NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

The DMC may have recommended they halt the study for futility after seeing an excessive number of PFS events in DCVax-L group, and/or suggested they pause screening and submit info to regulators to engage them in dialogue about it, and perhaps request changes to the trial or say they want to continue despite what the DMC saw and recommended, as the blind has been maintained. And maybe they were able to use info outside the trial as well to explain immune response in GBM can cause false PD signals and try to use that to help their case. Would regulators agree to that? Revamping trial with OS co-primary or just primary with no crossover? Imo probably not, but I'm no expert.

But if a sponsor pauses screening they don't need regulators to allow them to screen again. Only if regulators placed a hold on an IND do they need them to remove that hold.

If you want to assert FDA has not placed a hold this is the best evidence (8-k from Dec):

"There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which... imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries."

https://www.sec.gov/Archives/edgar/data/1072379/000114420415073181/v427716_ex10-1.htm

Although the preamble "Except as set forth in the SEC reports," could disqualify that mention, it would be quite inflammatory for NWBO to have written that if one had really occurred, imo. But maybe...

So either

-NWBO initially paused screening, and has maintained this screening halt until today, without regulators issuing or maintaining any hold

-NWBO initially paused screening, and then submitted info to regulators, who after reviewing or after some time of dialogue then issued a partial clinical hold, thereby the 8-k that says they had no outright hold in Dec was true, but before March (10-k release) there was an actual partial hold placed, and so we have that language in the last 10-k.

-Regulators were all along the cause of initial pause in screening and current partial hold, being both one and the same

Take your pick I guess :) I think the second one sounds about right.