这种随口乱喷的真的很无语 你真的懂么？ A study published Sunday in the Milbank Quarterly journal found that around 80 percent of the time, Food and Drug Administration decisions regarding drugs and devices were in accordance with the recommendations from advisory committees, also known as AdComs; about 20 percent of the time they were not. The study looked at 376 AdCom meetings regarding 298 products or product classes that took place between 2008 and 2015.
这种随口乱喷的真的很无语 你真的懂么？ A study published Sunday in the Milbank Quarterly journal found that around 80 percent of the time, Food and Drug Administration decisions regarding drugs and devices were in accordance with the recommendations from advisory committees, also known as AdComs; about 20 percent of the time they were not. The study looked at 376 AdCom meetings regarding 298 products or product classes that took place between 2008 and 2015. summerline 发表于 2021-06-08 13:57
“This isn’t the first time when I was on a committee where the committee voted one way and the FDA decided another,” said biostatistician Scott Emerson, a professor emeritus at the University of Washington, who has served on many advisory committees in different disease areas. “This was the first time that nobody voted for approval of this drug — nobody — and they went against that.”
这种随口乱喷的真的很无语 你真的懂么？ A study published Sunday in the Milbank Quarterly journal found that around 80 percent of the time, Food and Drug Administration decisions regarding drugs and devices were in accordance with the recommendations from advisory committees, also known as AdComs; about 20 percent of the time they were not. The study looked at 376 AdCom meetings regarding 298 products or product classes that took place between 2008 and 2015. summerline 发表于 2021-06-08 13:57
每次都是神反转。不过市场上没有药，FDA批一个我也不惊讶。
这是很靠谱的解释，手动赞一下。
FDA的统计师是反对批准的，都是要脸的😂
用的是surrogate endpoint，有没有临床benefit不确定啊……
FDA要求的，一般三期都需要2个study，以证明这个药确实有效的确定性。
像这种一正一负的结果，一般都不会批的，会打回去需要停供更多的数据，有些公司可能就放弃了。
这种随口乱喷的真的很无语
你真的懂么？
A study published Sunday in the Milbank Quarterly journal found that around 80 percent of the time, Food and Drug Administration decisions regarding drugs and devices were in accordance with the recommendations from advisory committees, also known as AdComs; about 20 percent of the time they were not. The study looked at 376 AdCom meetings regarding 298 products or product classes that took place between 2008 and 2015.
那之前放弃了的公司现在可以要求也批准吗
https://www.statnews.com/2021/06/08/fda-expert-panel-resigns-alzheimers-approval/
是抗议吧？
批了这个比安慰剂好一点药是对 研究这个病的所有同仁打气。
确实如此，各大制药公司砸了很多钱，在这20年里面，没有一个公司的研发取得进展 这次通过了，可以激发各大制药公司再次投钱研发 从这个角度说是好事情 另外广大患者强烈要求通过，没办法，救命稻草能抓住一个就不错了
“This isn’t the first time when I was on a committee where the committee voted one way and the FDA decided another,” said biostatistician Scott Emerson, a professor emeritus at the University of Washington, who has served on many advisory committees in different disease areas. “This was the first time that nobody voted for approval of this drug — nobody — and they went against that.”
但这一次是第一次１１人ｐａｎｅｌ 没人同意（１０反对，１人不确定）的情况下ｆｄａ 批准了药
我有这个股票，就是去年吧唧下来盘整时买的，除了这个药这家还是很好的制药公司。 不是马后炮，我觉得fda总会批的，关键Alzheimer没有什么药，病人多而且一旦得上对家人亲人都是折磨。据说ad一年治疗费是53000。
对，低剂量的trial效果差 后来发现高剂量的效果还可以 这就是为啥这个药物研发结果一波三折 股价上下跳的原因
没有就是没有，人类要承认自己的局限性，不能没有就抓个安慰剂来充数
indeed
撞南墙太多次也得回头
其实应该提高预防
比如提倡睡眠质量和听力训练之类的
另外保险公司如果不报销 能吃得起都是有钱人 替有钱人担心啥
中国得这个老年痴呆的比例还高于别的国家 不知道原因
关于Alzheimer,很多都还没研究清楚，有亲人得这个，年纪大了突然就有症状了，天翻地覆的变化。
要说预防的话，还是那些，健康生活方式，多运动，健康饮食，吃鱼油抗氧化，剩下就只有基因了