NorthWest Biotherapeutics Inc (NWBO)

[froggmister]

Yes, individual patient-level data was used

Sorry Slave, Ex is right on this. What I haven't read Ex explaining is why, if the ECA's without patient level data were such an obvious deal breaker, why did:
1. MHRA accept the application
2. MHRA refer to CMP and then work another year on the application
3. MHRA not only extended compassionate use but expanded it

Dr. Liau with Kate Neville on Neurology Journal Podcast, March 2, 2023

Dr. Liau: The patients treated with DCVax in the study were compared with the control arms of contemporaneous matched external controls who receive standard of care alone. To mitigate some of the limitations using external controls we did use a novel methodology to neural oncology called a MAIC analysis, which stands for Matching Adjusted Indirect Comparison Analysis, which matched patient characteristics between the trials as best we could at the population level. However, we were unable to obtain individual patient level data from the previously published comparator trials so we're not able to do individual patient matching which we are all aware is a current limitation with the use of external controls, so I'm actually hoping that our publication and the discussions around, it will spur the sponsors of these clinical trials to publicly release their individual patient data so that we as a field can further innovate and get regulatory interest in the use of external control arms in neurology and oncology trials. Because for patients with a deadly disease I think there's less and less interest in being the placebo control arm for large randomized controlled trials, especially since the data of standard of care is actually pretty well known from trials that we've done over the past 10 to 15 years.