While anyone here should agree not all risk is eliminated from the approval process for DCVax-l, the Omburtumab rejection comparison you found for is well off the mark.
For starters, regarding Omburtamab, the agency said that it could not be ascertained that the patients in the external control group selected for reference by the company, had a similar underlying prognosis as those treated with Omblastys in the study.
Whereas, GBM has an extremely well understood underlying prognosis.
That’s just one point. There are so many more factors beyond just that boding well for the DCVax-l data. Have a nice Friday evening.