<<-- First, why do you think the priority-vs-standard decision will be a positive/negative harbinger? I saw IV posts referencing statistical analyses of first round approval rates for priority and standard, but there was nothing really definitive in those posts. It seems to me the criteria for priority review do not necessarily predict anything about the criteria for approval, right? Or wrong?>>
Sorry, I didn't say whether or not the priority decision would be a positive or negative harbinger. I think you misquoted me. I said "incrementally positive or incrementally negative." Big difference. I think if the FDA had some issues, they would have granted standard review status to Provenge to give them more time, instead of an RTF.
<<-- Not sure how to interpret your "larger than incremental effect on the stock price" comment. Are you saying that whatever is announced(standard or priority) we may see an unjustifiably significant fall or rise? Given how impervious the stock has been to "good" news for the past year or so, my pessimistic side thinks standard may indeed result in a fall, but priority will likely only result in more sideways drifting.>>
Not sure where you come up with the phrase "unjustifiably significant fall or rise." That's not what "larger than incremental effect on the stock price" refers to. Now that priority has been granted, I can see the stock price gradually rising as more and more people realize that CBER appears to have a larger say in the approval question than CDER/ODAC. I also think there will be some short covering before the briefing doc release/advisory panel meeting occurs.
AI
