News Focus
News Focus
Followers 5
Posts 973
Boards Moderated 0
Alias Born 03/03/2011

Re: DFRAI post# 3958

Monday, 06/20/2011 11:19:44 PM

Monday, June 20, 2011 11:19:44 PM

Post# of 20689
DFRAI - re: copaxone launch

"I expect approval very very soon."



Did you hear CW say the word 'WAIT' 5 times almost in a resonating fashion in the GS call ? That is in sharp contrast to his call sometime in Q1 as 10nis rightly pointed out.
I still think we are at least 5 months away, even in an optimistic scenario. My favorite example is Fondaparinux ANDA which Dr. Reddy's keeps saying that everything with the FDA review has gone 100% smooth...and given that they are still waiting for a final FDA action does not give me ton of confidence on an imminent copaxone approval. I agree with 10nisman, MNTA will not launch anway at risk..and patent trial most likely may last at least until November?
keep in mind fondaparinux ANDA
has GIVE "priority review" widely believed to halve the ANDA approval time and the ANDA was accepted in March 2009 . Copaxone ANDA was accepted in 2008.