Donald's Email Response Thanks for your notes – needless to say, it has been a very busy week.
I cannot dispute the historical rates, nor can I give you our assessment of our chances. We do believe that we have good arguments to bring to the FDA to consider approval, notwithstanding the AdComm vote, including their own analysis in the FDA briefing document. I can say that we were very happy that all but one of the urologists voted yes and that we will be working very hard to achieve a positive outcome.
Note that the FDA can approve us for the requested indication, approve us for a narrower indication, approve us with either of these labels but require us to do another clinical trial while we sell and market, or tell us that we need another clinical trial (the worst case).
In addition, do keep in mind that we have a strong balance sheet and a strong partner in Ipsen who has rights to MCNA exUSA and Japan.
Best regards,
Don