NorthWest Biotherapeutics Inc (NWBO)

[Dan88]

I think we are talking the same, with difference being that I think it's a common sense that nwbo should and ought to come up with a "completely new SAP" for an almost "completely new test matrix," which is not to test merely PFS, mOS/OSs as designed for a short-term (my 400m, 800m analogy run) test, but to also and most importantly test long-term OSs, such as landmark 3-, 4- and 5-year OSs (my marathon analogy).

So the previous SAP becomes irrelevant, and it must be rewritten. In a sense the current SAP should be regarded as it's an "original" SAP.

In many occasions, both Lindas and Bosch have said the trial has adaptable design, and I don't think it will be any difference otherwise since the trial will produce long-term data. If we indeed see around 20% 5-year survival rate the SAP must be able to capture and accommodate that in an undeniable way.

And I strongly believe FDA holds the same view too as it is evidenced in its March proposal, and our future BLA when submitted will be evaluated by FDA in a new way as it has proposed, because that's the only scientific way to measure it.