NorthWest Biotherapeutics Inc (NWBO)

[antihama]

It seems the SAP sign-off by regulators is the biggest rate-limiting factor. LP hedging her statements about time-line because she does not know how long the FDA will take to sign-off on SAP.

Thanks Brad for that info. Hoping this would be discussed as I pondered in post 203832

Recently, I posted the example of Halozyme where they switched PFS to a secondary endpoint and OS as primary and giving all alpha spend to OS. I cited Halozyme taking 4 months, and counting, of communication w the FDA including a type C meeting to do this. Halozyme had the benefit of still recruiting patients in their study which is not the case w NWBOs study which can be more problematic. This is one of the questions I would love answered at the Annual meeting - "Will revising the Statistical Plan need Agency buy-in, and if so, what is the minimum amount of time this will take? And in revising the SP will you be revising the endpoints?" While one may argue back and forth if the PFS primary endpoint will reach SS, why bother? Initially, the PFS endpoint was going to be used to get AA and OS to get full approval but that ship has sailed. We got OS in hand now. Once they get their Stat Plan signed off the rest of the steps to unblinding should go quickly. Again, I would love to have this Q asked at the Annual Meeting, it would tell us a lot.