The lack of statistical significance referenced in the breifing documents was already known
Do you think Eisai spent months of time and money preparing this application and J&J did the same in Europe and didnt know about this.
They obviously think there are some compelling arguments for approval or they wouldnt have bothered. The FDA thinks its worthy of discussion or they would have rejected it outright without an advisory panel hearing
Im not saying it getting approved but really nothing has changed since yesterday and its retail traders heading for the hills.
An approval would be great but if it isnt the future remains in S110 which we will hear about later in the year.
The fact there is no viable treatment for elderly AML remains a positive.