Worst trade of the year, page-106

The FDA did not ask for another trial to prove efficacy. They asked for another trial to prove effectiveness. If you re-read the announcement you will see that. People investing in drug development companies should know the difference and would then appreciate that there is nothing inconsistent with the FDA's ruling. It is a black mark on management for not having this squared away before going to the FDA and makes me wonder about the possibility of accelerated approval. On the one hand the FDA has doubts about the effectiveness yet on the other doctors in the field are looking forward to it being available. The lack of side effects makes me lean towards thinking they will agree to accelerated approval, but no sure thing in my book.