When will the FDA approve NVS/MNTA’s Copaxone ANDA?
…many MNTA followers seem to think Copaxone has a high probability 75%+ of receiving FDA approval. Are you in the camp that thinks the chances are that high?
Since ANDA’s do not have formal timelines, a stated probability of FDA approval needs to specified with a time period to be a meaningful yardstick. These are my wild guesses:
Cumulative Probability of FDA Approval of Copaxone by Specified Date 30-Jun-2011 12% 31-Dec-2011 26% 31-Dec-2012 48% 31-Dec-2013 65% 31-Dec-2014 76% 31-Dec-2015 82%