1. Yes, it's because it's standard of care. That's the foolproof way to end up with approval. Which is to prove you're better than what is currently being used. You can also prove you're just as good but have some other benefit. So that's the main reason for the setup. But it's also because checkpoint inhibitors haven't shown to be effective in mss colorectal cancer. Since we now know that there's a very good chance that LL helps turn tumors hot, maybe a checkpoint inhibitor on board with LL could become beneficial in this particular type of crc. Wouldn't that be a boon to whoever markets those giant oncology drugs that desperately need extended patent life and new indications?

2. I'm not the right person to answer this one. I feel confused as a Lionel Hutz taking a basic law exam when it comes to deciphering exactly how this thing is going to go down.