NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

Will there ever be a milestone that doesn’t take two years to reach? Labeling alone typically takes two months. But with NWBO, of course, it’s a minimum of six months to a year — because it’s “complex,” blah blah blah. Is it really that complex, or is management just incapable of handling tasks in a timely manner?

The biggest hope created by FINALLY getting the application submitted into the hands of the MHRA was that NWBO would no longer be able to create delays and that MHRA would give us an up or down decision and one way or another we would know if the last decade plus had been wasted.

I stated as much multiple times here and not one person, especially on the Pump Crew said ‘Errrr Happy, just so you and everybody knows, the application is going to be more of an extended dialogue than something the regulator reviews and NWBO can drag things out an extra 60 days each time MHRA asks a question. Oh and Happy, there’s no limit to the number of questions MHRA can ask (except that imposed by their consciences when they think of how many GBM die because of each one).

So either all the folks talking (and wittingly or not, pumping) about eager and quick the MHRA would be ‘because NWBO has a good relationship with them and the UK wants to first be etc. did one of two things:

1. They spoke out of ignorant over optimism and no real knowledge of the process, in which case any positive speculation about time frames or short cuts. by any of those folks should be viewed with even more than the usual skepticism.

Or (and this is worse)

2. They knew in advance about how the MHRA process worked including RFIs but chose not to mention anything about it, for reasons of their own.

I think #1 is more likely overall.