Ok, even after Chicago I am confused. So we will file in early 2015 but we only anticipate getting the 5mg approved from OPT? We need the 10mg to differentiate, but everyone was very noncommittal about that. I'll keep plugging away, but my team needs the efficacy of 10mg to make up for the AEs. Do you get that?
Europe killed the 10mg because the toxicity is dose related. The 5mg benefits didn't exceed the risks. We are lucky to have the 5mg here. Hit your A-B targets. Follow the plan. Show the signs and symptoms and sell the disease progression data. How hard is that. It doesn't matter if we make any numbers, what matters is if we hit all our activity metrics.
We will soon have to take a compliance exam on line and attend a web cast to certify that we won't sell for hair loss.
