Replies to post #6228 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

The timing of it all certainly is suspicious...

[longusa]

Flip, yes, if it occurred, I think it would have worked something like this:

NW applies a while go for early access (as they told us in their presentations), PEI then starts reviewing non-Phase III data. Meanwhile, NW, FDA, and PEI meet to determine how PEI could get access to the Phase III data. Possible outcome could be 'when interim event milestones hit, PEI can have access just as DMC does, while NW remains blinded'. This would also explain the announcement timing coming after the 1st interim in approx. the same timeframe as we expect the efficacy interim outcome.

As well, I have dealt with German companies, press, and people many many times over the years in business, and if I can hazard a generalization across all that experience, I would characterize the attitude seen as relentlessly pragmatic and data driven. I simply think the PEI would have insisted on access to that data to make the best decision possible. All the above JMHO of course.

[Jack2479]

IMO no leakage of data from the DMC is allowed period as surely this would completely undermine a double blinded trial? I can't see how this could be shared with the Germans but I'm open minded to other opinions. The delay in releasing German approval was more than likely to give the FDA every opportunity not to be left playing catch up. Linda is a smart woman. The delay in an update along with a 4000square foot ASCO booth sends a very clear signal...something big is brewing!!!