Posted by Marty on September 2, 2008, at 10:44:21
In reply to Re: Getting back on Agomelatine (Valdoxon) » subconscious101, posted by Nadezda on September 2, 2008, at 10:23:05
Nadezda,
> But there are five clinical trials, all not recruiting, all scheduled to be completed in the 2009, one of t hem not until October. Sounds like agomelatine won't be available until at least 2010.
---I don't think the 2009 scheduled clinical trials are significative regarding the marketting date of Agomelatine. There will be many clinical trials on this drug, non stop, for many years if it were to be marketed: seeking approval for other disorders, strengthening the reputation of the drug and creating a buzz with good trial results etc. Even if the EMEA approve AGO in 2008, Servier needs to generate other good trial results to compensate for some that were not very good in order to make it clear in the mind of the practicians: there's a world of difference between "AGO -IS- working.. 8 out of 11 trials proved it" .. Versus .. "4 out of 7 trials proved it". Also those clinical trials in 2009 could be a 'Plan C' for Servier if the EMEA doesn't approve AGO in 2008... to prepare themself for a 3rd submission to the EMEA.
I still think we could se AGO marketed in Europe between this month and Febuary 2009.
BTW, Have you tried Agomelatine Nadezda ?
/\/\arty
poster:Marty
thread:849568
URL: http://www.dr-bob.org/babble/20080822/msgs/849879.html