ilovetech, I don’t think it’s a mystery. DCVax is a novel cell therapy, which requires pioneering in nearly every aspect, and is unlike any other drug on the market, so not comparable. Apparently, there was still significant manufacturing development work left, in order to solidify the “quality” module of the application. Last year, we were told that there were 5, then 6, workstreams that were prerequisites to filing an application. When those workstreams were finally revealed this spring, it became pretty clear to me why it’s taken so long to file. Northwest Bio understands that failure is not an option, and is not willing to risk having their application rejected.
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