a******g
发帖数: 13519 | 1 3月29日，微信公众号“吉利德科学”发布吉利德科学董事长兼首席执行官Daniel O’
Day公开信，其中指出瑞德西韦从未被批准使用，但是根据我们到目前为止的了解，我
们知道它可能有潜力治疗新型冠状病毒。 | a******g
发帖数: 13519 | | Y****1
发帖数: 1 | 3 价格比板蓝根还贵
【在 a******g 的大作中提到】
: 看来，瑞德西韦真的还不如板蓝根。
| a******g
发帖数: 13519 | 4 美国制造就是这屌操性，又贵，又没卵用。
【在 Y****1 的大作中提到】
: 价格比板蓝根还贵
| a******g
发帖数: 13519 | | w***x
发帖数: 1763 | | s********i
发帖数: 17328 | | W*****B
发帖数: 1 | 8 批准使用了还做什么双盲试验？产逼真他妈的弱智。
现在是多方加速：
1 clinical trials in multiple countries, results in the coming weeks.
2 继续同情用药（目前为止批准了1000例）
3 由于同情用药手续繁杂，不能满足目前众多患者的需求，做如下改进
3a 对于孕妇和儿童，同情用药继续开放
3b 增设expand access program，这样医生可以一次为多个危重病人申请同情用药。
美国已经开始。 | W*****B
发帖数: 1 | 9 An Open Letter from our Chairman and CEO
Daniel O’Day - March 28, 2020
When the news of the coronavirus first emerged, Gilead immediately began to
investigate the potential of remdesivir, a medicine we had been studying for
many years as part of our extensive research in antivirals. Remdesivir had
never been approved for use but based on what we had learned to date, we
knew it might have potential with the novel coronavirus. Since then, we have
been working with the greatest sense of urgency and responsibility to
determine whether remdesivir does indeed work against COVID-19.
The urgency comes from knowing the desperate need among patients and the
lack of any approved treatment. The responsibility is to ensure that
remdesivir, an investigational medicine, is effective and safe before it is
distributed for use worldwide.
This is why we have been working at unprecedented speed to enroll patients
in clinical trials. Establishing the safety and efficacy of remdesivir, in
partnership with regulatory authorities, is essential to potentially
enabling the treatment of many more patients in the future. Multiple studies
are ongoing, and we are on track to have initial data in the coming weeks.
If it is approved, we will work to ensure affordability and access so that
remdesivir is available to patients with the greatest need.
In the meantime, we have made the investigational medicine available for
severely ill patients who cannot enroll in a trial. This “compassionate use
” program is typically reserved for a small number of individual cases but
there is nothing typical about this crisis and to date we have provided
remdesivir to more than 1,000 patients. The program is designed by
regulatory authorities in such a way that each application has to be
reviewed on an individual basis. This works well when there is only a
limited number of requests – as is normally the case – but the system
cannot support and process the overwhelming number of applications we have
seen with COVID-19.
To address this, we are transitioning to what should be a more streamlined,
sustainable approach with “expanded access” programs. The compassionate
use program will continue for children and pregnant women only, reducing the
numbers to a level where the system can cope. With expanded access,
hospitals or physicians can apply for emergency use of remdesivir for
multiple severely ill patients at a time. While it will take some time to
build a network of active sites, this approach will ultimately accelerate
emergency access for more people. Initial sites in the United States are up
and running as of yesterday, and it is expected that sites in additional
countries will be activated soon.
In recent days, many people have reached out to Gilead to advocate for
access to remdesivir on behalf of friends and loved ones. I can only imagine
how it must feel to be in that situation. We are used to seeing numbers and
statistics in the news on a daily basis but we all know that behind each of
those numbers is a real and often heartbreaking human story. I know I speak
for everyone at Gilead when I say how much we all wish we could help every
patient in need. Today we are working at speed to establish the temporary
expanded access programs, while at the same time establishing the potential
safety and efficacy of remdesivir and determining for which patients
remdesivir may have activity.
Remdesivir is still an investigational medicine. We are planning for the
outcome we all hope for – that it will prove to be a safe, effective
treatment – and in the meantime we are taking the ethical, responsible
approach to determining whether that is the case. At each step of the way,
our decisions are informed by guidance from public health authorities and
bioethicists, and by our decades of experience in making antiviral
treatments for diseases such as HIV and viral hepatitis.
We hope that, in partnership with many groups around the world, we can play
a part in helping patients with this disease. We know how much is at stake
and the urgent need to determine whether remdesivir will be a safe and
effective treatment.
We think about the healthcare workers who are on the front lines of fighting
this pandemic around the clock and the urgent need to equip them with a
treatment. We know that patients and their families around the world are
waiting. All of us at Gilead are doing everything we can to meet our
responsibility with remdesivir, with the greatest sense of urgency and care.
As we continue with those efforts, we will provide updates on our progress
as soon as information becomes available, recognizing the significant public
interest in remdesivir around the world. | l******t
发帖数: 55733 | 10 有特效我鳖早大规模投入使用了，别再最后踹腿了
【在 W*****B 的大作中提到】
: 批准使用了还做什么双盲试验？产逼真他妈的弱智。
: 现在是多方加速：
: 1 clinical trials in multiple countries, results in the coming weeks.
: 2 继续同情用药（目前为止批准了1000例）
: 3 由于同情用药手续繁杂，不能满足目前众多患者的需求，做如下改进
: 3a 对于孕妇和儿童，同情用药继续开放
: 3b 增设expand access program，这样医生可以一次为多个危重病人申请同情用药。
: 美国已经开始。
| | | L****8
发帖数: 3938 | 11 不如 双黄连
【在 a******g 的大作中提到】
: 3月29日，微信公众号“吉利德科学”发布吉利德科学董事长兼首席执行官Daniel O’
: Day公开信，其中指出瑞德西韦从未被批准使用，但是根据我们到目前为止的了解，我
: 们知道它可能有潜力治疗新型冠状病毒。
| d**e
发帖数: 1124 | 12 FDA批准的是同情用药，2周前
没人说这个新药已经被批准广泛使用
全球还没有一个被批准广泛使用的新冠药
只有off label使用的，有批准喹啉 | W*****B
发帖数: 1 | | W*****B
发帖数: 1 | | T*****T
发帖数: 640 | 15 +1
【在 l******t 的大作中提到】
: 有特效我鳖早大规模投入使用了，别再最后踹腿了
| w***x
发帖数: 1763 | 16 法匹拉韦在日本和中国都是被正式批准的新冠用药
【在 d**e 的大作中提到】
: FDA批准的是同情用药，2周前
: 没人说这个新药已经被批准广泛使用
: 全球还没有一个被批准广泛使用的新冠药
: 只有off label使用的，有批准喹啉
|
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