1. We have been working at unprecedented speed to enroll patients in clinical trials. 2. 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. 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.
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. 走”同情用药“需要的手续复杂，现在开始有expanded access的program了，是不是意味着其实access会慢慢加大？ 哪些地方现在已经有initial sites for expanded access了?
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.
现在GILEAD have processed thousands of compassionate use requests and facilitated a smooth transition to our expanded access protocol. 后面expanded protocol 通过后更多的病人可以用药。
那才有几个病例符合情况啊？等于绝大多数不给用了？
这是给最低风险人群以提高治愈率的节奏吗
没有量产，stock 有限，临床用量要保证，而且investigational drug一般不这么大规模使用。中国其实并没有同情用药的规定，不知道用药是什么标准，记得gilead就开始提供了一批吧，如果大规模用，八成是有仿制药了?
当时都给了中国，所以现在美国自己的病人反而没多少可用了？
他们还有一些成药和原料药的stockpile ，多少不知道。量产是现在最大的疑问，比药效还不确定。
不是量上不去，是药没被批准，有使用限制吧。
Supposed to be in April
不知道生产快不快。
当时我听的介绍是，一个batch生产20kg，一个人一个疗程就只要很少几克。所以一个batch够很多人用。
现在美国正在爆发期，病人那么多，每天死人那么多……
感觉现有的程序，监管和手续限制了病人使用这药
也许fda考虑到这个矛盾和现状会考虑给个特批？早一天批都能救一批人的命啊
因为美国用药很烦，每个病人都要去FDA去批。
不是生产量没有，而是实验没做完，目前不能把这个当药用。
expanded access 就像申请H1 visa，一个公司申请一次可以用一段时间。
有5天和10天两种疗程，各需0.6和1.1克。假如一个病人算1克,20公斤够两万人。
西雅图那边的医生说，现在都是用不超过5天，一是5天够了（大部分人1-2天就见明显效果）二是因为药数量有限
从来没有放弃专利，药厂凭什么要放弃专利，不漫天要价就很好了。
中国山寨把原材料买空了吧
CDC叫你们普通大众不要戴口罩的时候有告诉你是因为口罩没有了吗？！
孤儿药的规定是美国境内病人数目不超过20万。
对。我们这边华人群里的大妈很兴奋地转了这则“好”消息，大呼有效。 我咋没看到这个人的发言里有半句提到有效了！
这么两句话你还要summary？
一般开发generic也是要时间的，这个是针剂，平时generic的开发周期是三到五年。
啥时候说放弃专利了？ 现在case by case处理，谁能等的到，这病轻转重再到死亡可以只要4-10天，估计paper work都还没来得及处理呢。还人民的希望，我看人民的绝望差不多。
因为中国政府同意？
Re
something fishy
你为啥家里不买一车泰诺囤着，以备不时之需？