NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Horseb4CarT,

I agree 100% with your statement which is why it is the perfect cover for not disclosing anything more even IF FDA has no problem with NWBO disclosing the reason for the hold. In my estimation the hold had to do with derived benefit being noted with treatment and more so with early treatment vs crossover. FDA would have no reason to hold the company back from disclosing a recommendation of halt for efficacy any more than it does for any other company. The obvious reason here for not disclosing a potential recommendation to unblind in 2015 is that outcomes appear to be improving over time and in 2015 the OS data and even PFS data was not fully mature or adjudicated to verify that an actual PFS event occurred when the primary endpoint is based on PFS. Any possible recommendation by a DMC panelist to halt the trial for efficacy at that point based on clinical observations or OS response and or who might have seen unadjudicted PFS as futile but who might also have had an undisclosed conflict of interest would definately have had the potential to create a major headache for NWBO. The discovery of the halt on the German regulatory site by accident without the company ever having submitted a press release prior would have put NWBO in deep trouble had the halt been for bad news. None of the law suits could find any. The fact that this was being done without fanfare suggests something good was happening that regulators were trying to make necessary adjustments for under the radar. Trying to keep everything quiet has been as much of a pain for regulators as it has been for NWBO.. almost. Lol. Best wishes.