NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

SAP reality check.

This is not a particularly complicated or unusual trial design. PFS + OS is very common as an endpoint pair. In cancer trials, post progression OS is confounded by numerous channels. Crossover by design, use of the experimental drug that has already been approved in second line and use of other drugs (experimental or not). psPD and similar are not unique to this trial.

The 4RAs is not a lot for a P3. 11 for AMRN's P3, 3 for IMUN's and 23 for CLDX's (examples often discussed around here with similar sized companies).

We are talking Statistical Analysis Plan. Not the full trial design. Not the BLA. And the latter are more like 6 months to submit.

This has been going on for a year now. Either NWBO is BS-ing or slow playing it, or the RA's (particularly FDA/PEI) are saying they do not like it.

And if the trial data is so good it speaks for itself, why risk some novel plan with the RA's. With this size trial and length of data, any OS that clearly separates between arms will be stat sig on the original analysis plan.