AI
Monday, August 18, 2008 7:37:04 PM
The PDUFA date is actually 2/28/09 not 2/09/09.
Maybe I misunderstood you, you might have just been referring to February '09?
"The FDA acceptance of the NDA submission indicates that the application is sufficiently complete to permit a substantive review and meets the threshold for filing. With a standard review, under the FDA Prescription Drug User Fee Act (PDUFA), the target action date is 10 months from the submission date, or February 28, 2009."
"You don't want to sell me death sticks, you want to go home and rethink your life." Obi-Wan Kenobi
Maybe I misunderstood you, you might have just been referring to February '09?
"The FDA acceptance of the NDA submission indicates that the application is sufficiently complete to permit a substantive review and meets the threshold for filing. With a standard review, under the FDA Prescription Drug User Fee Act (PDUFA), the target action date is 10 months from the submission date, or February 28, 2009."
"You don't want to sell me death sticks, you want to go home and rethink your life." Obi-Wan Kenobi
"You don't want to sell me death sticks, you want to go home and rethink your life." Obi-Wan Kenobi
