IMO, a must read for anybody with a significant position (or thinking about one) in Moderna. Read carefully the pieces about whether Moderna will go for accelerated approval. I am firmly convinced they will announce accelerated approval filing shortly after they start enrolling in the confirmatory P3.
In fact, Holen referred to that trial as confirmatory (a term of art found in FDA guidelines for accelerated approval of oncology treatments) when answering a question. With 30 years of oncology research, he certainly knows how to use the term properly in this context.
Hoge, in a comment on accelerated approval path said words to the effect that the only thing left to do is start enrolling in a P3 trial which they intend to start in 3Q. Note "thing" in the singular.
IMO, it will take some kind of bad event or result to prevent accelerated approval.
