The FDA will continue it's priority review of the NDA with the PDUFA date of August 3, 2010.
"The review process in Europe is also underway and expected to be completed by the end of February 2011," stated Dr. Robert Foster, President and CEO of Isotechnika Pharma.
This meeting has been canceled to allow time for the resolution of several outstanding issues. The agency intends to continue evaluating NDA 22340 and, as needed, may schedule an advisory committee meeting in the future."
Sure I'm pissed off to ..I mean, what they are clue less days before the date???????unreal...but considering they must have their sh.. together ( assumption) it isn't necessary bad,..i know myself if i want to make sure something work without blowing up when you turn the switch on..you double check everything to the last minute and make adjustment before you do even if it makes you look like your not on the ball.You don't want to f... it up,so your being extra prudent.IT COULD BE SEEN AS A GOOD THING TO I meant sure they are professional but have other things on their plate to.
To me it clearly says(The FDA will continue it's priority review of the NDA with the PDUFA date of August 3, 2010)+(The agency intends to continue evaluating NDA 22340 and, as needed)
This is where the word PRESSURE takes a real meaning. I personally thing the market over reacted.AND QUIET HONESTLY QUIT NORMAL FOR MOST OF THE INVESTOR PANIC LEVEL.I really understand why one would sell at this point.
Well anyway I will say that so you don't have to tell me...MAYBE I'M JUST A FOOL
PLease can someone tell me what is the PDUFA stand for ????