NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Not one rational explanation other than DSM seeing an efficacy signal through death rate has ever been given on this board. Not one.

Has been given many times.

. The DSMB gave a futility recommendation in the 2015 planned IA peek

. NWBO, as is their legal, regulatory and ethical right elected to continue the trial in hope a long OS tail would save it.

. In discussions with the FDA, the FDA allowed the trial to continue treating, but denied them the ability to recruit new patients. It was over that time when LP was stating they hoped to restart recruitment soon.

. NWBO had discussions with the FDA lasting over a year where they tried to change the trial design to get recruitment restarted, but the FDA did not allow.

. LP asserted the issue was not necessarily a bad thing. And that could be true as a log OS tail might always have been the best shot.

All the above is consistent with how the FDA handles a futility rec, almost identical the CVM case.

As far as your theory, it has huge holes. First, the FDA does not issue trial holds for efficacy. It is up to the sponsor to decide. Then you also have to explain why LP wanted to restart recruitment. And last, and perhaps most significantly, a trial that is halted for efficacy would always show overwhelming evidence of a positive outcome. It would be insane to delay the trial years and change endpoints when you know you have a winner.