NorthWest Biotherapeutics Inc (NWBO)

[Nick119]

Also, this talks directly about the trial:

"It is notable that the three largest RCTs initiated to date have faced huge logistic/financial problems, as follows: (1) The EudraCT 2009-018228-14 trial aimed to include 146 study objects but was abruptly closed by the sponsor after the inclusion of 135 patients. The reasons for this were kept confidential. Nevertheless, the scientific data were made available, were extremely well-documented, and were partially transferred onto the platform of the EU Project Computational Horizons in Cancer (www.chic-vph.eu). Data on 132 patients were finally brought into a new study, named the Glioma Translat Study, and published [166,167]; (2) NCT00045968 was designed to include 348 study objects with PFS as the primary read-out and OS as the secondary read-out. Eighty sites in four countries were used for recruitment. The study screened 1268 patients and ended up with 331 randomizations into the main study [160]. Patient recruitment was initiated in 2007 but was paused from 2009 to 2011 for economic reasons. The final patient was enrolled in November 2015. This resulted in a recruitment period of nine years, an effective inclusion period of six years, and a mean of four patients per recruiting site at an effective rate of less than one patient per year per site. Five years later, at the time of writing, the final results regarding the randomized data collected on these patients and the answer to the primary question (PFS) have not yet been published; (3) NCT02546102 suspended further patient randomization due to financial reasons [168]. It is not clear how many patients had already been recruited into the trial."