NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Here's a very enticing theory.


Germany does not want the pseudo progression group in the trial because they already know those patients respond exceptionally well to DCVAX-L, and more importantly, the efficacy can be determined exceptionally fast (see posts by doc, flipper and others). Thus, they are anticipating the pseudo-progression group will be halted before they start their enrollment.

Why would Germany know this? I think you can start with the clinical experiences in Cologne Germany and in the compassionate use cases in Israel and Great Britain. John has a lot of information he found in his internet research on the Cologne program.

It makes a great deal of sense to me, but I'm probably not taking enough time to lay it out based upon the other factors making this likely.

I'll just mention one. Germany is the toughest Country in Europe for a company to receive manufacturing approval, clinical trial approval and compassionate use reimbursement. In accomplishing this, they check every nut and bolt before giving the go ahead. One of the only things they required was that NWBO not include the pseudo progression enrollment and separate analysis in their part of the enrollment program. Think about that. They would not want to start enrolling people who might tomorrow be eligible for commercially approved (through Germany's expansive compassionate use program) DCVAX-L's treatment. Thus saving some patients from the placebo.

(Of course, imho any possible divided halt and continuance between the 2 groups could happen in reverse order, possibly due to the trial chronology)