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DewDiligence

11/24/10 2:13 AM

#109441 RE: Btek #109423

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%


JMHO, FWIW