Not an expert in this area, but my impression is that CAR-T trials show remission rates to be much higher that anything I have seen even with the unintended consequences. More studies will be required, but at some point FDA will approve it. The mortality of these malignancies are quite hi with the current standard of care. Don't see the FDA seeking a hi hurdle at least for some of the hi failure cases.
I am long CPXX, but not JUNO. I think the probabilities of early approval for VYXEOS is hi and sooner than later give the urgent need. Market cap at $575M so the risk reward/risk is ok, though I bought the stock after the big jump. Surprised the company has not been bought soon after the recent trial results were announced.