Going to the way-back machine to recall how this whole combo trial got formed, It was a big win for the FDA to allow us to use safety data from the investigation Mono trial for the pivotal Combo trial. It meant that the Combo trial did not need the much larger population of patients to get to BLA. I don't think the same win can be used to justify the possibility the same safety data could result in a Mono approval without a pivotal trial.

I have not heard any possibility that a mono pivotal trial will not be required, just that the size of the trial could also be small and short because of the Combo trials/approval. I think they refer to it and a label expansion because it is the same use and same drug, so this is an addition to a previous approval.

However, last year when the investigation trial was taking place, there was rumors/discussions that the FDA could convert the investigation into pivotal. It seems like this faded away, and it is likely because the FDA likes a trial that sticks to a protocol and the data supports that protocol. Investigation trials tend to have modifications as data educates how the drug works. It could still happen and the size and detail of the Combo BLA might be an indicator that the FDA is looking at Mono approval, but it would be a surprise if so.