Posted by Katgirl on November 15, 2009, at 9:16:05
In reply to Re: Epilvanserin--new sleep med » Phidippus, posted by Phillipa on November 14, 2009, at 18:58:01
Actually it has completed phase III and they thought the drug was going to launch in a few months, but the FDA wants more information in regards to "risk-benefit". They will be meeting with the FDA to see if that means they have to go back and do more trials or if they can take information from the trials they have already done. I just wondered what in the final phase III results could have raised the FDA's concern.
poster:Katgirl
thread:925731
URL: http://www.dr-bob.org/babble/20091107/msgs/925804.html