NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

Quote AVII:
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First of all, they can't stop a study for overwhelming efficacy based "on a look at data that they may not have requested by NWBO or their DMC". That would be an "unplanned interim". Now, unplanned interims can be performed (and there are valid reasons to perform them), but then going ahead and stopping (claiming efficacy) based on that unplanned interim is really problematic.
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"on a look at data that they may not have requested by NWBO or their DMC".
--> "on a look at the data that may not have been requested by NWBO nor their DMC."

Last minute edit gone bad.

I will read your post a couple of times, and maybe more will sink in, but for the moment:

The current hold is at full enrollment in the old 6 months pfs threshold scheme. If the hold was for data collection by the Germans to gauge reimburement for HE, for example, then it could be that the point at which this look was going to take place was agreed upon long before the trial "enhancements" and the Germans may have chosen to keep that event threshold in spite of the enhancements.

The current level of recruitment and enrollment appear ideal for simultaneous consideration of AA based on PFS as surrogate to a co-primary metric of OS, and regular early-approval based on PFS with PFS as a co-primary endpoint. When I look back over Flipper's equation examples that is probably what I will see, now that I know that there is such thing as early regular-approval based only upon the primary endpoint.

(by the way, why is there no nifty acronym for early regular approval? It is not just regular approval, because it is early. That is very different from regular approval and fully deserves it's own f%#&n acronym. Over the last six months, how many times has AA been brought up? How many times has early regular approval been brought up? What is that ratio? Why so extreme a ratio?)

If this look at the data for consideration of both AA and early regular approval would require an alpha spend that would make this a do or die situation, then another description of the situation might be, "Win or Go Home", though LP was more likely referring to the very large (apparent) expenditures for large scale mfg.