也可能我过于保守了。最乐观的估计也有可能是一年半。
目前Dexpraipexole处于3期第一次实验,明年初会出结果。今天又查了一下对Dexpraipexole的展望。以下是查到的结果:
Just got official word that the second phase 3 trial of Dexpraipexole, the ENDEAVOR trial, is not planned before 2013. Its execution will depend on success of the first phase 3, the EMPOWER trial. If the EMPOWER trial has great results, Biogen Idec will file an NDA to the FDA based on only the first trial. If the first trial does not have exceptional results, no NDA will be filed and the ENDEAVOR trial will be pursued first, with the logic being that two trials will be required to attain FDA approval.
So, if the EMPOWER trial has exceptional results, market availability could occur as soon as 1 year following the EMPOWER trial results, i.e, available as soon as early 2014. If not, the clock is probably reset in early 2013 for at least 2.5 years, including the ENDEAVOR trial.
来自官方的消息,2013年以前不会有3期二次实验,因为其是否进行取决于3期第一次实验结果。如果3期第一次实验结果非常理想,则Biogen Idec公司可以向FDA递交新药申请(New Drug Application),如果FDA批准了,则可上市,时间大概是实验结束后一年,即2014年初。但如果3期第一次实验结果一般,则要进行3期二次实验,从2013年初算起至少还要两年半的时间才有可能上市。