NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

But how do you explain this...

The FDA already was processing a BLA submission for Opdivo in that setting when this happened.

The submission was based on a marginal trial with PFS as an endpoint. BMY was hoping for an AA based on that.

While looking at the BLA, the FDA did as described and looked into another trial with O/S as an endpoint. Certainly an amazing case, but kind of fits with the concept that in examining a BLA, the FDA will look at everything they can find.

The only other case I know of where the FDA "peeked" was the same. They had a BLA for Yervoy on the table and peeked into another trial.

I am not aware of any trial where the FDA has jumped in w/o either a submitted NDA/BLA or "concern".