They said when they stopped the trial in March, they were only looking at data that ended in Dec 2018. Now, after they studied data that was collected after Dec 2018, they found that the picture looks better than before.
At the highest dose, there's evidence that aducanumab somewhat slowed down the progression of the disease.
There's no guarantee the FDA will approve, but Biogen is saying that the data is good enough to try to get approval.
They said when they stopped the trial in March, they were only looking at data that ended in Dec 2018. Now, after they studied data that was collected after Dec 2018, they found that the picture looks better than before.
At the highest dose, there's evidence that aducanumab somewhat slowed down the progression of the disease.
There's no guarantee the FDA will approve, but Biogen is saying that the data is good enough to try to get approval. zicklingrad 发表于 10/22/2019 9:11:55 PM
They said when they stopped the trial in March, they were only looking at data that ended in Dec 2018. Now, after they studied data that was collected after Dec 2018, they found that the picture looks better than before.
At the highest dose, there's evidence that aducanumab somewhat slowed down the progression of the disease.
There's no guarantee the FDA will approve, but Biogen is saying that the data is good enough to try to get approval. zicklingrad 发表于 10/22/2019 9:11:55 PM
They said when they stopped the trial in March, they were only looking at data that ended in Dec 2018. Now, after they studied data that was collected after Dec 2018, they found that the picture looks better than before.
At the highest dose, there's evidence that aducanumab somewhat slowed down the progression of the disease.
There's no guarantee the FDA will approve, but Biogen is saying that the data is good enough to try to get approval. zicklingrad 发表于 10/22/2019 9:11:55 PM
今天Biogen暴涨，不是阿兹海默无法治愈吗？之前drop的药怎么又要通过FDA审批了？
仍然不懂😅
At the highest dose, there's evidence that aducanumab somewhat slowed down the progression of the disease.
There's no guarantee the FDA will approve, but Biogen is saying that the data is good enough to try to get approval.
原来如此。谢谢
很难吧。造假这个公司完了
同问。经常收到通知某股票大跌，律师要告等等。这种class action lawsuit有用吗？股市不是自负盈亏吗？
一般shareholder就算告得入大家分红一般没多少。
就多了3个月的data,结果就变成有效了，有些难以让人信服。最高的dose以前肯定也evaluate过，能让他们把trial 停下来，结果得有多不promising. ---发自Huaren 官方 iOS APP
Dose 高了副作用也大啊！痴呆病人已经这么悲催了吗？药吃不死就行了嘛？
somewhat slowed down，这用词…… ---发自Huaren 官方 iOS APP
同觉得。。。 ---发自Huaren 官方 iOS APP
不是要通过FDA审批了，是公司把数据拿出来又做了subgroup analysis，发现high dose的组有点戏，打算整理数据送FDA审批。
但是问题是，现在除了公司大家也不知道他们是怎么分组怎么分析的，更何况subgroup analysis在FDA是不可能过审的。我觉得这事很大可能还是白激动一场，当然公司死马当作活马医的心情可以理解
是啊，我记得关于老年痴呆以前这个版上讨论过，大家的结论都是基本零希望。
我对biotech没有研究。用词不准请见谅。
是啊，很奇怪。
研究了一下这次Biogen的消息， 三期是今年三月份终止的， 因为数据出来没有达到预期， 当时数据是来自18年底时的吧。 这次分析高剂量的subset 有效， 所以ＢＩＯＧＥＮ决定向FDA申请了。 重点是从三期终止到现在， 一直有FDA的involvment, 他们的frutility analysis 是在和FDA交流下进行的， 并不是关门自己搞搞就放个卫星， 所以感觉BIOGEN这次是有一定信心的。 另外BIOGEN同时在向欧洲和日本市场申请许可， 不管拿到哪一个， BIOGEN的股票还会大涨， AD领域现在一片空白， 市面上的药都只是改善症状， 对病程本身无用。
这个事情还有一个很可疑的地方，就是Biogen的药和其他几家都是针对beta淀粉样蛋白的，那几个药厂都fail了，当然也可能是那几家都没有找对路子。另外他们公司有两个差不多的实验，一套里高剂量好用低剂量不好用，另外一个是高低剂量都不好用但是高剂量的更差。
这个药FDA同意送审还有一个重要因素是unmet medical need， 阿兹海默的药基本完全没有但是病人特别多。FDA现在有加速审批的，但是近年来发现好多放宽要求加速审批的药后来大规模临床实验中证明无效，所以也是很受批评。当然希望这个药能有突破，但是目前看来还是需要谨慎观望
大脑坏死是不可逆的，大概能做的就是延缓进程。 但是老年痴呆症的进程需要跟随15年以上，基本上又可以骗一轮钱。
完全同意。 现在全球都人口老龄化， 得老年痴呆的人越来越多， 以前好几个大的clinical trial都失败， 大家都有点desperate.
有意思。
不少药。特别是抗癌药，基本20-30%有improvement，那就是benefits outweighed risks,有的在clinical trial 二期就批准了。因为要死的人哪怕是一点点希望也愿意去试。别说20-30%了。副作用和生命比起来，可以忽略。后来出的好多recall 和这些也是有原因的。没有绝对的right or wrong.