Thanks for the update. I was not familiar with 514 being pushed that far out. I am a bit confused on the stability data for 514 though. On the RTF conference call a year ago he clearly stated that they actually had more data on 514 than 530 as it moved to the new manufacturing facility earlier than did 530. Even if that was not the case and he just then had started collecting data, they would have 12 months next week.
Don't get me wrong, it is definitely a good idea to see how 530 fairs the process and then adjust the bigger money maker, 514, accordingly in order to get the highest probability of success. I am just not entirely sure where your timeline comes from. They have a meeting request with the FDA to discuss the 514 NDA (prior to submission). This meeting should occur (to my understanding) sometime before Feb 15, 2011 (based on the 60 day windows from the Dec 15th request). If at that time it is determined that the FDA is comfortable with the data, it takes ANX about 4-6 months to put together an NDA. Given the 60 day windows to accept/refuse that puts the 514 NDA decision about 3 quarters out, with approval/rejection of the drug itself early to mid 2012. Granted, the difference in my estimate and yours is not relevant to any day or swing traders, only long term investors.
If your statement below about not filing an NDA for 2 years is accurate, you would be looking more at a 2014 accept/reject of the drug itself (60+3 days to accept NDA, 10 Months+3 Days after that for approval) plus anything that they have to go back and re-do or any additional panels.
