ARC-520要失败的节奏啊？

rxsm

其实外国人研究的520，就是大家小时候玩过的布、剪刀、石头。

可与言者

单从II期临床上看Replicor的REP 2139联合干扰素或核苷药的疗效比ARC520强，没必要把箭头当成救世主。

丰华硕实

美国药商为了卖药赚钱,肯定会利用政府关系扼杀520.521,这是很平常的事.还是看韩春雨的基因编辑技术吧.

newchinabok

回复 丰华硕实 的帖子

据说小韩是明年诺贝尔奖大热门，乙肝小菜一碟。小韩一出手，欧美药企估计都要回家给孩子喂奶去了。哈哈

llau_lhf

箭头希望不大，害我亏了不少。

东霸天

回复 StephenW 的帖子

520 521 口头叫停了  实验还会重启吗？

StephenW

回复 东霸天 的帖子

如果FDA满意安全问题, 将会重启.

disan

9 months ago, ARWR began an MTD study in monkeys - they needed to find the maximum tolerable dose in order for the drug to be approved for commercialization - you do NOT do this unless you expect to be approved and enter Phase 3 pivotal trials. Too time consuming and expensive.

After 9 months, they saw no toxicity, and increased the dosage even more, until finally, "some" monkeys got sick and eventually died.

ARWR instantly alerted all agencies in all countries of this event, even though its still "ongoing". None of the others have responded negatively, yet, however, the FDA gets it an issues a HOLD on it because they want the scientific explaination of what caused the death, DEPSITE ARWR's clearly indicating that this was a MTP study, and that the dosage was probably 50x higher than the highest dose used in any human trials (300 mpk?).

To add further insult to injury, the FDA requests that ARWR not discuss this in details with the inveting public, so we have to rely on "leaks", hence, drexeler's providing us with tweets from someone who spoke with IR. Possibly an institutional investor from the recent private placement??

The FDA may be following the rule book here, but, this is absolutely unfair to investors and shareholders.

disan

简单点说，有认为（谣传）被FDA要求做MTD最大剂量是为3期做准备

丰华硕实

回复 newchinabok 的帖子

必须的