NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

She was referring to the halt overall IMO. Can’t be due to pseudoprogression because patients continued to be enrolled for the next three months and all were placed on active therapy, none on placebo. The trial was never halted. New screening was halted when enough patients were screened and could be added to complete enrollment in the treatment arm.

If there were any question as to the safety of DCVax, there is no way FDA would allow new patients to go on active treatment until that was sorted out. If there was still a question of efficacy, placebo would have been retained. If it were a question of manufacturing and/or storage, no patient new or existing would have received active drug until the manufacturing issues were sorted out which would have taken months to years.

There is only one plausible answer to a screening halt that continues enrollment with all new patients being placed on active drug….oh yeah, and keeping an EAP open in case the company chose to make drug available outside of a trial.

EAP is short for EARLY ACCESS Plan.