Replies to post #555489 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Were not some board members posting that under an ORBIS submission, there could be a coordinated approval by the cooperating regulators?

Orbis is a program where the FDA runs a review and other parties may be able to join in.,

Once the staff review (possibly joint) completes then the individual RAs make their decisions. The FDA has been acting faster on actually approving after the review.

[beartrap12]

Hankman, Linda made it clear that the product application would go out to multiple regulators, which might be a tip of the hat toward ORBIS, which involves multiple countries or RAs. She certainly at this point knows who they’ll submit the application to, after all, they have to fill in the paperwork for the correct filing, but they obviously don’t want to tell us yet. I don’t know why. I found it interesting that she never refers to the application as a BLA, just as a product application. I don’t know if that’s significant. Is it called a BLA in the ORBIS program, or in other specific programs? Maybe somebody who understands the application process can answer.