Posted by ravenstorm on April 11, 2006, at 10:47:13
In reply to Re: agomelatine (Valdoxan) - Application to FDA? » SLS, posted by jrbecker on April 5, 2005, at 21:46:19
OK, confusion continues then, because that is not what I got out of JRBEckers post:
"However, what was really the case is that Servier (the pharm company) has submitted the drug for "centralised registration," and not approval yet.
http://www.servier.com/groupe/fruits.asp
Centralised registration is the closest equivalent to the FDA's "Investigational New Drug (IND)" process, which usually takes place sometime during mid-phase clinical trials.
To clarify, it is still in phase III -- "
To me, that sounds like they are still in phase III trials in Europe, because I know from contacting the company many months ago, that they were not doing trials in the U.S. yet and didn't know when or if they would be.
I had thought they had already completed trials and submitted for approval in Europe, but that is not how I am reading JRB's latest post.
I think I will have to concur with you when I say: I am still confused!!
Poor JRB. Trying to make complicated information readily available to the depressed mind can't be easy. I really thank you for your updates on new drugs!
poster:ravenstorm
thread:479920
URL: http://www.dr-bob.org/babble/20060408/msgs/631735.html