RE:Adcomm green light odds Phase 3B are not, (and have never been) a prerequisite to getting a green light. 90% of cases are done with Phase 1, Phase 2A/2B. and Phase 3. In my experience, delays usually include repeated Phase 2 studies dealing with Lot consistency, comparator studies and non-inferiority.
Also, oncology drugs, which are cytotoxic by nature are assessed differently than most small molecule drugs. This drug in particular is not seeking a `first-line`indication on its label, which will further alter the way things are reviewed.
Again, this is strictly my personal opinion, but given the data they have, and the indication they are seeking, it seems like a solid plan.