Replies to post #289857 on NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

Terrific post and you really seem to know what you are talking about

A company investing so much money in a trial without thought in advance to how the data would be analyzed would just be incredibly sloppy (and hopefully not the case for NWBO)

Simply described:
Ofcourse they had. Their first focus was more toward PFS, as any other sponsor would working in the field NWBO is working in. Then you got the pseudo-problems. And now the focus is most probably more in the direction of OS then PFS (as an endpoint)

For this a new SAP was needed.
Again I expect the endpoints in the SAP to be accepted by the FDA.
But it remains uncertain to the market then if the new endpoints were the direction when the trail was designed in the first place.

[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.

[sentiment_stocks]

I believe they had defined a fairly clear analytic plan even in the protocol, and I do believe there was a statistician working with the DMC out of the North Carolina Wake Forest area - who I'm thinking was likely brought in via Curt Furberg, the original DMC chair, who also served at the same time on the SAB for the competing dendritic cell company Immunicum, and whose brother served on the same, as well as the BOD for that same company (unbeknownst to NWBO).

But it was never really clear in the protocol as to how they intended to measure PFS and OS, only that there was .02 dedicated to PFS. That's why I've always thought there was .02 for PFS, and if it was stat sig, that .02 moved over to OS giving it .05 instead of just .03. But again, this was never made clear.

[biosectinvestor]

I do not know if you’re for real, but clearly you’re not paying attention to developments that allow even large companies to address changes during the course of their trials and also to revise their SAP’s. This is not the first company, and given changes in the entire approach, it won’t be the last.

This is also not a drug, it’s a biological, which in many instances involves very new technologies where much of the human treatment learning occurs during the course of the trials that are often happening for the first time during that trial.