NorthWest Biotherapeutics Inc (NWBO)

[Rkmatters]

Consent form is for 36 months after enrollment. End of trial is considered 36 months for non-crossover patients.

"The duration of your participation in this study is approximately 36 months. Long-term follow-up may be beyond the 36 months of the clinical trial. Your participation in this study is entirely voluntary. You should read the information below, and ask questions about anything you do not understand, before deciding whether or not to participate. " -- consent form

http://neurosurgery.ucla.edu/Workfiles/Site-Neurosurgery/Brain_Tumor_Program/DCVax%20Consent.pdf


"All subjects who have undergone the leukapheresis will receive up to 10 injections of the study agent or placebo over the course of 3 years, except for those patients for whom it is determined that it is not safe for them to receive either treatment. All patients in the study will be followed for the collection of data related to progression or re-growth of brain cancer, and survival for a period of up to 36 months. In addition, long-term progression or re-growth of your brain cancer as well as survival, or overall survival will be followed beyond the 36 months of the clinical trial." -- consent form

http://neurosurgery.ucla.edu/Workfiles/Site-Neurosurgery/Brain_Tumor_Program/11-000686-%20Main%20ICF%2007Nov2012.pdf

See page 14 for treatment MRI visit up to 36 months post enrollment.

We've all seen this below many time. Their are still enrolled patients who potentially have not received their last consented dosage.

"Prior to the last dose of the last patient enrolled in the Phase III trial for DCVax®-L or After the last dose of the last patient enrolled in the Phase III clinical trial for DCVax®-L but before any submission for product approval in any jurisdiction or after the submission of any application for market authorization but prior to receiving a marketing authorization approval: in any of these cases, the fee shall be $3 million." -- 10Q