Biotech Values

[DewDiligence]

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