Biotech Values

[DewDiligence]

Handicapping the Copaxone ANDA

Any additional thoughts on updating your probabilities?

Based on the plausible rumor of a Copaxone bioequivalence study
(#msg-60741332), I think the probability that the FDA will approve
MNTA’s Copaxone ANDA in 2011 has increased modestly, and the
cumulative probably the FDA will approve the ANDA in subsequent
years has increased to a somewhat lesser extent. Below are my current
probabilities compared to those I posted in Jan 2010. Feedback welcome.

 
            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%       84% 

JMHO, FWIW