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| Alias Born | 03/03/2011 |
Sunday, April 03, 2011 5:35:14 PM
1. FDA's latest CP released end of March 2011, says it is premature to talk about any criteria for determining sameness for COPAXONE
2. Company has said in it's March 2011 CC, that there is much bigger backlog compared to backlog that used to persist back when ANDA for lovenox was being reviewed. It took many many(I guess 5-6 years) to get generic LOVENOX approved after ANDA filing.
Copaxone ANDA was filed in late 2007, so any guesses would be after >5 years considering bigger backlog and also considering more complexity for determining sameness
3. Finally incentive plan, the March 2015 date
I guess how did you come up with these probabilities?
CUMULATIVE
PROBABILITY THAT
FDA APPROVES MNTA’s
COPAXONE ANDA BY
END OF GIVEN YEAR
New Old
Numbers Numbers
2011 52% 42%
2012 74% 68%
2013 81% 78%
2014 85%
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