Replies to post #61563 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

“With regard to the impetus for this rapid action, we began working immediately on this review and submission strategy after being informed of the survival results. This was prior to BMS having been informed of the results since they were still blinded,” Pazdur said matter-of-factly to The Cancer Letter (The Cancer Letter, June 2).

“Patients and physicians need to be informed about these findings and this was the impetus for the rapid inclusion of the survival data in product labeling.”- The Cancer Letter December 4, 2015

If you look closer you might find there is no way this could be happening here. Or you can just decide it definitely is! And I like that better!!

Go NWBO!! I'm so excited!!!!

[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".