ][登录后回复]51楼

(引用 rjm:各个高人都是牛人说的头头是道，也不知道有没有道理。作为投资者，我只相信资本市场。你们慢慢聊，我买我的股票就对了。)原来你在聊股票....标题说清楚啊。　[本文发送自华新iOS APP] [Calicocat (4-30 13:10, Long ago)] [ 传统版 | sForum ][登录后回复]52楼

(引用 rjm:不带中医玩，神药说你无效就无效就怕以后有需要的时候，又厚着脸皮中西医结合了)张嘴就来要点脸吧[zamulano (4-30 13:12, Long ago)] [ 传统版 | sForum ][登录后回复]53楼

(引用笑天:自己和自己比，5天和10天比按我的理解，只能（要）用5天， 10天反而更差，对不对呢？ ...)副作用看起来也是有的10天用药副作用导致停药的，比5天多不少。　[本文发送自华新iOS APP] [Calicocat (4-30 13:25, Long ago)] [ 传统版 | sForum ][登录后回复]54楼

(引用 Calicocat:副作用看起来也是有的10天用药副作用导致停药的，比5天多不少。)我刚才搜了一下，才明白这个骚操作纯粹是为了抵消柳叶刀29号（同一天）的双盲试验结果的报告
从结果看，操作成功，不得不服
至于效果到底如何，那不重要，可以慢慢来
当初反应停，不是也走了一大段弯路？[笑天 (4-30 13:44, Long ago)] [ 传统版 | sForum ][登录后回复]55楼

(引用笑天:我刚才搜了一下，才明白这个骚操作纯粹是为了抵消柳叶刀29号（同一天）的双盲试验结果的报告从结果看，操作成功，不得不服至于效果到�...)虽然我早已不需要做学问了但骨子里还是做学问的人- 把一切当学问，包括股票，外汇
呵呵呵[笑天 (4-30 13:47, Long ago)] [ 传统版 | sForum ][登录后回复]56楼

歪个楼有感而发20 30年前吧，海湾战争后，中国真正意识到了跟蓝星最强鹰酱家的差距，如同永不可逾越的鸿沟。
从那之后，论坛上充斥的都是特种战法；特种兵，特种作战，导弹突袭。因为我们知道差距实在太大，只能寄希望这种一击毙命。我们沉迷武林秘籍杀手锏，妄想突击练了葵花宝典，就可以东方不败。
但幸好我们明白了修炼内功的重要性。
扛疫，是个系统工程，需要全社会统筹协调。疫苗只是其中一环。但现在美帝大统领还有部分国人，却把这个想成了武林秘籍，一招制胜。真有种河东河西之感。
果然美帝的超级英雄电影害死人啊。[Tridenttt (4-30 14:23, Long ago)] [ 传统版 | sForum ][登录后回复]57楼

(引用 Tridenttt:歪个楼有感而发20 30年前吧，海湾战争后，中国真正意识到了跟蓝星最强鹰酱家的差距，如同永不可逾越的鸿沟。从那之后，论坛上充斥的都�...)这个，去看这个http://bbs.huasing.net/sForum/bbs.php?B=107_14689699[笑天 (4-30 14:56, Long ago)] [ 传统版 | sForum ][登录后回复]58楼

可以看作两次实验一负一正，目前没看到好用还是不好用，但是副作用大倒是真的。　[本文发送自华新手机Wap版] [kusubudo (4-30 15:14, Long ago)] [ 传统版 | sForum ][登录后回复]59楼

(引用乌贼的马甲:我也没强逼着让你信不是？新闻出来了大家都有自己解读，信不信都是自己的事儿。有人信了买了股票赚一笔，有人不信在那酸葡萄酸莲花清， ...)呵呵列不列是一回事列出来的数据可信不可信是另一回事楼主这么懒容易衰老啊 [功夫熊猫 (4-30 15:36, Long ago)] [ 传统版 | sForum ][登录后回复]60楼