Sure that is possible. I cant really comment on how probable it might be though. What often happens is a Phase II trial is considered "pivotal" and is tied to a roll-over Phase III after an interim analysis of the data. To be able to roll subjects over to the "extension" into Phase III typically saves some time but additional new subjects would still need to be recruited as well. I dont work for the FDA or EC so it is hard to say what they might require. Im just commenting per my own experience as a study monitor for various sponsors. Ive been involved in many studies over the years where the FDA has pushed for more data. Ive also been involved in oncology studies that have been halted abruptly for various reasons. It is never a clear, cut-and-dried path. Each phase depends on the findings of the previous phase. You can also see promising efficacy results in Phase II in a smaller sample-size that ends up not to be replicated when the sample size is increased in Phase III. Bottom line, making assumptions in this industry will frustrate the hell out of you.
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