Posted by KaraS on June 16, 2005, at 17:01:52
In reply to Re: uhhhhhhh... » iforgotmypassword, posted by jrbecker on June 16, 2005, at 10:06:17
> > is this actually progress or just more red tape?
>
> bottomline, the PDUFA goal date means that the FDA has to make its decision regarding approval by Nov 27th. So, yes, in a way this is progress since the drug has been in limbo with the FDA for over 3 years now.
I didn't realize it was still a matter of "if" it is approved. I thought the issue was "when" it would be on the market.
poster:KaraS
thread:513663
URL: http://www.dr-bob.org/babble/20050611/msgs/513843.html